Received Event (Event Succeeded) " Date: . 6/14/00 a Time: > 4:53 PM Pages: 1 W Pee Sender: Ww Remote CSIB.14.2a2@ 4:57PM AHCA/MEDICAL . NO. 356 P.a/11> - a a STATE OF FLORIDA DEPARTMENT OF HEALTH . DEPARTMENT OF HEALTH, 'y OD -248 PETITIONER, ) | ) v ) CASE NO. 97-11305 ; ) BENITO R. LAGO, M.D., ) | ' ) . RESPONDENT. ) ADMINIS uN COMPLAINT. COMES NOW the Petitioner, Department of Health, hereinafter referred to as “Petitioner,” and files this Administrative Complaint before the Board of Medicine against Benito R. Lago, 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 455, 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 i is and has been at all times material hereto 2 a licensed physician in the state of Florida, having been issued license numiber ME 0044913. Respondent's last known address is 13985 sw 20% Street, Miami, Florida 33175. 3. Respondent specializes in weight loss medicine, and is not board certified in any specialty area. Received Event (Event Succeeded) " Date: 6/14/00 ; te Time: 4 4:53 PM _ Pages: 11 ad i” . Sender: v ‘Remote CSIR; 14.2022 94:58PM = AHCA/MEDICAL NO.356 =P. 4/14 i : ne 4, On or about June 27, 1996, during a routine inspection of Respondent's dispensing practice, an investigator for Petitioner found several bottles containing approximately one thousand (1,000) tablets of thyroid medication, in both ong (1) and two (2) grain dosages, Inspection of Respondent’s prescription records revealed’ numerous prescriptions for thyrdid medication. Respondent stated that he had used thyroid medications in the past to wean patients already being treated for obesity in this manner, but no longer used thyroid medication for weight loss purposes. 5. In or about June, 1997, a second routine inspection of Respondent’s dispensing practice was conducted, and further evidence of Respondent's current use of thyroid medication for weight loss was discovered. On or about June 23,1997, Respondent was served with an Agency subpoena requesting the names and addresses of all patients treated with thyroid medication between on or about January 1, 1993, and on or about June 23, 1997. 6. In or about August 1997, Respondent provided a list of approximately two thousand five hundred (2,500) names of patients in response to the subpoena described above. Petitioner then issued a subpoena requesting the medical records of 24 randomly selected patients for review. 7. Rule 64B-10.002, Florida Administrative Code, provides, in pertinent part; (3) A licensed physician shall keep adequate written medical records, as required by Section 458.331(1)(m), Florida Statutes, for a period of five years from the last patient contact. 8 Among the patient medical records requested were the records of Patient D,Y. In or about October 1997, Respondent stated he was unable to locate Patient D.Y.’s medical © Tecords, Received Event (Event Succeeded) " Date: os ime: \ 4:53 PM Date: 6/14/00 w : Time w Pages: 1 : . Sender: Remote CSIAi14.2208' 4:58PM = AHCA/MEDICAL NO.356 " P.S/11 _ . i cone) 9, On or about October 14, 1997, Respondent provided patient medical records for 23 of the 24 requested medical records. Respondent's medical records for Patient D.Y. were never located. : : | 10. " Patient J.S., a 56 year old overweight male, presented to Respondent between on or about October 31, 1995 through June 27, 1997. On numerous and diverse occasions during this period, Respondent prescribed thyroid medication to Pateat TS despite pre-treatment laboratory studies indicating normal thyroid faction, 11, Patient M.Z., a 30 year old overweight female, presented to Respondent between on or about March 7, 1994 through May 14, 1996. Respondent prescribed thyroid medication to Patient M.Z., despite pre-treatment laboratory studies indicating normal thyroid function. 12. Patient Y.M., a 44 year old overweight female, presented to Respondent between on or about November 16, 1995 through June 14, 1996. Respondent prescribed thyroid medication to Patient Y.M., despite pre-treatment laboratory stidies indicating normal thyroid function, 13, Patient AJ., a 44-year-old overweight female, presented to Respondent between on or about April 20, 1995 through August 19, 1996. Respondent prescribed thyroid medication to Patient A.J., despite pre-treatment laboratory studies indicating normal thyroid fimetion, 14. Patient PT. a 29-year-old overweight male, presented to Respondent between on or about February 9, 1993, through July 2, 1996, Respondent prescribed thyroid medication to Patient P.T. » despite pre-treatment laboratory studies indicating normal thyroid function. 