’ STATE OF FLORIDA DEPARTMENT OF HEALTH Sy . ao,” % : ?, x F 5 DEPARTMENT OF HEALTH, ) Wh, 9 co, KCKE Se “a ) an Ko Fr) PETITIONER, ) Vege on ) Oy, v. ) CASE NO. 1997-16632 & RICHARD J. ROSE, M.D., ) ) RESPONDENT. __) le ) . ADMINISTRATIVE COMPLAINT COMES NOW the Petitioner, Department of Health, hereinafter referred to as “Petitioner,” and fiies this Administrative Complaint before the Board of Madicine against Richard J. Rose, M.D., hereinafter referred to as “Respondent,” and alleges: 1. Effective July 1, 1997, Petitioner is the state agency charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes, and Chapter 458, Florida Statutes. Pursuant to the provisions of Section 20.43(3), Florida Statutes, the Petitioner has contracted with the Agency for Health Care Administration to provide consumer complaint, investigative, and prosecutorial services required by the Division of Medical Quality Assurance, councils, or boards, as appropriate. 2. Respondent is and has been at all times material hereto a licensed physician in the state of Florida, having been issued license number ME 0016425. Respondent's last known address is 2999 NE 191% Street, Suite 400, Aventura, FL 33180.. | 3. Respondent is board certified in Ophthalmology. At all times material hereto, he was a dispensing practitioner practicing bariatrics. - 4. On or about July 15, 1995, Patient MJC presented to the Medical Institute for Weight Loss (hereinafter “the clinic”) in Aventura. Patient MJC presented after reading the clinic's advertisements for weight loss treatment in the Miami New Times newspaper. In at least some of those advertisements, Respondent is identified as the Medical Director for the clinic. 5. During her visit to the clinic on or about July 15, 1995, Patient MJC was asked to complete certain documents, including a so-called “weight control questionnaire.” Patient MJC indicated: in her responses that she wished to lose 100 pounds, and that she was interested in using fenfluramine to assist her weight loss. At the time of her initial visit, Patient MJC weighed approximately 287 pounds. Her height was recorded as five feet, six inches. 6. Patient MJC advised in her responses to the questionnaire that she suffered from heart palpitations, and specifically indicated having mitral valve prolapse. The patient further indicated having a family history of cardiovascular illness, as well as a family history of glaucoma. 7. During the patient’s visit of on or about July 15, 1995, Patient MJC specifically informed Respondent that she suffered from mitral valve prolapse, and that she was concerned about taking any drugs which may affect her heart. 8. Respondent requested that Patient MJC undergo certain laboratory tests during the visit of on or about July 15, 1995. The results of these tests were made available to the Respondent on or about July 17, 1995. 9. Respondent’s physical examination record for Patient MJC of on or about July 15, 1995, contains no reference to the patient’s history of heart palpitations and mitral valve prolapse. The heart examination notes “no murmurs,” and “NSR” (normal sinus rhythm). There is no reference to whether the Respondent inquired regarding the patient's reported family history of cardiovascular illness, or whether the patient’s cardiologist was consulted. 10. Respondent prescribed Fastin (phentermine hydrochloride) 30 mg. and Pondimin (fenfluramine hydrochloride) 20 mg. for Patient MIC at her initial visit of on or about July 15, 1995. These combination amounts of Fastin and Pondimin are excessive as a beginning dosage for weight loss purposes. The medication was supplied to her at the Respondent's clinic. 11. Fastin is a legend drug previously used as an adjunct, together with Pondimin, also a legend drug, in the short-term treatment of exogenous obesity. The use of a combination of Fastin and Pondimin has been linked to the development. of Primary Pulmonary Hypertension (PPH), a rare, frequently fatal, disease of the lungs. Valvular Heart Disease, primarily affecting the mitral, aortic, and/or tricuspid valves, has been reported in otherwise healthy patients using a combination of Fastin and Pondimin. Pondimin is contraindicated in patients with glaucoma. 12. Respondent continued to treat Patient MJC with a weight loss regimen, including the use of Fastin and Pondimin, through at least December 1995. Progress notes for the dates of July 29, 1995, August 26, 1995, October 4, 1995, and November 4, 1995, contain no reference to laboratory studies, and include minima! assessments of the patient’s heart and lung function. 13. A progress note dated July 24, 1995, reflects that Patient MJC reported to the clinic that she was experiencing stomach pains, fatigue, diarrhea, and constipation. The note indicates that a decision would be made at the patient's upcoming visit regarding a decrease in her medication dosage. Respondent's medical record thereafter makes no further reference to the patient’s July 24 complaint. 