STATE OF FLORIDA DEPARTMENT OF HEALTH FLORIDA DEPARTMENT OF HEALTH, Petitioner, V. Case Number: 2012-06492 FERNANDO VALLE, M.D., Respondent. ADMINISTRATIVE COMPLAINT Petitioner Department of Health files this Administrative Complaint before the Board of Medicine against Respondent Fernando Valle, M.D., and states: 1a Petitioner is the state agency charged with regulating the practice of medicine, pursuant to Chapters 20, 456 and 458, Florida Statutes (2010-2011). 2. At all times material to this Complaint, Respondent was licensed to practice as a physician in the State of Florida, pursuant to Chapter 458, Florida Statutes (2010-2011), having been issued license number ME41752. Respondent's address of record is 10459 Belfry Circle, Orlando, Florida 32832. 3. At all times material to this Complaint, Respondent treated Filed September 26, 2012 3:44 PM Division of Administrative Hearings Florida Department of Health v. Fernando Valle, M.D. Case Number: 2012-06492 patients at A New Life Pain Management Clinic (the “Clinic”), a pain management clinic located at 40 Barkley Cir # 3, Fort Myers, FL 33907. FACTS SPECIFIC TO J.P. 4. Onor about December 21, 2011, Law Enforcement officer J.P. (JP”), acting in an undercover capacity, first presented to the Clinic as a twenty-eight-year-old female patient with complaints of neck/upper back and shoulder pain. JP provided copies of her medica! record from a prior- treating physician to the Clinic. JP’s prior medical record included the results of a magnetic resonance imaging (“MRI”) study of JP’s lumbar spine (lower back) dated November 28, 2011, and JP’s prescription history.’ JP’s medical record revealed a mild disc protrusion and a history of no prior surgery or treatments to her lower back. JP did not complain of pain to her lower back during her visit to the Clinic, but instead complained of pain to her neck, upper back and shoulder. JP’s medical record included a history of receiving Oxycodone 30 mg, Xanax 2 mg and Ibuprofen 600 mg from December 2, 2010, through November 11, 2011. 5. Oxycodone is commonly prescribed to treat pain. According to Section 893.03(2), Florida Statutes (2010-2011), oxycodone is a Schedule ' Jp’s medical record and prescription history were fabricated by Law Enforcement with the assistance of a cooperating physician. JP’s MRI was authentic. Florida Department of Health v. Fernando Valle, M.D. Case Number: 2012-06492 II controlled substance that has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States. Abuse of oxycodone may lead to severe psychological or physical dependence. 6. Xanax is the brand name for alprazolam and is prescribed to treat anxiety. According to Section 893.03(4), Florida Statutes (2010- 2011), alprazolam is a Schedule IV controlled substance that has a low potential for abuse relative to the substances in Schedule III and has a currently accepted medical use in treatment in the United States. Abuse of alprazolam may lead to limited physical or psychological dependence relative to the substances in Schedule III. 7. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) used to reduce fever and treat pain or inflammation. 8. During the course of this initial visit, JP reported a pain level of five on a scale of one-through-ten without pain medication and two on a scale of one-through-ten with pain medication. JP was asked by a medical assistant at the Clinic to undergo a urine drug screen, which was negative for any substances, including those controlled substances that were previously prescribed to JP. Florida Department of Health vy. Fernando Valle, M.D, Case Number: 2012-06492 9. After paying her visit fee of $125.00, JP was escorted into an examination room, where she was met by Dr. Valle. Dr. Valle then proceeded to perform a physical examination of JP. During the examination, which lasted less than three minutes, JP remained seated. 10. Following the examination, Dr. Valle advised JP that “there's not much wrong with your back.” Dr. Valle informed JP that he would not prescribe a CAT (Computed Axial Tomography) scan or MRI for JP because he did not want to expose her to radiation. Dr. Valle further informed JP that she appeared to have a heart murmur and should see a cardiologist. Dr. Valle did not, however, provide JP with a referral to a cardiologist. 11. At the conclusion of this visit, Dr. Valle provided JP with prescriptions for.60 dosage units of Roxicodone 30 mg, 60 dosage units of MS Contin 30 mg, 30 dosage units of Xanax 2 mg, 60 dosage units of Naprosyn 250 mg and 30 dosage units of Flexeril 10 mg. 12. Roxicodone is a brand name for oxycodone. 13. MS Contin is the brand name for a drug that contains morphine and is prescribed to treat pain. According to Section 893.03(2), Florida Statutes (2010-2011), morphine is a Schedule II controlled substance that has a high potential for abuse and has a currently accepted but severely Florida Department of Héalth v. Fernando Valle, M.D. Case Number: 2012-06492 restricted medical use in treatment in the United States. Abuse of morphine may lead to severe psychological or physical dependence. 14. Naprosyn is a nonsteroidal anti-inflammatory drug (NSAID) and is used to treat pain or inflammation. 15. On or about January 17, 2012, JP went to the Clinic for a follow-up visit with Dr. Valle. After paying a visit fee of $225.00, JP was escorted to an examination room where a medical assistant took JP’s weight and inquired about JP’s pain level. In response, JP reported a pain level of five on a scale of one-through-ten without pain medication and three on a scale of one-through-ten with pain medication. JP then advised the medical assistant that four days prior to this visit, she had ingested the last of the Oxycontin 30 mg Dr. Valle had prescribed to her during prior visit. 16. Upon entering the examination room, Dr. Valle noted that JP was not scheduled for an appointment until January 18, 2012. When JP explained that she was early because she could not make the January 18" appointment, Dr. Valle then questioned JP about why she had finished a thirty-day supply of Oxycontin 30 mg in just twenty days. JP told Dr. Valle that she had stopped taking the MS Contin he had prescribed to her Florida Department of Health v. Fernando Valle, M.D. Case Number: 2012-06492 because it was not working for her and that she had resorted to taking more of the Oxycontin 30 mg as a consequence. 