15. Patient L G,, a 26-year-old overweight female, presented to Respondent between on or about October 28, 1994 through April 22, 1996. Respondent prescribed thyroid medication to Patient J.G., despite pre-treatment laboratory studies indicating normal thyroid function. Received Event (Event Succeeded) Date: 6/14/00 iw) 7 te Time: i) 4:53 PM Pages: 11 : . Sender: Remote CSIBi 14.2088 84:58PM AHCAVMEDICAL NO.356 «-'P.6711 _ ne 16. Patient L.W., a 26-year-old overweight female, presented to Respondent between on or about January 3, 1994, through June 19, 1997. Respondeht prescrihed thyroid medication to Patient L.W., despite pre-treatment laboratory studies indicating normal thyroid function. “47. Patient HLH., a 46-year-old overweight female, presented to Respondent between on or about February 17, 1994 through September 19, 1995. Respondent prescribed thyroid medication to Patient H.H., despite pre-treatment laboratory shies indicating normal thyroid function. , 18. Patient C.G., a 41-year-old overweight female, presented to Respondent between on or about March 10, 1994 through November 29, 1996. Respondent prescribed thyroid medication to Patient C.G., despite pre-treatment laboratory studies indicating normal thyroid function, 19.“ Patient TA, a 33-year-old overweight female, presented to Respondent between on or about February 22, 1994, through May 13, 1996. iRespondent prescribed thyroid " medication to Patient LA. despite pre-treatment laboratory studies indicating normal thyroid function. 20. Patient W.E., a 32-year-old overweight female, presented ta Respondent between on or about February 22, 1994, through May 13, 1996. Respondent prescribed thyroid medication to Patient W-E., despite pre-treatment lsboratory studies indicating normel thyroid function. / ‘Patient c. cy a 27-year-old overweight female, presented to Respondent between on or about March 28, 1993, through April 23, 1996. Respondent prescribed thyroid medication to Patient C.C., despite pre-treatment laboratory studies indicating normal thyroid function. Received Event (Event Succeeded) Date: 6/14/00 ws Time: uy 453 PM Pages: a od o . Sender: Remote CSIR; 14.2022 4:58PM AHCA/MEDICAL ‘ NO.356 =‘P.7711 . Lo [7 — ee 22, Patient M.B., a 67-year-old overweight female, Presented to Respondent between on or about March 8, 1993 through April 23, 1996. Respondent presoribed thyroid medication to Patient M.B,, despite pre-treatment laboratory studies indicating normal thyroid function. 23, Patient M.A. #1, a 44-year-old overweight feale presented to Respondent between on or about June 10, 1993 through October 25, 1994. Respondent prescribed thyroid medication to Patient M.A.#1, despite pre-treatment laboratory bmudies indicating normal thyroid function. : 24. Patient M.A.#2, a 41-year-old overweight female, presented to Respondent between on or about June 30, 1992 through March 4, 1997. : Respondent presctibed thyroid medication to Patient M.A.#2, despite pre-treatment laboratory studies indicating normal thyroid function. 25. Patient R.Y., a 38-year-old overweight female, presented to Respondent between ” \ on or about January 19, 1989, through July 24, 1995. Respondent prescribed thyroid medication to Patient R.Y., despite pre-treatment laboratory studies indicating normal thyroid function. 26. Patient R.C., a 54-year-old overweight female, presented to Respondent between on or about February 1 1, 1993 through April 4, 1994, Respondent prescribed thyroid medication to Patient RC, despite pre-treatment Inborafory studies indicating normal thyroid function. _2F. Patient M. 5, a 48-year-old overweight male, presented | to Respondent between on or about February li, 1993, through April 4, 1994, Respondent prescribed thyroid medication to: Patient MS, despite pre-treatment laboratory studies indicating normal thyroid function. 28. ‘Patient D.G., a 29-year-old overweight male, presented to Respondent between on or about January 16, 1995 through June 9, 1997, Respondent prescribed thyroid medication to Patient D.G., despite pre-treatment laboratory studies indicating normal thyroid function, Received Event (Event Succeeded) ” Date: 6/14/00 +e Time: ~ 9 4:53 PM Pages: 1 ad a a Sender: ed Remote CSIB;14.2@20 4:59PM AHCA/ MEDICAL ’ NO. 356 P.8744 —_ Pee 29. Patient M.Z., a 49-year-old overweight female, piesented to Respondent between on or about September 23, 1994, through December 12, 1994, Respondent prescribed thyroid medication to Patient M.Z., despite pre-treatment laboratory studies indicating normal thyroid function. . 30. Patient M.A.#3, a 33-year-old overweight female, presented to Respondent between on or about January 3, 1995, through November 22! 1996. Respondent prescribed thyroid medication to Patient M.A.#3, despite pre-treatment laboratory studies indleating normal thyroid function. 31. Patient H.T., a 48-year-old overweight female, presented to Respondent between on or about April 7, 1994 through October 6, 1997. Respondent prescribed thyroid medication to Patient HL.T., despite pre-treatment laboratory studies indicating normal thyroid function. 