STATE OF FLORIDA

DIVISION OF ADMINISTRATIVE HEARINGS

DEPARTMENT OF HEALTH, BOARD OF ) MEDICINE, )

)

Petitioner, )

)

vs. ) Case No. 05-2590PL

)

DONALD A. TOBKIN, M.D., )

)

Respondent. )

)

RECOMMENDED ORDER

Pursuant to notice, a final hearing was conducted in this case before Administrative Law Judge Michael M. Parrish of the Division of Administrative Hearings on February 2 and 3, and on May 16 and 17, 2006. The February session of the final hearing was held in Fort Lauderdale, Florida. The May session of the final hearing was held by means of a televideo conference between sites in Tallahassee and Lauderdale Lakes, Florida.

APPEARANCES

For Petitioner: William F. Miller, Esquire

Ephraim D. Livingston, Esquire Department of Health Prosecution Services Unit

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

For Respondent: Donald A. Tobkin, M.D., pro se

Post Office Box 220990 Hollywood, Florida 33022-0990

STATEMENT OF THE ISSUES

This is a license discipline case in which the Petitioner seeks to take disciplinary action against the Respondent on the basis of charges set forth in a three-count Administrative Complaint. The Administrative Complaint charges the Respondent with violations of paragraphs (m), (q), and (t) of Section 458.331(1) Florida Statutes.1

PRELIMINARY STATEMENT

During the course of the final hearing in this case, the Petitioner presented the testimony of three fact witnesses (police officers) and one expert witness (Dr. Macool). The Petitioner offered a total of seven exhibits, five of which were received in evidence.2 During the course of the final hearing, the Respondent did not call any witnesses to testify at the hearing, but did present the deposition testimony of himself and of another expert witness (Dr. Miller). The Respondent offered a total of thirteen exhibits, twelve of which were received in evidence.3 At the request of the parties, official recognition was taken of several matters.4

At the conclusion of the hearing, the parties were allowed

10 days from the filing of the transcript of the final hearing within which to file proposed recommended orders. The transcript of the final hearing was filed with the Division of Administrative Hearings on June 1, 2006. Thereafter, all

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.

FINDINGS OF FACT

1. At all times material to this case, the Respondent, Donald A. Tobkin, M.D., has been licensed, and continues to be licensed, to practice medicine in the State of Florida. His license number is 30942.5

2. Sometime during the month of December 2004, the Police Department of Hollywood, Florida, (HPD) received information from a confidential informant that the Respondent was soliciting drug-prescribing business and was writing inappropriate and excessive prescriptions for controlled substances. On the basis of that information, the HPD initiated an undercover operation to investigate the information received from the confidential informant.

3. As part of the undercover investigation, on the evening of January 20, 2005, at approximately 9:56pm, an HPD female detective named Nicole Coffin made a telephone call to the Respondent's telephone. The Respondent answered the telephone and identified himself by name. Detective Coffin pretended to be a person named Melissa Beech. She pretended to be a person who was seeking to obtain OxyContin, which is a Schedule II

   controlled substance. During the entire undercover investigation, Detective Coffin pretended to be a drug-seeker while interacting with the Respondent. On the telephone she told the Respondent that she wanted a prescription for OxyContin and also told the Respondent that a girl somewhere on Federal Highway had given her the Respondent's card and had told her she could call the Respondent if she needed a prescription.

   Detective Coffin, in her role as Melissa Beech, did not initially describe any medical complaint to the Respondent; she just said she wanted a prescription for OxyContin. In response to the request for a prescription for OxyContin, the Respondent told the make-believe drug-seeker that he could provide the requested prescription, but that they would have to have a "medical reason" for such a prescription. The Respondent then asked the make-believe drug-seeker if she had ever been in an automobile accident. The make-believe drug-seeker answered "yes," because that is the answer she thought would provide a basis for a "medical reason." The Respondent then proceeded to ask the make-believe drug-seeker a long series of leading questions which, if answered "yes," could provide the appearance of a "medical reason" for the requested prescription for OxyContin. This series of questions was for the purpose of establishing a contrived "medical reason" for the prescription sought by the make-believe drug-seeker. There never was, and

   there never appeared to be, any real "medical reason" for the prescription sought by the make-believe drug-seeker. The sole purpose for the many questions asked by the Respondent, and for the Respondent's written notations related to those questions, was to create the illusion, or the false impression, that there was a "medical reason' for the prescription when, in fact, there was no such reason.

4. The detective who was pretending to be a drug-seeker answered "yes" to all of the leading questions asked by the Respondent. She answered "yes," even when that was not a truthful answer, because she was trying to give the answers she thought the Respondent wanted to hear.6 The Respondent's leading questions included questions asking about such things as whether the make-believe drug-seeker had ever had an automobile accident, whether she had suffered a herniated disk as a result of that accident, whether she had had an MRI, whether she had had any subsequent accidents, whether she had tried any other drugs to relieve pain, whether she had used Oxycontin in the past, and whether in the past the Oxycontin had relieved her pain.

