wi an lib i laa dis Alba oc. Received Event (Event Succeeded" . wl Time: 9: ar) ~ Date: ” Pages: le ~ 3/20/00 © 16 Duration: 4 min 8 sec MAR 23. 20a 9:25AM — AHCA-MEDICAL Rotttess es NO.146 P5716 ~ an STATE OF FLORIDA DEPARTMENT OF HEALTH * OO- \ | Q lb DEPARTMENT OF HEALTH, PETITIONER, v. CASE NO. 9615236 KENNETH MICHAEL SEKINE, M.D., Nee ee ee RESPONDENT. ADMINISTRATIVE COMPLAINT COMES NOW the Petitioner, Department of Health, hereinafter referred to as _ “Petitioner,” and files this Administrative Complaint before the Board of Medicine against Kenneth Michael Sekine, 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 | Quali A surance, councils, or t boards, as 's appropriate, 2 Respondent i is end has been at all times material hereto a sense physician i in the ned license umber ME 0030838. Respondents last known . address i is 836 Prudential Drive, #802, Jacksonville FL 32207. 8335. . 3. Respondent area of specialty is gynecology, obstetties, and infertility. Received Event (Event Succeeded’ Date: 3/20/00 aaa Time: 9:20tud cee pee ee cegmame Mit ane dc ncleabinesine Pages: 16 Duration: 4min8sec f---" még "83.20 «9:25AM = AHCA/MEDICAL. Mowtees Ue NO.146-P.6/16 yen any 4. Between on or about January 13, 1994, and October, 1995, Respondent treated Patient MR., a thirty-five (35) year old female, for infertility. Patient M.R. never became pregnant during her treatment by the Respondent. ‘ 5. During the aforementioned period, Respondent treated Patient M.R.’s infertility by prescribing Clomid. 6. Clomid (clomiphene citrate) is a legend drug as defined by Section 465.003(7), Florida Statutes, used as an infertility drug for inducing ovulation. Clomid is administered periodically, one Clomid course being administered during one menstrual cycle, Clomid therapy follows the tule of diminishing retums, such that the likelihood of conception diminishes with each succeeding course of therapy. For this reason, if pregnancy has not been achieved after six (6) Clomid COUTSES, further treatment with Clomid i is not recommended. Good medical practice requires that all candidates for Clomid therapy ‘be carefully evaluated prior to initiation of Clomid treatment and also after each Clomid course to ascertain the patient’s response to treatment. 7. Between on or about January 13, 1994, and a October, 1995, Respondent administered mote that six (6) Clomid courses sto atient MR. 8. A reasonably prudent similar Physician Practicing under similar conditions and cireumstances as Respondent (hereinafter “ a reasonably prudent physician’ ¥) would cease treating Patient MR.’ $ infertility after the six Clomid treatments. Prolactin and thyroid stimulating hormone. . 7 a _Prior to prescribing Clomid to Patient M. R. Respondent did not 3 oder a 1 blood test for Received Event (Event Succeeded) Date: 3/20/00 Pages: 16 Duration: 4 min 8 sec fo" AR /26./2@a = 9:25AM = AHCA/MEDICAL , Towiews 8 NO.146 0 P.7716 _ _ 10. A reasonably prudent similar physician practicing under similar conditions and cizcumstances as Respondent would have ordered a blood test for Prolactin and thyroid stimulating hormone prior to prescribing Clomid to Patient M.R. 11. After each Clomid course, Respondent did not evaluate Patient M.R.’s response to treatment with Clomid by a mucus check, urine LH testing, pelvic ultrasounds or a luteal phase progesterone. 12. A reasonably prudent physician would have properly evaluated Patient M.R.’s response to treatment with Clomid by a mucus check, urine LH testing, pelvic ultrasounds or a luteal phase progesterone. 13, Respondent did not precede each Clomid treatment cycle of Patient M.R. by a pelvic examination or by a pelvic ultrasound to rule out an ovarian cyst. 14. In order to mule out an ovarian cyst, a reasonably prudent physician would have preceded each Clomid treatment cycle of Patient M.R. by a pelvic examination or by a pelvic ultrasound. oviduets following: a special Baie 16. The HSG report : for Patient M. Ri is included i in n Respondents medical Teconds, The ; sedishagiit ‘who wrote the HSG Teport indicated that Patient M.R.’s uterine cavity appeared distorted due to an intramural fibroid in the left comua. The radiologist also recommended in his report that if the intramural fibroid is not known to exist, ultrasound might be useful for confirmation. 