32. Patient M.A.#4, a 46-year-old overweight female, presented to Respondent between on or about March 3, 1992, through December 10, 1993, Respondent prescribed thyroid medication to Patient M.A.#2, despite pre-treatment laboratory studies indicating normal thyroid function, 33. ‘Respondent failed to keep written medical records justifying the course of treatment of the aforementioned patients, in that Respondent maintains no medical records for Patient D.Y., and his medical records for the remaining 23 patients described above do not justify the presoription of thyroid medication, in that these patients exhibited normal thyroid function prior to treatment. 34, Thyroid hormone replacement medications are legend drugs as defined by Section 465.003(7), Florida Statutes, and are indicated for the treatment of patients with abnormal thyroid function, particularly those with lowered levels of thyroid hormones (hypothyroid), Received Event (Event Succeeded) : Date: 6/14/00 tod ee Time: 9 4:53 PM Pages: 1 a Sender: Remote CSUR. 14.2220 94:59PM = AHCAYMEDICAL NO.356° P9714 _ be Thyroid hormones should not be used to treat obesity, and their use in patients with normal thyroid function (enthyroid) in inappropriate or large doses or in combination with anorectic drugs can produce serious, life threatening side effects. 35. Respondent inappropriately prescribed tevend ‘drugs, in that Respondent prescribed thyroid replacement medication to the 23 euthyroid patients listed above, and improperly did so to treat these patients for obesity. | 36. Areasonably prudent similar Physician would not prescribed thyroid replacement medications to treat obesity in any patient, and would not prescribed thyroid replacement medication to any euthyroid patient. COUNT ONE 37. Petitioner realleges and incorporates paragraphs one (1) through thirty-six (36), as if fully set forth herein this Count One, 38. Respondent failed to keep vwritten medical records justifying the course of treatment of the aforementioned patients, in that Respondent miaintains no medical records for Patient D.Y., and his medical records for the remaining 23 patients described herein do not justify the prescription of thyroid medication, in that these patients exhibited normal thyroid function prior to treatment. 39, ‘Based on the foregoing, Respondent violated Section 458. 331(1)(o), Florida Statutes, by 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 ceeemgee samme cpm ep Received Event (Event Succeeded) Date: , 6/44/00 vr Time: & 3) 4:53 PM ~ Pages: 11 Ww. . a Sender: ad Remote CSIP; 14.2028 9 4:59PM = AHCA/MEDICAL NO.356 P1811 See . ~ 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, co TWO 40. Petitioner realleges and incorporates paragraphs lone (1) through thirty-six (36) and paragraph thirty-eight (38) as if fully set forth herein this Count Two, 41. Respondent inappropriately prescribed legend drugs, in that Respondent prescribed thyroid replacement medication to the 23 euthyroid patients listed above, and improperly did so to treat these patients for obesity. 42, Based on the foregoing, Respondent violated Section 458.331(1)(q), Florida Statutes, by prescribing, dispensing, administering, mixing, or otherwise preparing a legend dmg, 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, inelyding all controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and not in the course of the physician’s professional practice, without regard to his intent, COUNT. EB 43. Petitioner tealleges and incorporates paragraphs one (1) through thirty-six (36), thirty-eight (38) and forty-one (41) as if fully set forth herein this Count Three. 10 se seememeereeee eee pees sree pe creme mer met Received Event (Event Succeeded) “Date: «6/14/00 we, i Time: ws 158 PM Pages: 11 ae 7 Sender: Remote CIB: 14.2008 4:59PM AHCA/MEDICAL NO.356 P1414 44. Respondent practiced medicine below the standard of care, in that Respondent improperly prescribed thyroid replacement medications to the 23 patients described herein to treat them for obesity, and when such patients exhibited no thyroid dysfunction or deficiency prior to treatment, : . ‘ : 7 45, Based on the foregoing, Respondent has violated Section 458,331(1 (0, 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. 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, other than costs associated with an attomey’s time, as provided for in Section 455.624(3), Florida Statutes, and/or any other relief that the Board deems appropriate, SIGNED this, QL day of Yoatoh , 1999, : Robett G. Brooks, M.D,, Secretary . SpARTMENT OF HEALTH Lany G. McPhers@a/r, EPA SoTY ou 2: Chief Medical Attorney cemsptip ’ q 11

Docket for Case No: 00-002489