5. During the course of the first telephone conversation between Detective Coffin and the Respondent a number of significant matters were not discussed. The Respondent did not discuss the possibility of surgical treatments to treat the back

   pain described in response to the Respondent's questions. The Respondent did not discuss the necessity of reviewing the MRI or X-rays that supposedly would confirm the "herniated disc" he had inquired about. The Respondent did not discuss the necessity of obtaining future MRIs, X-rays, or other diagnostic tests to evaluate the "severe back pain" supposedly described by Detective Coffin in her role as Melissa Beech. The Respondent did not mention that she would need to have any follow-up visits with the Respondent.

6. During the course of the first conversation between Detective Coffin and the Respondent, she told the Respondent that she had previously been obtaining Oxycontin "off the street" and that she was seeking a prescription from the Respondent because her street source had "dried up." She also told him that she had previously taken Valium and Percocet.

7. During the course of the first telephone conversation Detective Coffin, pretending to be a drug-seeker, told the Respondent that she suffered from back pain as a result of the make-believe automobile accidents. She did not say that she was currently experiencing pain at the time of that telephone conversation. During the first telephone conversation the Respondent did not ask the make-believe drug-seeker any questions about her menstrual cycle, about whether she was pregnant, or about whether she had had any prior pregnancies or

   had ever had any children. However, in his written notes the Respondent included notations that purport to be answers to those unasked questions. Similarly, the Respondent did not ask the make-believe drug-seeker any questions about her consumption of alcohol, but included in his notes notations that purport to memorialize the answer to that unasked question. The Respondent's "history" notes also report that he warned the make-believe drug-seeker that OxyContin tablets should not be crushed or broken, even though he did not include any such warning in his telephone conversation with the make-believe

   drug-seeker.

   
   

8. During the first telephone conversation, Detective Coffin was never asked about, and never provided any information about, whether other physicians had either prescribed OxyContin for her or had refused to prescribe OxyContin for her. The only prior sources of OxyContin she mentioned to the Respondent were non-prescription illegal sources on the street.

9. The Respondent never discussed with Detective Coffin the possibility or necessity of a more structured medical treatment plan for addiction. The Respondent never discussed with Detective Coffin the possibility or necessity of a more structured medical treatment plan to treat a complaint of "severe pain."

10. During the course of the first telephone conversation, the Respondent agreed to provide a prescription to the make- believe drug-seeker for a total of sixty-two 80-milligram OxyContin tablets. It was agreed that the make-believe drug- seeker would pay $100.00 for the first prescription and that the Respondent would provide similar prescriptions in the future for

    $50.00 per prescription. Towards the end of the first telephone conversation the Respondent told the make-believe drug-seeker that he had another matter to attend to and that she should call him later to arrange the time and place for the two of them to meet later that same evening.

11. During the course of the first telephone conversation, which lasted for approximately 14 minutes, the Respondent

    made written notes of the answers given by the make-believe drug-seeker. Those notes were prepared in such a manner as to resemble the types of notes customarily made by physicians who are making a medical record of information elicited from a patient.

12. A number of the details recorded in the Respondent's notes of the first telephone conversation were inconsistent with the information provided by the make-believe drug-seeker. Specifically, those notes contained a significant amount of information that was never uttered by the make-believe drug-

    seeker. The fictitious and false history details memorialized in the Respondent's notes are intentional falsehoods.

13. Later that evening, at approximately 12:20am on January 21, 2005, Detective Coffin, still pretending to be the drug-seeking person named Melissa Beech, placed a second telephone call to the Respondent. She spoke with the Respondent for about three minutes on this occasion. Most of the second conversation consisted of providing the Respondent with information about the location where Detective Coffin would be waiting for him and information about where the Respondent should park when he arrived.

14. Law enforcement officers of the HPD attempted to record both of the telephone conversations between the Respondent and Detective Coffin. Both of those attempts were unsuccessful. There is no recording of either of the telephone conversations.

15. Sometime later that evening, during the early morning hours of January 21, 2005, the Respondent met the make-believe drug-seeker at the motel or efficiency apartment. He entered the room where the make-believe drug-seeker was pretending to be staying. Prior to his arrival, two cameras had been concealed in the room by the HPD police officers. During the entire time the Respondent was in the room the two cameras were attempting to record everything he said and everything he did, as well as

    everything said or done by the detective pretending to be the drug-seeking person named Melissa Beech.