14. On or about November 4, 1995, Respondent suggested that Patient MIC increase her midday dosage of Pondimin from 20 mg. to 40 mg. Patient MIC indicated she was not ready for the increase. On or about December 9, 1995, however, Respondent did increase the midday dosage of Pondimin to 40 mg. 15. Respondent failed to render appropriate care to Patient MJC in that he prescribed the medications Fastin and Pondimin to her prior to obtaining and evaluating results of the laboratory tests which he ordered at the patient's initial visit, and without making an appropriate cardiac assessment of the patient, including, but not limited to, an assessment of the patient’s reports of pre-existing palpitations and mitral valve prolapse, by failing to consult with the patient's cardiologist, and without appropriately assessing the patient's reported family history of cardiac illness, and in that he continued to prescribe these medications to the patient through at least December 1995 without: conducting an appropriate assessment of the patient. 16. Respondent failed to appropriately prescribe to Patient MJC by failing to appropriately assess the patient prior to initially prescribing the combination of Fastin and Pondimin to her, by prescribing a beginning dosage of Fastin and Pondimin which was excessive, and by continuing to prescribe these medications to the patient through at least December 1995 without an appropriate assessment. 17. Respondent failed to prepare an appropriate medical record for Patient MIC by failing to prepare a medical record which justified the course of treatment provided to the patient, including the failure to appropriately document the drugs prescribed and the failure to document an adequate assessment of the patient's complaints and symptoms. COUNT ONE 18. Petitioner realleges and incorporates paragraphs one (1) through seventeen (17), as if fully set forth herein this Count One. 19. Respondent 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 conditions and circumstances, in one or more of the following ) ways: (1) Respondent failed to adequately assess Patient MJC before prescribing the drug combination of Fastin and Pondimin for weight loss, by one or more of the following acts or omissions: (a) Respondent failed to obtain and evaluate results of the laboratory tests which he orderéd at the patient's initial visit prior to prescribing the combination of Fastin and Pondimin to her; (b) Respondent failed to consult with the patient's cardiologist before prescribing the Fastin and Pondimin combination; and (c) Respondent failed to perform an appropriate cardiac assessment of the patient, including, but not limited to, an assessment of the patient’s reports of pre-existing palpitations, mitral valve prolapse, and family history of cardiac illness, prior to prescribing the combination of Fastin and Pondimin to her; and (2) Respondent failed to conduct an appropriate ongoing assessment of the patient while continuing to prescribe the drug combination of Fastin and Pondimin to her through at least December 1995. 20. Based on the foregoing, Respondent has violated Section 458.331(1)(t), Florida Statutes, by failing 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. COUNT TWO 21. Petitioner realleges and incorporates paragraphs one (1) through seventeen (17) and paragraph nineteen (19) as if fully set forth herein this Count Two. 22. Respondent failed to keep a medical record justifying the course of treatment provided to patient MIC, including the failure to appropriately document the drugs prescribed and dispensed to the patient. 23. Based on the foregoing, Respondent violated Section 458.331(1)(m), Florida Statutes (1995), by failing to keep written medical records justifying 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. COUNT THREE 24. Petitioner realleges and incorporates paragraphs (1) through seventeen (17), nineteen (19), and twenty-two (22) as if fully set forth herein this Count Three. 25. Respondent prescribed, dispensed, administered, mixed, or otherwise prepared a legend drug, including any controlled substance, other than in the course of the physician’s professional practice, in that Respondent failed to appropriately prescribe to Patient MIC by failing to appropriately assess the patient prior to prescribing the combination of Fastin and Pondimin to her, by prescribing an excessive dosage of the combination of Fastin and Pondimin, and by thereafter failing to appropriately assess and monitor the patient while prescribing these drugs to her. 26. Based on the foregoing, Respondent violated Section 458.331(1)(q), Florida Statutes, 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. For the purposes of this paragraph, it shall be legally presumed that prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including all controlled substances, inappropriately or in “ps # excessive or inappropriate quantities is not in the best interest of the Refient bb A T.9 p t. M 3, 1, the course of the physician's professional practice, without regard to his ingen &2 WHEREFORE, the Petitioner respectfully requests the Board of Medicine enter an order imposing one or more of the following penalties: permanent revocation or suspension of the Respondent's license, restriction of the Respondent's practice, imposition of an administrative fine, issuance of a reprimand, placement of the Respondent on probation, the assessment of costs related to the investigation and Prosecution of this case as provided for in Section 456.072(4), Florida Statutes, and/or any other relief that the Board deems appropriate. CA SIGNED this_27 "Gay of Sgatlian , 2000. Robert G. Brooks, M.D., Secretary COUNSEL FOR DEPARTMENT: Kathryn L. Kasprzak Chief Medical Attorney Fl LED ENT OF HEALTH Agency for Health Care Administration OEE AEPUTY CLERK P. O. Box 14229 sbi R, Ken Tallahassee, Florida 32317-4229 cuenK ‘obi Re en Florida Bar # 937819 DATE 2§/02 BLT PCP: September 25, 2000 PCP Members: Cerda, McMillin, Varn

Docket for Case No: 00-004179PL