STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD ) OF MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 05-1445PL

)

MARK K. SACHS, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, a final hearing was held in this case on June 17, 2005, at Miami, Florida, before Administrative Law Judge Michael M. Parrish of the Division of Administrative Hearings.

APPEARANCES

For Petitioner: Lynne A. Quimby-Pennock, Esquire

Department of Health

4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265

For Respondent: Roberto D. Stanziale, Esquire

600 South Andrews Avenue, Suite 406 Fort Lauderdale, Florida 33301

STATEMENT OF THE ISSUE

This is a license discipline case in which the Petitioner, by means of a four-count Administrative Complaint, seeks to take disciplinary action against the Respondent on the basis of his

alleged violation of subsections (m), (q), (t), and (nn) of Section 458.331(1), Florida Statutes (2002).

PRELIMINARY STATEMENT

At the final hearing on June 17, 2005, the Petitioner offered five joint exhibits, all of which were received in evidence. The Petitioner also presented the testimony of two witnesses; Alan J. Yesner, M.D., (an expert witness) and

Mr. Julio Colon (an investigator with the Department of Health). The Respondent rested without presenting any evidence.

At the request of the Petitioner, official recognition was taken of the applicable statutory and rule provisions.

At the conclusion of the final hearing, the parties requested, and were allowed, until July 20, 2005, within which to file their proposed recommended orders. The transcript of the final hearing was filed with the Division of Administrative Hearings on July 6, 2005. By order issued on July 20, 2005, the deadline for filing proposed recommended orders was extended to August 19, 2005. Both parties filed timely proposed recommended orders containing proposed findings of fact and conclusions of law. The parties' proposals have been carefully considered during the preparation of this Recommended Order.

On August 24, 2005, the Respondent filed a motion seeking to reopen the record in this case for the purpose of offering additional evidence. The Petitioner filed a prompt response

objecting to the motion. By order dated August 25, 2005, the motion was denied.1

FINDINGS OF FACT

1. The Respondent, Mark K. Sachs, M.D., is presently a physician licensed to practice medicine in the State of Florida, and he has been so licensed at all times material to this proceeding. His license number is ME 49598. His address of record is 11440 North Kendall Drive, Suite 206, Miami, Florida 33176.

2. A legend drug is a drug for which a prescription is required. At all times material to this proceeding, Phentermine has been a legend drug which has been approved by the FDA for the treatment of obesity. It is not safe for a person to self- prescribe Phentermine.

3. Phentermine works through the central nervous system as an appetite suppressant. Phentermine has numerous side effects including tachycardia, a fast heart rate; palpitations; diarrhea; altered sensorium; agitation; restlessness; sleep disorder; and/or tremors. Phentermine is contraindicated for patients who have high-blood pressure; patients with underlying cardiovascular diseases, including peripheral vascular disease; patients suffering from hyperthyroidism; and patients with glaucoma.

4. Prior to prescribing Phentermine, a reasonably prudent physician would perform a routine physical examination of the patient. Such an examination would include at least the following: obtaining the patient’s height and weight; confirming the patient’s BMI (Body Mass Index); checking the patient’s blood pressure; looking into the patient's eyes; listening to the patient’s carotid arteries; palpating the patient’s thyroid; and osculating the patient’s heart for any abnormal heart sounds. A reasonably prudent physician would also include an examination of the patient's pulse, feet, and abdomen, as well as a basic neurological exam.

5. When prescribing Phentermine, a reasonably prudent physician would also develop and document a treatment plan for the patient. Such a plan would include follow-up with the patient to monitor any possible side effects or any possible complications.

6. At some time on or prior to August 7, 2002, Patient

   
   

   H.Y. filled out a web site order form and questionnaire. The medication ordered by Patient H. Y. was described on the order form as "Phentermine (yellow) 30mg - 90 caps." At the bottom of the order form there was a statement to the effect that Patient H.Y.'s credit card would be billed by Impact Health Care, Inc. The order form had a number of boxes in which the person placing the order was asked to provide personal information or provide

   "yes" or "no" answers. The information provided by Patient H.Y. included the following: (a) her email address, full name, and day time and evening telephone numbers; (b) details regarding the credit card to which the order would be billed, (c) a billing address, (d) a shipping address, and (e) answers to several questions in the section of the form described as "Medical Questionnaire."