17. Respondent did not discuss the results of the HSG with Patient MR, Time: 9:20 wed ' Be Bel et hia Received Event (Event Succeedec’ . 3/20/00 ‘Date: Pages: nee 16 Duration: 4 min 8 sec wnat. a mag S3. 20a 9:268M AHCA/MEDICAL NO.146 P8716 : _ . 18. Respondent did not notify Patient MLR. about the abnormality of her uterine cavity. 19, Respondent did not follow up the radiologist's s advice with further testing such as ultrasound to confirm the intramural fi broid, 20. During her treatment with Respondent, Patient M.R. complained to Respondent of heavy menses. Respondent explained to Patient M.R. that the heavy menses were due to her taking Clomid. 21. Ovulation induction with Clomid is not commonly associated with heavy menses. 22, Respondent failed to consider the association between Patient M.R.’s heavy menses and a possible intrauterine lesion as suggested by HSG. 23, Respondent did not consider the association between Patient MLR.’s infertility and a possible intrauterine lesion as suggested by HSG. 24. A reasonably prudent physician would be have suspended Patient M.R.’s treatment with Clomid until resolving the intrantural fibroid i issue. 25. in or eround October 1995, after requesting a 2 COPY of Respondent’ s medical records, Patient M. R. took ‘the initiative and stopped her treatment with Respondent and transferred to a subsequent treating physician. _ 26. The subsequent treating physician reviewed Respondent $ records for Patient MLR. and notified the patient o of the sbnormality in her utems. 27, Subsequently, Patient M. R had surgery with excision of on intrauterine lesion. 28. On or about July 23, 1997, Patient M.R. was tested positive for pregnancy. ~ Time: 9:20 ‘ eel Be 8 Received Event (Event Succeeded) ; Date: Pages: Geock - 3/20/00 Time: 9:20 i) 16 Duration: 4 min 8 sec mas"26. 30a 9:26AM — AHCA/MEDICAL _ NO.146 P.9/16 _ a COUNT ONE 29, Petitioner realleges and incorporates paragraphs one (1) through twenty-eight (28), as if fully set forth herein this Count One, , 30. Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being pert - smelog girgil = conditions and circumstances with regard to Patient M.R. Specificaliy, ‘Respondent failed to order a blood test for Prolactin and thyroid stimulating hormone prior to prescribing Clomid to Patient M.R.; failed to properly evaluate Patient M.R.’s response to treatment with Clomid by a mucys check, urine LH testing, pelvic ultrasounds ora luteal phase progesterone; failed to precede each treatment cycle of Patient M.R. with Clomid by a pelvic examination or by a pelvic ultrasound; failed to discuss with Patient M.R. the results of the HSG; failed to notify Patient MR. ‘about the abnormality of her uterine cavity; failed to follow up the radiologist’s advice with further testing such as ultrasound to confirm the intramural fibroid; failed to consider the association between Patient M.R.’s heavy menses and a possible intrauterine Jesion as suggested by HSG; failed to consider the association between Patient M.R.’s infertility and a possible intrauterine lesion as suggested by HSG: and, failed to suspend Patient M.R.’s treatment with Clomid until resolving the i issue of the intramural fibroid. 31., Based on the foregoing, Respondent violated Section 458, 833100 Florida Statutes, __ by gross or repeated malpractice or the failure to Practice 1 medicine with that level of care, skill, “and treatmen ognized by asonably pri under similar conditions and circumstances. es bing acceptable ee eR a jit, Be - Date: Received Event (Event Succeeded" j 3/20/00 ~ Time: 9:20 eid 16 AADD nn MAR’26.20@0 9:260M RHCA-MEDICAL NO. 146 P.10716 Duration: 4 min 8 sec wast. a — Nee co TWO . 