ton es A - OP STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, Ve CASE NO. 2012-03027 RONALD EVAN WHEELER, M.D., . RESPONDENT. ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health, by and through undersigned counsel, and files this Administrative Complaint before the Board of Medicine against Respondent, Ronald Evan Wheeler, M.D., and in support thereof alleges: 1. Petitioner is the state department charged with regulating the practice of medicine pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 458, Florida Statutes. 2. At all times material. to this Complaint, Respondent was a licensed physician within the State of Florida, having been issued license number ME 46625. DOH v. WHEELER, M.D., Case Number 2012-03027 Page 1 of 16 3. Respondent's address of record is: 1250 S. Tamiami Trail, Suite 101 N., Sarasota, Florida 34239. 4, Respondent has not reported any board certifications to the Department. 5. On or about December 3, 2008, Patient G.P., then a 60 year- old male living in Michigan, self-referred to Respondent via the Internet for treatment of G.P’s elevated PSA (prostate specific antigen) level. . 6. On or about December 4, 2008, Respondent spoke to Patient G.P. by telephone and recommended an appointment and MRI study. 7. PSA level is determined from a blood screening test and is present in small quantities in the serum of men with healthy prostates but is often elevated in the presence of prostate cancer or other prostate disorders such as_ prostatitis, irritation, and benign prostatic hyperplasia (BPH). | 8. The reference range for a normal PSA level is from 0.1 to 4.0 nanograms per milliliter. (ng/mL). PSA levels between 4 and 10 ng/mL are abnormal. DOH v. WHEELER, M.D., Case Number 2012-03027 : Page 2 of 16 9. On or about December 6, 2008, Patient PG. presented in person for the first time to Respondent at Respondent's clinic, Diagnostic Center for Disease, in Sarasota, Florida (‘DCD”). . 10. On the Patient Referral and Clinical Data Form (undated), Respondent noted that Patient G.P. had a family history of prostate cancer — and additional history which included: (a) a PSA of 3.7 in December of 2005 with biopsies negative for prostate cancer but revealing benign prostatic hyperplasia (BPH); (b) a PSA of 6.4 on November 18, 2008. 11. On the Patient Referral and Clinical Data Form, Respondent noted his impression of: “BPH, Prostatitis, L sided Prostate Atypia.” The plan of treatment was “CDM.” The term “CDM” stands for Chronic Disease Protocol, as described below. 12. A reasonably-prudent physician practicing within the prevailing professional standard of care, whose patient’s PSA increased from 3.7 to 6.4 from 2005 to 2008, and whose only biopsies in 2005 were negative, would have performed a complete physical examination and review of DOH v. WHEELER, M.D., Case Number 2012-03027 Page 3 of 16 systems of the patient on the first visit, before recommending tests or treatments such as an MRI or new medications. 13. On or about December 6, 2008, Respondent failed to perform a complete physical examination or any review of systems of Patient G.P. before prescribing the new medication Casodex, or failed to document such actions. 14, On or about January 5, 2009, Patient G.P’s second visit to Respondent's clinic, an MRI study was performed by Dr. G.G. The MRI report stated that the findings are: suspicious for prostate cancer. I would recommend correlation with MR spectroscopy. If targeted biopsies are being considered, these are certainly of keen interest. [The impression is] 1. benign prostatic hypertrophy changes as described above. 2... . suspicious for the presence of prostate cancer. However, I would recommend correlation with chemical signature by MR spectroscopy. 15. On the “Urology Interpretation” (undated) based on the MRI findings, Respondent's impression was “findings suspicious for prostate cancer” 16. Respondent further noted that the MRI findings could indicate solely chronic inflammation of the prostate gland (Prostatitis) or an increase in the size of the prostate (benign prostatic hypertrophy or BPH), DOH v. WHEELER, M.D., Case Number 2012-03027 Page 4 of 16 but could also be consistent with the concurrent presence of prostate cancer. 17. Respondent noted in the Urology Interpretation that the risk assessment for prostate cancer was “moderate.” . 18. Respondent noted in the Urology Interpretation certain treatment options: “High Intensity Focused Ultrasound (HIFU) represents the most precision definitive treatment option available in the event prostate cancer is diagnosed with targeted biopsies (www.PanAMHiFU.com).” 19. In the Urology Interpretation under Best Recommendation, Respondent noted: Notwithstanding the current PSA, I am recommending an opportunity to improve the disease characteristics with a Chronic Disease Management protocol deferring biopsy for the immediate future ... .In the interim, conservative measures should be employed through the various mechanisms of action that have been shown to impact prostate cancer, consistent with the CDM Protocol. 20. On or about February 9, 2009, Respondent called in prescriptions for two prostate medications, Avodart 0.5 mg and Uroxatral “10 mg, for Patient G.P. DOH v. WHEELER, M.D., Case Number 2012-03027 Page 5 of 16 21. Avodart (trademark name for Dutasteride) is used to treat benign prostatic hyperplasia (BPH). Uroxatral (the brand name for Aifuzosin) is also used to treat BPH. 22. On or about April 21, 2009, Patient G.P’s PSA level had decreased to 4.6. 