7. The information provided in the "Medical Questionnaire" portion of the form included: (a) her date of birth; (b) her sex; (c) a question regarding high blood pressure (response: no); (d) an agreement not to take any over-the-counter medicines without approval from her pharmacist (agreed); (e) an agreement to monitor her blood pressure at least once every 14 days and to stop taking the medication immediately if the blood pressure is over 140/90 (agreed); (f) agreement to not take the medication if the person was pregnant, breast feeding, or trying to get pregnant (agreed); (g) answers to questions involving any current medical conditions, all medication currently taken, all medications intending to be taken while on this program, all allergies, any surgeries, anything in patient’s medical history the patient deems relevant (all answered “none”); (h) patient’s height of 5 feet, 3 inches, and weight of 173 pounds; (i) the answer “yes” to a statement that the patient has read, understood, and agreed to the patient responsibility statement

   and the informed consent; and (j) the answer “no” to receiving two special offers.

8. On or about August 7, 2002, the Respondent wrote a prescription to Patient H.Y. for a total of 90 capsules of Phentermine 30 mg.2

9. During the course of the investigation that led to the filing of the Administrative Complaint in this case, prior legal counsel for the Respondent provided the Department's investigator with more documents from the Respondent's medical records than the two documents identified as Joint Exhibits 2 and 3 in this case. The Department does not know one way or the other whether the documents it received from the Respondent's prior legal counsel comprise the entirety of the Respondent's medical record of his treatment of Patient H.Y.3

   CONCLUSIONS OF LAW

   
   

10. The Division of Administrative Hearings has jurisdiction over the parties and subject matter of this proceeding, pursuant to Sections 120.569 and 120.57(1), Florida Statutes (2005).

11. Pursuant to Section 458.331(2), Florida Statutes (2002), the Board of Medicine is empowered to revoke, suspend, or otherwise discipline the license of a physician for violations of Section 458.331(1), Florida Statutes (2002), which include, in pertinent part, the following:

    (m) Failing to keep legible . . . medical records . . . that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispenses, or administered; and reports of consultations and hospitalization.

    
    

    * * *

    
    

    (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) . . . [F]ailure 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.

    
    

    * * *

    
    

    (nn) Violating any provision of this chapter or chapter 456, or any rules adopted pursuant thereto.

    
    

12. In a disciplinary action of this type, the burden is on the Petitioner to establish the facts upon which its allegations of misconduct are based. The Petitioner must prove

    its allegations by clear and convincing evidence. The clear and convincing evidence standard requires that the evidence be found to be credible; the facts to which witnesses testify must be distinctly remembered; the testimony must be precise and explicit; and the witnesses must be lacking in confusion as to the facts in issue. The evidence must produce in the trier of fact a firm belief or conviction as to the truth of the allegations sought to be established. Slomowitz v. Walker, 429 So. 2d 797, 800 (Fla. 4th DCA 1983).

13. In this case, the Petitioner has failed to meet its burden of proof, because the evidence in this case is insufficient to prove by clear and convincing evidence all of the facts that are necessary to establish the violations charged in the Administrative Complaint. The two most devastating deficiencies in the Petitioner's evidence are the failure to offer evidence of the complete contents of the Respondent's medical records and the failure to offer evidence proving that the Respondent failed to do many acts it is alleged he should have done. Specific details are set forth in the following paragraphs.

14. Attention is directed first to the allegations of Count I of the Administrative Complaint, in which it is alleged that the Respondent violated Section 458.331(1)(t), Florida Statutes (2002), in that he "failed 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 circumstances, in one or more of the following ways." This quoted language is followed by a list of ten acts the Respondent is alleged to have failed to do. There is no clear and convincing evidence that the Respondent failed to perform a single one of the ten acts itemized in Count I. The only two people who know what the Respondent did and what the Respondent failed to do in his treatment of Patient H.Y. are the Respondent and Patient H.Y. There is no testimony by either of those two people about anything the Respondent did or anything the Respondent failed to do.

15. Even in the absence of testimony by someone who had personal knowledge of what did or did not happen, proof of what the Respondent did or did not do could be gleaned from or inferred from what is contained in, or what is missing from, the Respondent's medical records regarding his treatment of Patient

    H.Y. But in order to use the medical records as proof that certain acts did not occur (which can be reasonably inferred from an unexplained absence of any mention of such acts in the medical records), the entire medical record must be offered and received in evidence.4 In this case only part of the Respondent's medical records regarding Patient H.Y. were offered and received in evidence. Other documents from the Respondent's

    medical records of his treatment of the subject patient were provided to the Department's investigator, but were not offered in evidence.5

16. In sum: Count I charges the Respondent with a violation of Section 458.331(1)(t) by failing to perform ten specific acts, but there is no clear and convincing evidence of a single one of the alleged failures. Under these circumstances, the violation charged in Count I must be dismissed for insufficient evidence.