16. After entering the room, the Respondent spoke with the make-believe drug-seeker and asked her additional questions related to her request for a prescription for OxyContin. He made some written notes that purported to be summaries of her answers. During the course of the meeting with the make-believe drug-seeker the Respondent provided her with a document titled "Patient's Acknowledgement," which she signed, but did not read. That document contained information about the patient-physician relationship, about what was expected of the patient, and also memorialized the patient's informed consent to the treatment she was requesting from the Respondent. The Respondent also conducted a brief physical examination of the make-believe patient and made written notes that purported to be a memorialization of what he had observed during the course of his examination. The Respondent's examination of the make-believe drug-seeker included the following: check of pulse and blood pressure, check of reflex responses at several joints, and check of chest sounds with stethoscope.

17. The Respondent performed a deep tendon reflex test on Detective Coffin by striking her wrists, elbows, and knees with a medical hammer. Detective Coffin's feet remained on the floor during this test. A deep tendon reflex test cannot be performed

    properly with the subject's feet touching the floor. Such a test performed in such a manner will not produce reliable results.

18. The Respondent indicated in his written notes that he had examined Detective Coffin's head, eyes, ears, nose, and throat. However, the Respondent did not perform any examination at all of Detective Coffin's head, ears, nose, or throat. The Respondent perhaps performed a partial examination of Detective Coffin's eyes, but did not perform an adequate examination of her eyes.

19. The Respondent indicated in his written notes that Detective Coffin's pupils were equal, round, and reactive to light and accommodation. However, the Respondent did not conduct any examination of Detective Coffin's eyes that was sufficient to support a conclusion that they were equal, round, and reactive to light and accommodation.

20. The Respondent included in his written notes that Detective Coffin's chest and lungs were clear to auscultation and percussion. The Respondent did not examine Detective Coffin in a manner that could determine whether her chest and lungs were clear to auscultation and percussion. Therefore, the Respondent did not have any basis for writing that the detective's chest and lungs were clear to auscultation and percussion.

21. The Respondent included in his written notes an observation that Detective Coffin's abdomen was soft. The Respondent never touched or otherwise examined Detective Coffin's abdomen. The Respondent had no factual basis for writing that Detective Coffin's abdomen was soft.

22. In his written notes the Respondent indicated that Detective Coffin experienced pain upon lifting her leg thirty degrees. Detective Coffin never raised either leg in the Respondent's presence and never complained of pain in his presence. There was no factual basis for the subject notation.

23. The Respondent never conducted a Rhomberg examination on Detective Coffin, but he included in his written notes an observation that a Rhomberg test was negative. There was no factual basis for such a notation.

24. The Respondent included in his written notes an observation that he had examined Detective Coffin's gait. However, the Respondent never performed an adequate and sufficient examination of Detective Coffin's gait.

25. The Respondent did not conduct a range of motion test of Detective Coffin. The Respondent never asked Detective Coffin to lift her leg towards her chest. Nor did he ask her to touch her toes. The Respondent never asked her to manipulate her body in any way.

26. At no time during the encounter between Detective Coffin and the Respondent did Detective Coffin state that she was experiencing pain. At no time during that encounter did she behave or move in any manner that would suggest she was experiencing pain. To the contrary, Detective Coffin crossed and uncrossed her legs, alternatively slouched and sat up straight in her chair, and made other movements that would indicate to a reasonable prudent physician that she was not experiencing any pain at all.

27. The Respondent never discussed with Detective Coffin the necessity of obtaining further MRIs, X-rays, or other forms of diagnostic testing. He never discussed any need to obtain and review any prior medical records. The Respondent never asked Detective Coffin to sign a medical records release document that would have authorized the Respondent to obtain prior medical records.

28. The Respondent's written notations regarding his examination of the make-believe drug-seeker contain false information because, among other things, the notations contain the results of tests and examinations the Respondent did not perform. Such false notations are intentional falsehoods.

29. The Respondent never discussed with Detective Coffin the need for a follow-up appointment. The Respondent never asked Detective Coffin for any form of identification.

30. Under the circumstances presented in this case, a reasonable prudent physician would have performed a range of motion test and a leg-raising test, neither of which were performed by the Respondent. Under the circumstances presented in this case, a reasonably prudent physician would have established a treatment plan that would have included a schedule for follow-up visits, a review of prior medical records, and plans for future diagnostic tests. The Respondent did not establish any type of treatment plan.

31. The prescription provided to Detective Coffin was inappropriate, unjustified, and excessive because the physical examination was inadequate, the medical record was falsified, and the patient never exhibited any sign of being in pain.

32. Under the circumstances presented in this case, the Respondent's act of providing a prescription to a total stranger with no medical justification for doing so was an action taken other than in the course of the Respondent's professional practice.

33. Ultimately, the Respondent wrote and delivered a prescription to the make-believe patient. The prescription was for sixty-two 80-milligram tablets of OxyContin. This was a 31- day supply if the OxyContin was taken as directed; one tablet every 12 hours. The Respondent wrote several warnings at the bottom of the prescription document. The warnings included such

    things as the fact that OxyContin impairs driving ability and may cause drowsiness, loss of balance, and/or loss of coordination. The Respondent also wrote on the prescription: "Must swallow whole and do not crush or break."