23. Generally, Patient G.P’s PSA laboratory studies were performed in his hometown in Michigan and were sent to Respondent's office in Sarasota, Florida. 24. On or about December 23, 2009, Patient G.P’s PSA level had increased to 5.2. 25. On or about January 15, 2010, Respondent prescribed Casodex at 150 mg daily for one month. 26. Casodex (a brand name for Bicalutamide) is a non-steroidal anti-androgen used in the treatment of advanced prostate cancer and earlier stages of the disease. . 27. A reasonably-prudent physician practicing within the prevailing professional standard of care, whose patient’s PSA increased from 3.7 to 6.4 from 2005 to 2008, whose only biopsies in 2005 were negative, whose MRI findings in January of 2009 were inconclusive for prostate cancer, DOH v. WHEELER, M.D., Case Number 2012-03027" : Page 6 of 16 - would have performed a complete physical examination and review of systems of the patient before recommending new treatments for prostate cancer, such as new medication. 28. On or about January 15, 2010, Respondent failed to perform any physical examination or review of systems before prescribing the new medication Casodex, or failed to document such actions. 29, On or about February 11, 2010, Patient G.P’s PSA level had decreased to 3.65. 30. On or about March 5, 2010, Patient G.P’s PSA level had decreased to 2.6. | 31. At some point in time prior to March 8, 2010, Respondent recommended that Patient G.P. undergo HIFU treatment (high intensity focused ultrasound). 32. No HIFU device has been approved by the U.S. Federal Drug Administration for the treatment of prostate cancer. 33. A reasonably-prudent physician practicing within the prevailing professional standard of care, whose patient’s PSA increased from 3.7 to 6.4 from 2005 to 2008, whose only biopsies in 2005 were negative, whose MRI findings in January of 2009 were inconclusive for prostate cancer, and DOH v. WHEELER, M.D., Case Number 2012-03027 Page 7 of 16 whose PSA had decreased to 2.6 by March of 2010, would have obtained a biopsy of the patient’s prostate before diagnosing and treating the patient for prostate cancer. 34. On or about March 8, 2010, Respondent failed to order adequate diagnostic testing, including a biopsy of Patient G.P’s prostate tissue, before diagnosing Patient G.P. with prostate cancer. | 35. On or about March 8, 2010, Respondent failed to adequately diagnose Patient G.P. before recommending treatment for prostate cancer. 36. On an undated form labeled “Patient Information for HIFU,” Respondent noted that Patient G.P’s PSA level was 2.6 as of March 8, 2010; Digital Rectal Exam was noted as “Tic: evidence of BPH;” Evidence of Prostatitis was noted as “yes, based on PSA;” Cancer was noted as “yes — confirmed with a 3 T MRI-S scan on Left side;” Gleason Score was noted as “N/A;” and Cancer Stage was noted as “T2c; MRI-Spectroscopy confirms the presence of Prostate Ca.” 37. Respondent documented on the form entitled Patient Information for HIFU that Patient G.P. had prostate cancer despite previous inconclusive test results. DOH v. WHEELER, M.D., Case Number 2012-03027 Page 8 of 16 38. Respondent documented on the form entitled Patient Information for HIFU that ‘Patient G.P. had prostate cancer without performing a biopsy to rule out prostate cancer. 39. On or about March 8, 2010, a pre-operative clearance evaluation for a scheduled HIFU procedure was prepared by Dr. J.M., D.O., at Metropolitan Hospital. The system review portion of the form indicated “abnormal” conditions as “Prost. CA ... BPH”. 40. On or about April 9-11, 2010, Patient G.P. underwent HIFU treatment for prostate cancer in Cancun, Mexico. 41. On or about April 25, 2011, Patient G.P. presented to Dr. G.C. with complaints of urinary retention due to posterior urethral scarring resulting from the HIFU treatment, and underwent cystoscopy with electro- vaporization of scarring. . 42. On or about September 23, 2011, Patient G.P. presented to Dr. J.G. with severe obstruction of his urethra. After cystoscopy and retrograde urethrogram, Dr. J.G. informed Patient G.P, that he had a very significant problem and discussed all options. Dr J.G. recommended endoscopic treatment with balloon ‘dilation and then transurethral resection of the DOH v. WHEELER, M.D., Case Number 2012-03027 Page 9 of 16 prostate, with risk to the external sphincter and risk of incontinence, and given the nature of the tissue damage, a tisk of recurrent obstruction. COUNT I 43. Petitioner re-alleges and incorporates Paragraphs One (1) through Thirty-Eight (38), as if fully set forth herein. 44, Section 458.331(1)(t)1, Florida Statutes (2008, 2009), subjects a physician to discipline for committing medical malpractice as defined in Section 456.50. “Medical malpractice” is defined by Section 456.50(1)(9), Florida Statutes (2008, .2009), as “the failure to practice medicine in accordance with the level of care, skill, and treatment recognized in general law related to health care licensure.” . 