17. Count II of the Administrative Complaint charges the Respondent with a violation of Section 458.331(1)(m), Florida Statutes (2002), by reason of the allegation that "Respondent failed to keep written medical records justifying the course of treatment of Patient H.Y., in that Respondent has failed to provide any medical records that Respondent recorded an adequate medical history on the patient, or that the records justify the treatment of Patient H.Y. with Phetermine." Reduced to its simplest terms, it is alleged that the Respondent's medical records of his treatment of Patient H.Y. fail to contain certain information that should be in those records. And in order to show clearly and convincingly that something is missing from the records, the Petitioner must present proof of the contents of all of the subject medical records. There is no such proof here. Rather, the evidence establishes that there are

    additional documents in the Respondent's medical records concerning the Patient H.Y. Without having all of the records in evidence, the evidence is insufficient to prove that the records failure to include any specific item of information.

    Under these circumstances, the violation charged in Count II must be dismissed for insufficient evidence.

18. Count III of the Administrative Complaint (at paragraph 41) charges that the Respondent violated Section 458.331(1)(q), Florida Statutes (2002), by "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, by virtue of inappropriately prescribing Phentermine to Patient H.Y., in violation of those specific guidelines and standards for the prescription of obesity drugs, as required under Rule 64B8- 9.012, Florida Administrative Code." The specific guidelines and standards the Respondent allegedly failed to follow are itemized as follows at paragraph 40 of the Administrative

    Complaint:

    
    

    1. Respondent did not determine and/or

       validate the BMI of Patient H.Y. in order to justify the use of Phentermine;

       
       

    2. Respondent did not conduct an initial evaluation of Patient H.Y. to include an appropriate physical and complete history;

    3. Respondent did not order appropriate tests related to medical treatment for weight loss, or appropriate referrals as indicated by the physical, history, and testing;

       
       

    4. Respondent did not prescribe Phentermine by a written and signed prescription, but rather by an internet transaction;

       
       

    5. Respondent did not personally meet with Patient H.Y. and personally obtain an appropriate written informed consent from Patient H.Y. concerning weight loss treatments and potential benefits versus potential risks of weight loss treatments; and/or

       
       

    6. Respondent did not assure that Patient

       H.Y. undergo an in-person re-evaluation within 2 to 4 weeks of receiving the Phentermine, or a re-evaluation at least once every three (3) months thereafter.

       
       

19. For the same basic reasons discussed in paragraphs 13, 14, and 15 of the foregoing Conclusions of Law, the evidence in this case is insufficient to prove the violation of Section 458.331(1)(q), Florida Statutes (2002), charged in Count III of the Administrative Complaint. As discussed in the referenced paragraphs, there is no testimony in this case by anyone with personal knowledge about anything the Respondent did or anything the Respondent failed to do during the course of his care and treatment of Patient H.Y. And as further discussed in those paragraphs, inferences of any failures to act cannot properly be drawn from any absences of entries in the medical records of the

    patient's care unless the entire medical record in received in evidence, which did not happen here. Under these circumstances, the violation charged in Count III must be dismissed for insufficient evidence.

20. Directing attention finally to Count IV of the Administrative Complaint, in this count the Respondent is charged with having "violated Section 458.331(1)(nn), Florida Statutes (2002), by violating Rules 64B8-9.003 and/or 64B8-9.012 [Florida Administrative Code]," by reason of allegations that the "Respondent failed to maintain any medical records reflecting his course of action, including Patient H.Y.'s medical history, examinations, tests administered and their results, consultations, diagnosis and/or treatment plan prior to prescribing an obesity medication, Phentermine[,] to Patient H.Y."

21. For the same basic reasons discussed in paragraph 19, above, the evidence in this case is insufficient to prove the violation of Section 458.331(1)(nn), Florida Statutes (2002), charged in Count IV of the Administrative Complaint. As reiterated in paragraph 19, there is no testimony in this case by anyone with personal knowledge about anything the Respondent did or anything the Respondent failed to do during the course of his care and treatment of Patient H.Y. And as further discussed in several of the foregoing paragraphs, inferences of any

failures to act cannot properly be drawn from any absences of entries in the medical records of the patient's care unless the entire medical record in received in evidence, which did not happen here. Under these circumstances, the violation charged in Count IV must be dismissed for insufficient evidence.6

RECOMMENDATION

Based on the foregoing, it is RECOMMENDED that a Final Order be issued in this dismissing all charges in all four counts of the Administrative Complaint by reason of the insufficiency of the evidence.