34. Other law enforcement officers of the HPD were listening to and observing the events inside the room. Shortly after the Respondent handed the prescription to the make-believe patient and received the one hundred dollars from her, other law enforcement officers rushed into the room, arrested the Respondent, and seized various items of the Respondent's personal property, including the medical record he had been preparing regarding his care and treatment of the make-believe patient.

35. With regard to obtaining information about the characteristics of, and the proper use of, specific drugs, medical doctors customarily rely on the information contained in the Physician Desk Reference (PDR) and on the information contained in the manufacturer's package insert that often accompanies a drug. The package insert for OxyContin includes the following information:

    (Following an initial caption reading WARNING)

    
    

    OxyContin Tablets are a controlled-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-

    clock analgesic is needed for an extended period of time.

    
    

    * * *

    
    

    (Following caption reading CLINICAL PHARMACOLOGY)

    
    

    Oxycodone is a pure agonist opioid whose principal therapeutic action is analgesia.

    *** With pure opioid agonist analgesics, there is no defined maximum dose; the ceiling to analgesic effectiveness is imposed only by side effects, the more serious of which may include somnolence and respiratory depression.

    
    

    * * *

    
    

    As with all opioids, the minimum effective plasma concentration for analgesia will vary widely among patients, especially among patients who have been previously treated with potent agonist opioids. As a result, patients must be treated with individualized titration of dosage to the desired effect.

    The minimum effective analgesic concentration of oxycodone for any individual patient may increase over time due to an increase in pain, the development of a new pain syndrome and/or the development of analgesic tolerance.

    * * * OxyContin Tablets are associated with

    typical opioid-related adverse experiences. There is a general relationship between increasing oxycodone plasma concentration and increasing frequency of dose-related opioid adverse experiences such as nausea, vomiting, CNS effects, and respiratory depression. In opioid-tolerant patients, the situation is altered by the development of tolerance to opioid-related side effects, and the relationship is not clinically relevant. As with all opioids, the dose

    must be individualized . . . because the effective analgesic dose for some patients will be too high to be tolerated by other patients.

    
    

    (Following caption reading WARNINGS)

    
    

    OxyContin 80 mg and 160 mg Tablets ARE FOR USE IN OPIOID-TOLERANT PATIENTS ONLY. These

    tablet strengths may cause fatal respiratory depression when administered to patients not previously exposed to opioids.

    
    

    * * *

    
    

    Concerns about abuse, addiction, and diversion should not prevent the proper management of pain. The development of addiction to opioid analgesics in properly managed patients with pain has been reported to be rare. However, data are not available to establish the true incidence of addiction in chronic pain patients.

    
    

    CONCLUSIONS OF LAW

    
    

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

37. Section 458.305(3), Florida Statutes, contains the following statutory definition: "'Practice of medicine' means the diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or other physical or mental condition."

38. Section 458.326, Florida Statutes, reads as follows, in pertinent part:

    1. For the purposes of this section, the term "intractable pain" means pain for which, in the generally accepted course of medical practice, the cause cannot be removed and otherwise treated.

    2. Intractable pain must be diagnosed by a physician licensed under this chapter and qualified by experience to render such diagnosis.

    3. Notwithstanding any other provision of law, a physician may prescribe or administer any controlled substance under Schedules II- V, as provided for in s. 893.03, to a person for the treatment of intractable pain, provided the physician does so in accordance with that level of care, skill, and treatment recognized by a reasonably prudent physician under similar conditions and circumstances.

       
       

39. The rule-based standards for the use of controlled substances for the treatment of pain are found at Florida Administrative Code Rule 64B8-9.013. The standards in that rule include the following pertinent provisions:

    1. Standards. The Board has adopted the following standards for the use of controlled substances for pain control:

       1. Evaluation of the Patient. A complete medical history and physical examination must be conducted and documented in the medical record. The medical record should document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also should document the presence of one or more recognized medical indications for the use of a controlled substance.

       2. Treatment Plan. The written treatment plan should state objectives that will be used to determine treatment success,

          such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.

       3. Informed Consent and Agreement for Treatment. The physician should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient, or with the patient’s surrogate or guardian if the patient is incompetent. The patient should receive prescriptions from one physician and one pharmacy where possible. If the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the physician should employ the use of a written agreement between physician and patient outlining patient responsibilities, including, but not limited to:

          1. Urine/serum medication levels screening when requested;

          2. Number and frequency of all prescription refills; and

          3. Reasons for which drug therapy may be discontinued (i.e., violation of agreement).

       4. Periodic Review. At reasonable intervals based on the individual circumstances of the patient, the physician should review the course of treatment and any new information about the etiology of the pain. Continuation or modification of therapy should depend on the physician’s evaluation of the patient’s progress. If treatment goals are not being achieved, despite medication adjustments, the physician should reevaluate the appropriateness of continued treatment. The physician should monitor patient compliance

          in medication usage and related treatment plans.