32. Petitioner realleges and incorporates paragraphs one (1) through twenty-eight (28) and paragraph thirty (30) as if fully set forth herein this Count Two, 33, Respondent failed to keep appropriate medical récords for Patient M.R. in that Respondent failed to justify in his medical records his medical reasons for his failure to order a blood test for Prolactin and thyroid stimulating hormone prior to prescribing Clomid to Patient M.R.; failed to justify in his medical records his medical reasons for his failure to properly evaluate Patient MR’s response to treatment with Clomid by a mucus check, urine LH testing, pelvic ultrasounds or a luteal phase Progesterone; failed to Justify in his medical records his medical reasons for his failure to precede each treatment cycle of Patient M.R, with Clomid by a pelvic examination or by a pelvic ultrasound; failed to justify in his medical records his medical reasons for his failure to discuss with Patient MLR. the results of the HSG; failed to justify the medical reasons for his failure to notify Patient M.R. about the abnormality of her uterine cavity; failed to justify in his medical records his medical reasons for his failure to follow up the radiologist’s advice with further testing such as ultrasound to confirm the intramural fibroid; failed to justify in his medical records his medical reasons for his failure to consider the association between Patient M.LR.’s heavy menses and a possible intrauterine lesion as suggested by HSG; failed to Justify i in his medical records his medical reasons for his faire to consider "the association between Patient MR. 's infertility an and a possible inhauterine lesion as suggested by ‘SG; and, failed to justify i in his medical Tecords his medical reasons ‘for his failure to suspend tient MR’ 's treatment with Clomid until resolving thei issue of the interna fibro. 34, Based on the foregoing, Respondent violated Section 458.331(1)(m), Florida Statutes, by failing to keep medical records justifying the course of treatment of the patient, 6 “10 Received Event (Event Succeede Date: 3/20/00 Time: 9:20 bau Pages: 16 : : Duration: 4 min 8 sec c--* MAR ’28.20@0 9:26AM = HCA MEDICAL mottos ae NO.146 P1116 _ — . 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 35. Petitioner realleges and incorporates paragraphs one (1) through twenty-eight (28), paragraph thirty (30), and paragraph thirty-three (33) as if fully set forth herein this Count Three, 36, During his treatment of Patient M-R., Respondent prescribed Clomid, a legend drug, inappropriately in that Respondent failed to order a blood test for Prolactin and thyroid stimulating hormone prior to prescribing Clomid to Patient M-R.; failed to’ properly evaluate Patient M.R.’s response to treatment with Clomid by a mucus check, urine LH testing, pelvic ultrasounds ot 4 luteal phase progesterone; failed to precede each treatment cycle of Patient MR. with Clomid by a pelvic examination or by a pelvie ultrasound; and, failed to suspend Patient M.R.’s treatment with Clomid until resolving the issue of the intramural fibroid. 37. Based on the foregoing, Respondent violated Section 458.331(1)(@), Florida Statutes, by prescribing, administering, mixing, ¢ or t otherwise preparing a legend drug, including any controlled substance, other ‘than i in the course eof the physician's professional practice. For the Purposes of this: ‘Paragraph, it shall be legally presumed thet prescribing, dispensing, . administering, n mixing, or ofherwise preparing legend dnigt, including all controlled substances, inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and ig not in the course of the physician's professional practice, without regard to his or her intent, aa Received Event (Event Succeeded* Date: 3/20/00 Time: 9:20 eel Pages: 16 Duration: 4 min 8 sec So--* MAR !23.20@@ 99:27AM = AHCA/MEDICAL NO.146 P1216 nant. a F ko . ay ww . 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 Respondents practice, imposition of an administrative fine, semaines of ‘i 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 attommey’s time, as provided for in Section 455.624(3), Florida Statutes, and/or any other relief that the Board deems appropriate. SIGNED this pd day of __ WU 1999, Robert G. Brooks, M.D., Secretary : ary G. McPherson, Jr. * _ Chief Medical Attomey COUNSEL FOR DEPARTMENT: Lany G. McPherson, ke. Chief Medical Attomey | Agency for Health Care Administration ean P.O.Box 14229 — BRRARTMERY Slane Tallahassee, Florida 32317-4229 OQ, ners Florida Bar #788643 . CLERK scram ware, A309 ——— PCP: February 26, 1999 PCP Members: Slade, Murray’ 12 eee genera nape oe

Docket for Case No: 00-001196