DONE AND ENTERED this 3rd day of October, 2005, in Tallahassee, Leon County, Florida.

S

MICHAEL M. PARRISH

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 3rd day of October, 2005.

ENDNOTES

1/ There are several reasons for denying the Respondent's motion seeking to reopen the record. One such reason is the absence of any statute or rule authorizing the reopening of the record for the purpose of adding what is, in essence, impeachment or rebuttal evidence. Another more important reason is the fact that the purpose of Respondent's post-hearing motion is to revisit the admission into evidence of Joint Exhibit 3, which is one of several exhibits identified in the parties' Joint Pre- Hearing Stipulation as "joint exhibits." See page 4 of the Joint Pre-Hearing Stipulation in which the parties stipulate that "[t]he following joint exhibits will be offered into evidence." The itemized joint exhibits include one described as "copy of prescription executed by Respondent for Patient H.Y.," which is the document that was marked and received as Joint Exhibit 3.

Once an exhibit has been received in evidence by joint stipulation, there is no proper basis for reopening the record of the hearing for the purpose of impeaching or rebutting that exhibit.

2/ A copy of the written prescription was received in evidence as Joint Exhibit 3. The prescription is written on a form that has printed on it the name and address of an entity named Impact Healthcare. The Respondent's name is neither printed nor legibly written on the prescription form. The signature on the form can fairly be described as an illegible scrawl (which is not particularly unusual in the medical profession). Absent an expert in handwriting identification, the authorship of the prescription form cannot be determined from a mere examination of the information on the prescription form. The finding that the Respondent was the author of the prescription is based primarily on the stipulation of the parties, at page 4 of the Joint Pre- Hearing Stipulation, to the effect that the document received as Joint Exhibit 3 is a "[c]opy of prescription executed by Respondent for Patient H.Y."

3/ See Investigator Colon's candid testimony at page 102, lines

13 through 22, and at page 103, lines 19 through 25.

4/ One cannot say with any confidence that there is nothing in a patient's medical records to show that some specific action was taken by the physician unless one has the opportunity to read the entire medical record. In other words, one cannot say that a medical record contains no mention of some specific act until one has read the entire medical record. It is clear that the entire medical record was not offered as an exhibit in this case,

because the Department's investigator testified that there were additional documents, which documents were not offered in evidence.

5/ See page 102 of the transcript where the Department's investigator testifies that "there were other documents provided" with the same letter from the Respondent's prior legal counsel that provided the investigator with the documents that became the Joint Exhibits numbered 2 and 3.

6/ In reaching the foregoing conclusions that there is insufficient evidence to prove any of the four counts in the Administrative Complaint, the extensive expert witness testimony of Alan J. Yesner, M.D., has been neither overlooked nor disregarded. Quite to the contrary, Dr. Yesner's opinions have been carefully considered and have been found (in this case and in other cases in which he has testified) to be credible, logical opinions clearly expressed by a physician possessed of outstanding professional credentials. However, Dr. Yesner's expert opinions are insufficient to carry the day in this case because, through no fault of Dr. Yesner's, this formidable physician's opinions were based on incorrect or incomplete facts. Dr. Yesner's opinions are all based on the belief or assumption that Joint Exhibits 2 and 3 comprise the entire medical record of the Respondent's care and treatment of Patient H.Y. It is clear from the testimony in this case that there is at least one additional page of that record, and there is no evidence in the record of this case concerning what information is contained in the additional page(s). Because the facts proved at the hearing were fewer than and different from the facts upon which Dr.

Yesner's opinions were based, the expert opinions must be disregarded because they are predicated upon a factual scenario which was not proved at the final hearing.

COPIES FURNISHED:

Lynne A. Quimby-Pennock, Esquire Department of Health

4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265

Roberto D. Stanziale, Esquire

600 South Andrews Avenue, Suite 406 Fort Lauderdale, Florida 33301

Larry McPherson, Executive Director Board of Medicine

Department of Health 4052 Bald Cypress Way

Tallahassee, Florida 32399-1701

R. S. Power, Agency Clerk Department of Health

4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701

Timothy M. Cerio, General Counsel Department of Health

4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701

Dr. John O. Agwunobi, Secretary Department of Health

4052 Bald Cypress Way, Bin A00 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 Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the Final Order in this case.

Docket for Case No: 05-001445PL

Orders for Case No: 05-001445PL