       5. Consultation. The physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those pain patients who are at risk for misusing their medications and those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder requires extra care, monitoring, and documentation, and may require consultation with or referral to an expert in the management of such patients.

       6. Medical Records. The physician is required to keep accurate and complete records to include, but not be limited to:

    1. The medical history and physical examination, including history of drug abuse or dependence, as appropriate;

    2. Diagnostic, therapeutic, and laboratory results;

    3. Evaluations and consultations;

    4. Treatment objectives;

    5. Discussion of risks and benefits;

    6. Treatments;

    7. Medications (including date, type, dosage, and quantity prescribed);

    8. Instructions and agreements; and

    9. Periodic reviews. Records must remain current and be maintained in an accessible manner and readily available for review.

    
    

40. Where the revocation or suspension of the physician's license is sought, proof greater than a mere preponderance of the evidence must be submitted before the Board of Medicine (Board) may take punitive action against a licensed physician. Clear and convincing evidence of the physician's guilt is required. § 458.331(3), Fla. Stat. See also Department of

    Banking and Finance, Division of Securities and Investor Protection v. Osborne Stern and Company, 670 So. 2d 932, 935 (Fla. 1996); Ferris v. Turlington, 510 So. 2d 292 (Fla. 1987);

    McKinney v. Castor, 667 So. 2d 387, 388 (Fla. 1st DCA 1995);

    
    

    Tenbroeck v. Castor, 640 So. 2d 164, 167 (Fla. 1st DCA 1994); Nair v. Department of Business and Professional Regulation, 654 So. 2d 205, 207 (Fla. 1st DCA 1995); Pic N' Save v. Department of Business Regulation, 601 So. 2d 245 (Fla. 1st DCA 1992); Munch v. Department of Professional Regulation, 592 So. 2d 1136 (Fla. 1st DCA 1992); Newberry v. Florida Department of Law

    Enforcement, 585 So. 2d 500 (Fla. 3d DCA 1991); Pascale v. Department of Insurance, 525 So. 2d 922 (Fla. 3d DCA 1988);

    § 458.331(3), Fla. Stat.; § 120.57(1)(h), Fla. Stat. ("Findings of fact shall be based on a preponderance of the evidence, except in penal or licensure disciplinary proceedings or except as otherwise provided by statute.").

41. "'[C]lear 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 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 a firm belief or conviction, without hesitancy, as to the truth of the allegations sought to be established.'" In re Davey, 645

    So. 2d 398, 404 (Fla. 1994), quoting, with approval, from Slomowitz v. Walker, 429 So. 2d 797, 800 (Fla. 4th DCA 1983).

42. When the Board seeks to take punitive action against a physician, such action may be based only upon those offenses specifically alleged in the administrative complaint. See Cottrill v. Department of Insurance, 685 So. 2d 1371, 1372 (Fla. 1st DCA 1996); Chrysler v. Department of Professional Regulation, 627 So. 2d 31 (Fla. 1st DCA 1993); Klein v. Department of Business and Professional Regulation, 625 So. 2d 1237, 1238-39 (Fla. 2d DCA 1993); Arpayoglou v. Department of

    Professional Regulation, 603 So. 2d 8 (Fla. 1st DCA 1992); Willner v. Department of Professional Regulation, Board of Medicine, 563 So. 2d 805, 806 (Fla. 1st DCA 1992); Celaya v. Department of Professional Regulation, Board of Medicine, 560 So. 2d 383, 384 (Fla. 3d DCA 1990); Kinney v. Department of State, 501 So. 2d 129, 133 (Fla. 5th DCA 1987); Sternberg v.

    Department of Professional Regulation, 465 So. 2d 1324, 1325 (Fla. 1st DCA 1985); Hunter v. Department of Professional

    Regulation, 458 So. 2d 842, 844 (Fla. 2d DCA 1984).

    
    

43. Furthermore, in determining whether Section 458.331(1), Florida Statutes, has been violated in the manner charged in the administrative complaint, one "must bear in mind that it is, in effect, a penal statute. . . . This being true the statute must be strictly construed and no conduct is to be

    regarded as included within it that is not reasonably proscribed by it. Furthermore, if there are any ambiguities included such must be construed in favor of the . . . licensee." Lester v.

    Department of Professional and Occupational Regulations, 348 So. 2d 923, 925 (Fla. 1st DCA 1977).