45. Section 456.50(1)(e), Florida Statutes (2008, 2009), provides that the “level of care, skill, and treatment recognized in general law related to health care licensure" means the standard of care that is specified in Section 766.102, Florida Statutes, as follows: The prevailing professional standard of care for a given health care provider shall be that level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers. DOH v. WHEELER, M.D., Case Number 2012-03027 Page 10 of 16 46. Respondent failed to meet the prevailing standard of care in one or more of the following ways: a) b) c) qd) e) By failing to adequately assess Patient G.P., by failing to , perform a complete physical examination or review of systems, on or about December 6, 2008; and/or By failing to adequately assess Patient G.P., by failing to perform a complete physical examination or review of systems, on or about January 5, 2009; and/or By failing to adequately assess Patient G.P,, by failing to perform any physical examination or review of systems on or about January 15, 2010; and/or By failing to order adequate diagnostic testing before diagnosing patient G.P. with prostate cancer on or about March 8, 2010; and/or By failing to adequately diagnose Patient G.P. before recommending treatment for prostate cancer on. or about March 8, 2010. 47. Based on the foregoing, Respondent violated Section 458.331(1)(t), Florida Statutes (2008, 2009), 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. DOH v. WHEELER, M.D., Case Number 2012-03027 Page 11 of 16 COUNT II 48. Petitioner re-alleges and incorporates Paragraphs One (1) through Thirty-Eight (38), as if fully set forth herein. | 49. Section 458.331(1)(m), Florida Statutes (2008, 2009), subjects a physician to discipline for 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. Respondent failed to maintain adequate medical records that justified the course of treatment for Patient G.P. in one or more of the following ways: a) By failing to adequately document a complete physical examination or review of systems, on or about December 6, 2008; and/or DOH v, WHEELER, M.D., Case Number 2012-03027 Page 12 of 16 b) By failing to adequately document a complete physical examination or review of systems, on or about January 5, 2009. 51. Based on the foregoing, Respondent violated Section 458.331(4)(m), Florida Statutes (2008, 2009), by failing to keep legible medical records that justify the course of treatment of the patient. COUNT III 52. Petitioner re-alleges and incorporates Paragraphs One (1) through Thirty-Eight (38), as if fully set forth herein. 53. Section 458.331(1)(k), Florida Statutes (2008, 2009), subjects a physician to discipline for making deceptive, untrue, or fraudulent representations in or related to the practice of medicine or employing a trick or scheme in the practice of medicine. 54. Respondent made deceptive, untrue, or fraudulent representations in or related to the practice of medicine or employed a trick or scheme in the practice of medicine with regard to Patient G.P. in one or more of the following ways: a) By documenting on or about March 8, 2010 that Patient G.P. had prostate cancer despite previous test results which were inconclusive; and/or DOH vy. WHEELER, M.D., Case Number 2012-03027 Page 13 of 16 b) By documenting on or about March 8, 2010 that Patient G.P. had prostate cancer without performing a biopsy to rule out prostate cancer. 55. Based on the foregoing, Respondent violated Section 458.331(1)(k), Florida Statutes (2008, 2009), by making deceptive, untrue, or fraudulent representations in or related to the practice of medicine or employing a trick or scheme in the practice of medicine. WHEREFORE, Petitioner respectfully requests that the Board of Medicine enter an order imposing one or more of the following penalties: permanent revocation or suspension of Respondent's license, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of Respondent on probation, corrective action, refund of fees billed or collected, remedial education and/or any other relief that the Board deems appropriate. DOH v. WHEELER, M.D., Case Number 2012-03027 Page 14 of 16 SIGNED this 8th day of March, 2013. John H. Armstrong, MD, FACS, FCCP State Surgeon General & Secretary of Health, Sta of Florida Assistant General Counsel Fla. Bar No. 0861413 Florida Department of Health DEPARTMENT OF HEALTH Office of the General Counsel CLERK Deputy CLERK _ 4052 Bald Cypress Way, Bin C-65 DATE MAR 3 oat Tallahassee, Florida 32399-3265 Telephone: (850) 245-4640 Facsimile: (850) 245-4681 Email: Laura_Glenn@doh.state.fl.us LLG PCP: 2/15/13 PCP Members: Dr. S. Rosenberg, Dr. El Sanadi -' ss f+: DOH v. WHEELER, M.D., Case Number 2012-03027 Page 15 of 16 DOH v. WHEELER, M.D., Case Number 2012-03027 NOTICE OF RIGHTS Respondent has the right to request a hearing to be conducted in accordance with Section 120.569 and 120.57, Florida Statutes, to be represented by counsel or other qualified representative, to present evidence and argument, to call and cross-examine witnesses and to have subpoena and subpoena duces tecum issued on his or her behalf if a hearing is requested. NOTICE REGARDING ASSESSMENT OF COSTS Respondent is placed on notice that Petitioner has incurred costs related to the investigation and prosecution: of this matter. Pursuant to Section 456.072(4), Florida Statutes, the Board shall assess costs related to the investigation and prosecution of a disciplinary matter, which may include attorney hours and costs, on the Respondent in addition to any other discipline imposed. DOH v. WHEELER, M.D., Case Number 2012-03027 Page 16 of 16

Docket for Case No: 14-000113PL