44. By operation of legislation enacted during the 2003 session of the Florida Legislature, effective September 15, 2003, Section 456.073(5), Florida Statutes, was amended to read as follows, in pertinent part:

    1. A formal hearing before an administrative law judge from the Division of Administrative Hearings shall be held pursuant to chapter 120 if there are any disputed issues of material fact. The determination of whether or not a licensee has violated the laws and rules regulating the profession, including a determination of the reasonable standard of care, is a conclusion of law to be determined by the board, or department when there is no board, and is not a finding of fact to be determined by an administrative law judge. The administrative law judge shall issue a recommended order pursuant to chapter 120.

       
       

45. There does not yet appear to be any decisional guidance from any of the Florida appellate courts, as to what extent, if any, the above-quoted amendment requires any changes in the manner in which hearings before the Division of Administrative Hearings should be conducted, or requires any changes in the content of the recommended orders prepared by the DOAH administrative law judges. By their conduct at hearing

    both parties seemed to be of the view that the above-quoted statutory amendments did not change the nature of the evidence to be offered in cases of this nature, because both parties requested, and were granted, the opportunity to offer expert witness testimony on the subject matter of whether Respondent "has violated the laws and rules regulating the profession," as well as on the subject matter of what constitutes the "reasonable standard of care."

46. The Proposed Recommended Orders submitted by the parties do not suggest that the above-quoted statutory language requires any changes to the nature of the content that has customarily been included in recommended orders in cases of this nature. The current language of Section 456.073(5), Florida Statutes, is sufficiently broad for it to be interpreted and applied in more than one way. And some of the possible interpretations and applications might at some future date provide a basis for modification of the manner in which administrative hearings in such cases are conducted. But such possible interpretations and applications are merely possibilities; they are not certainties. Therefore, unless and until there is some authoritative interpretation or implementation of the subject amendments directing otherwise, the most prudent course appears to be for the DOAH administrative law judges to continue to receive evidence and to

    continue to make "determinations" (by findings of fact or by conclusions of law) as to what constitutes the "reasonable standard of care" and as to whether a licensee "has violated the laws and rules regulating the profession."7

47. Count One of the Administrative Complaint alleges that the Respondent violated Section 458.331(1)(t), Florida Statutes. At all times material, Section 458.331(1)(t), Florida Statutes, described the following conduct for which the Board could take disciplinary action against a licensed physician:

    (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 conditions and circumstances. The board shall give great weight to the provisions of s. 766.102 when enforcing this paragraph.

    
    

48. The language quoted immediately above describes the statutory standard of care that must be met by all physicians licensed to practice in Florida ("the required standard of care"). It is clear from the foregoing findings of fact that in his interactions with Detective Coffin during the evening of January 20-21, 2005, the Respondent departed from or failed to meet the required standard of care described at Section 458.331(1)(t), Florida Statutes. His departures and failures in that regard include his failure to conduct and document a complete medical examination prior to prescribing OxyContin, a

    Schedule II controlled substance, as well as his prescription of OcyContin without adequate medical justification. Under the factual circumstances proved here, no reasonably prudent physician would have prescribed sixty-two 80-milligram tablets of OxyContin. Such being the case, the Respondent's conduct would appear to be in violation of Section 458.331(1)(t), Florida Statutes. However, the undersigned is of the view that the act of prescribing a controlled substance for improper purposes or improper reasons is an act that is "other than in the course of the physician's professional practice." And inasmuch as such an act is outside the scope of the practice of medicine, Section 458.331(1)(t), Florida Statutes, does not appear to apply to such an act because, by its terms, Section 458.331(1)(t) appears to be limited in application to acts performed in the course of the practice of medicine.

    Accordingly, the undersigned is of the view that the Respondent's actions at issue here did not violate Section 458.331(1)(t). The reasoning underlying this conclusion is set forth in greater detail regarding the application of similar facts to Section 458.331(1)(m), Florida Statutes, in the recommended orders in Department of Professional Regulation, Board of Medicine v. James H. Sternberg, M.D., DOAH Case No. 91- 5044 (Recommended Order issued January 20, 1993), and Department of Professional Regulation, Board of Medicine v. Asher S. A.

    Padeh, M.D., DOAH Case No. 93-0117 (Recommended Order issued June 28, 1994). Consistent with the foregoing, the undersigned is of the view that Count One of the Administrative Complaint should be dismissed.

49. Count Two of the Administrative Complaint alleges that the Respondent violated Section 458.331(1)(m), Florida Statutes, "by failing to keep and maintain appropriate medical records that justify the course of treatment of the patient." At all times material, Section 458.331(1)(m) has described the following conduct for which the Board could take disciplinary action against a licensed physician:

    (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.

    
    

50. The rule-based medical records standards required by Section 458.331(1)(m), Florida Statutes, are found at Florida Administrative Code Rule 64B8-9.003. The standards in that rule include the following pertinent provisions:

    1. A licensed physician shall maintain patient medical records in English, in a legible manner and with sufficient detail to clearly demonstrate why the course of treatment was undertaken or why an apparently indicated course of treatment was not undertaken.

    2. The medical record shall contain sufficient information to identify the patient, support the diagnosis, justify the treatment and document the course and results of treatment accurately, by including, at a minimum, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; reports of consultations and hospitalizations; and copies of records or reports or other documentation obtained from other health care practitioners at the request of the physician and relied upon by the physician in determining the appropriate treatment of the patient.

    
    

51. It is clear from the findings of fact that the Respondent's written records regarding his interactions with Detective Coffin during the evening of January 20-21, 2005, are insufficient because they do not contain sufficient information to identify the patient, do not contain sufficient information to support a diagnosis, and do not contain sufficient information to justify the prescription for OxyContin the Respondent provided to Detective Coffin. Worse yet, the Respondent's written records of the subject encounter contain false and fraudulent information which was intentionally placed in the records by the Respondent for the purpose of attempting to create the illusion that there was a sufficient basis for the

    prescription he wrote that night. The records include fake history that was never given by Detective Coffin and also includes fake results of tests and examinations that were never performed. Such being the case, the Respondent's written records would appear to be in violation of Section 458.331(1)(m), Florida Statutes. However, for reasons similar to those discussed above regarding Section 458.331(1)(t), the undersigned is of the view that the record-keeping requirements of Section 458.331(1)(m) are applicable only when a patient is being treated. Here there was no bona fide effort to provide medical treatment to a patient; only an effort to receive money for writing a prescription for which there was no medical justification. Accordingly, the undersigned is of the view that the record-keeping requirements do not apply to the Respondent's conduct in this case. Consistent with the foregoing, the undersigned is of the view that Count Two of the Administrative Complaint should be dismissed.8

52. Count Three of the Administrative Complaint alleges that the Respondent violated Section 458.331(1)(q), Florida Statutes. At all times material to this case, Section 458.331(1)(q), Florida Statutes, has described the following conduct for which the Board could take disciplinary action against a licensed physician:

    (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.

    
    

53. The Board's interpretation of Section 458.331(1)(q), Florida Statutes, has recently been in somewhat of a state of flux as a result of a series of cases in which the Board first adopted, and then rejected, and then most recently appears to have re-adopted, an interpretation of Section 458.331(1)(q), Florida Statutes, which was first described in the Recommended Order in Department of Health, Board of Medicine v. Leland M. Heller, M.D., DOAH Case No. 00-4747PL, 2001 WL 666972. It is not clear at this time whether the Board has re-adopted the interpretation set forth in Heller or whether the Board's interpretation of Section 458.331(1)(q), Florida Statutes, is still as described in the Final Orders in Department of Health, Board of Medicine v. Anthony Glenn Rogers, M.D., DOAH Case

    No. 02-0080PL (Recommended Order issued February 21, 2003; Final Order issued February 17, 2004), and Department of Health, Board

    of Medicine v. Jerome F. Waters, M.D., DOAH Case Nos. 04-0400PL, 04-0401PL, and 04-0869PL (Recommended Order issued August 30, 2005; Final Order issued October 18, 2005). But this uncertainty is of no significance to the disposition of this case, because under either interpretation of Section 458.331(1)(q), Florida Statutes, the disposition of Count Three would be the same.

54. There is clear and convincing evidence in this case that the Respondent's interaction with Detective Coffin during the evening of January 20-21, 2005, was for the purpose of, for monetary profit, providing the make-believe drug-seeker with a prescription for a controlled substance to satisfy the drug- seeker's craving for the drug she sought. In other words, the Respondent set out in the middle of the night to sell a prescription for OxyContin to a total stranger who had no bona fide medical reason for receiving the prescription. The interaction that evening was not for the purpose of "the diagnosis, treatment, operation, or prescription for any human disease, pain, injury, deformity, or other physical or mental condition." Because the interaction was not for any of the quoted purposes, the interaction did not constitute the "practice of medicine" as defined at Section 458.305(3), Florida Statutes. Because the interaction between Detective Coffin and the Respondent did not constitute the "practice of medicine,"

    that interaction was "other than in the course of the physician's professional practice." The act of providing a prescription for a Schedule II controlled substance "other than in the course of the physician's professional practice" is a clear violation of Section 458.331(1)(q), Florida Statutes, because by providing such a prescription under the circumstances proved in this case, the Respondent is guilty of "[p]rescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in the course of the physician's professional practice." (Emphasis added.)9

55. The violation in this case is especially egregious and reprehensible because it involves the prescription of a Schedule II controlled substance to a total stranger for no legitimate reason. The legal, moral, and ethical shortcomings implicit in the conduct proved in this case are similar to those implicit in the conduct proved in Department of Professional Regulation, Board of Medical Examiners v. Richard English, M.D., DOAH Case No. 80-309 (Recommended Order issued June 20, 1980). In English the hearing officer wrote:

    33. From the foregoing it is concluded that Respondent dispensed Class II controlled substances . . . not in the course of Respondent's professional practice. It is further concluded that this is not a slight abuse of the authority of a physician to issue a prescription improperly but

    constitutes an out-and-out engagement by Respondent in the distribution and sale of dangerous drugs in total disregard of the dangers inherent in such distribution.

    
    

56. Conduct of the type proved in this case is a serious abuse of a physician's prescription-writing authority and presents a serious danger to the public at large. Therefore, such conduct warrants a severe penalty. Nothing short of license revocation appears to be sufficient to protect the public.

RECOMMENDATION

On the basis of the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be issued in this case to the following effect:

1. Dismissing Counts One and Two of the Administrative Complaint;

2. Concluding that the Respondent is guilty of having violated Section 458.331(1)(q), Florida Statutes, as charged in Count Three of the Administrative Complaint; and

3. Imposing a penalty consisting of an administrative fine in the amount of ten thousand dollars ($10,000.00) and the revocation of the Respondent's license to practice medicine.

DONE AND ENTERED this 26th day of June, 2006, 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 26th day of June, 2006.

ENDNOTES

1/ Unless otherwise indicated, all references to the Florida Statutes are to the 2004 version of those statutes.

2/ Petitioner Exhibits 1 and 2 were marked for identification and then withdrawn without being offered. Petitioner Exhibits 3, 4, 5, 7, and 8 were received in evidence. Objections were sustained to Petitioner Exhibits 6 and 9.

3/ Respondent Exhibits 1 and 3 were marked for identification, but were not offered in evidence. Respondent Exhibits 2, 4, 5, 6, 7, 8, 10, 11, 12, 13, 14, and 15 were received in evidence. Objection was sustained to Respondent Exhibit 9.

4/ The matters officially recognized include copies of the following materials:

1. Section 20.43, Florida Statutes (2004)

2. Section 458.326, Florida Statutes (2004)

3. Section 458.331, Florida Statutes (2004)

4. Section 817.50, Florida Statutes (2004)

5. Florida Administrative Code Rule 64B8-8.001

6. Florida Administrative Code Rule 64B8-9.003

7. Seven pages of information comprising package insert information for Oxycontin.

8. Guidelines issued by the Florida Board of Medicine, Board of Osteopathic Medicine, and Agency for Health Care Administration for management of pain using dangerous drugs and controlled substances.

9. Model Policy for the Use of Controlled Substances for the Treatment of Pain issued by the Federation of State Medical Boards of the United States.

5/ The Respondent has not practiced medicine in the State of Florida since some time in early 2005 when an emergency suspension order was issued which suspended the Respondent's license to practice medicine in Florida pending disposition of this case.

6/ In the detective's own words: "Basically, if he was asking me a question, I was saying yes." (Transcript, page 223.) In this regard it is also significant to note that Detective Coffin did not make up most of the details of the story the Respondent intended to use as the "medical reason." Rather, the Respondent made up most of the story with his leading questions and for the most part Detective Coffin simply agreed with his imaginary story.

7/ Some of the "determinations" as to whether Respondent "has violated the laws and rules regulating the profession" are located in the findings of fact portion of this Recommended Order, and other such "determinations" are located in the Conclusions of Law. The ALJ has tried to place such "determinations" where he believes they belong, taking into consideration both a long history of appellate court guidance on such matters and the current language of Section 456.073(5), Florida Statutes. In any event, the placement of such determinations in one part of the Recommended Order or the other does not appear to be of any great moment, because it is reasonable to expect that the appellate courts will continue to be of the view that, regardless of where placed and regardless of how characterized, a fact will always be a fact and a conclusion of law will always be a conclusion of law.

8/ In its Final Orders in the Sternberg and Padeh cases the Board disagreed with the legal analysis which underlies the recommended disposition of Counts One and Two of the Administrative Complaint in this case. If the Board should continue to be of the view that paragraphs (m) and (t) of

Section 458.331(1) can be violated by conduct that does not constitute the practice of medicine, then the Board's disposition of Counts One and Two should, of course, be different from what is recommended here.

9/ Clear and convincing evidence in this case also supports a finding that the prescription the Respondent provided to Detective Coffin was "in excessive or inappropriate quantities." Such facts give rise to the legal presumption expressed in the last sentence of paragraph (q) of Section 458.331(1), Florida Statutes, to the effect that the subject prescription "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."

COPIES FURNISHED:

William F. Miller, Esquire Ephraim D. Livingston, Esquire Department of Health Prosecution Services Unit

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

Donald A. Tobkin, M.D. Post Office Box 220990

Hollywood, Florida 33022-0990

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. M. Rony François, Secretary 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 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: 05-002590PL

Orders for Case No: 05-002590PL