17. Dr. Valle then proceeded to perform a physical examination of JP’s upper back and shoulder area, which lasted a total of approximately five seconds. JP remained seated during the entire examination. Dr. Valle then advised JP that he would not require her to undergo an MRI of her upper back because it was unnecessary. 18. At the conclusion of this visit, Dr. Valle prescribed 90 dosage units of Roxicodone 30 mg, 30 dosage units of Xanax 2 mg, 60 dosage units of Naprosyn 250 mg, 30 dosage units of Flexeril 10 mg and 60 dosage units of Tramadol 200 mg to JP. JP’s visit with Dr. Valle lasted a total of eight minutes. 19. Flexeril is a muscle relaxant used to treat skeletal muscle conditions such as pain or injury. 20. Tramadol is an opioid-class medication prescribed to treat pain. Tramadol is a legend drug, but not a controlled substance. Tramadol can affect mental alertness, is subject to abuse and can be habit forming. 21. An independent medical expert, who is Board-Certified in Pain Management, Anesthesiology and Interventional Pain Management, Florida Department of Health v. Fernando Valle, M.D. Case Number: 2012-06492 reviewed the treatment provided by Dr. Valle to JP and opined Dr. Valle fell below the standard of care in several respects. In particular, the expert found Dr. Valle failed to utilize a multi-disciplinary approach in his treatment of JP; prescribed controlled substances to the patient without medical justification; failed to perform radiologic or physical examinations of the patient’s neck or shoulder areas (the patient's main complaint); failed to provide a written treatment plan to the patient; failed to order diagnostic or objective tests; and prescribed controlled substances to JP after the patient reported running out of medication early, reported no increases in pain and tested negative for the substances during drug screens. Facts Specific to P.S. 22. On or about January 11, 2012, Law Enforcement officer P.S. (“PS”), acting in an undercover capacity, first presented to the Clinic as a thirty-eight-year-old male patient with complaints of lower back pain. After paying an initial visit fee of $125.00, PS was escorted into an examination room by a medical assistant. PS provided copies of his medical record from a prior-treating physician to the Clinic. PS’s prior medical record included the results of a MRI study of PS’s neck/upper back dated Florida Department of Health v. Fernando Valle, M.D. Case Number: 2012-06492 December 19, 2011, which revealed a small disc herniation in PS’s upper back, but no other abnormalities.” 23. During the course of this initial visit, PS reported a pain level of five on a scale of one-through-ten without pain medication and two on a scale of one-through-ten with pain medication. PS was asked by a medical assistant at the Clinic to undergo a urine drug screen. 24. After entering the examination room, Dr. Valle advised PS that he would need to obtain an MRI of his lower back in order to be seen for his back pain. Dr. Valle then provided PS with a prescription for an MRI and told PS to return to the Clinic after undergoing the MRI. Dr. Valle did not perform an examination of PS at any time during this visit. 25. On January 30, 2012, PS returned to the Clinic for a follow-up visit. PS brought the results of an X-ray of his lower back to this visit. Contrary to the prescription provided by Dr. Valle, PS did not undergo an MRI. After being escorted into an examination room, PS again reported a pain level of five on a scale of one-through-ten without pain medication and two on a scale of one-through-ten with pain medication. 26. Upon entering the examination room where PS was waiting, Dr. 2 PS’s medical record and prescription history were fabricated by Law Enforcement with the assistance of a cooperating physician. PS’s MRI was authentic. Florida Department of Health v. Fernando Valle, M.D. Case Number: 2012-06492 Valle described the results of PS’s X-ray as “not that bad” and asked PS how many dosage units of oxycodone 30 mg he had taken in the past seven days. PS advised Dr. Valle he had taken an average of four oxycodone 30 mg per day despite the fact that PS did not have a current prescription for oxycodone 30 mg. Dr. Valle proceeded to conduct an examination of PS that lasted approximately sixty-five seconds. During the ‘examination, PS remained seated and did not complain of pain. At the conclusion of this visit, Dr. Valle prescribed 120 dosage units of Roxicodone 30 mg, 60 dosage units of MS Contin 15 mg and 30 dosage units of Mobic 15 mg. Dr. Valle failed to discuss any other treatment options with PS. 27. Mobic is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation caused by arthritis. 28. On or about February 27, 2012, PS returned to the Clinic for a follow-up visit with Dr. Valle. After being escorted into an examination room by a medical assistant, PS again reported a pain level of five on a scale of one-through-ten without pain medication and two on a scale of one-through-ten with pain medication. PS also reported that he had run out of Roxicodone 30 mg about five days prior to his visit to the Clinic. After Dr. Valle entered the examination room, PS advised him that the MS Florida Department of Health v. Fernando Valle, M.D. Case Number: 2012-06492 Contin Dr. Valle had prescribed to him during his prior visit had made him nauseous. In response, Dr. Valle told PS he would discontinue his prior prescription for MS Contin and increase his dosage units of oxycodone 30 mg. 29, At the end of this visit, which lasted approximately six minutes, Dr. Valle prescribed 150 dosage units of oxycodone 30 mg (an increase of 30 dosage units from the previous visit) to PS. Dr. Valle did not conduct a physical examination of PS during this visit. 30. An independent medical expert, who is Board-Certified in Pain Management, Anesthesiology and Interventional Pain Management, reviewed the treatment provided by Dr. Valle to PS and opined Dr. Valle fell below the standard of care in several ways. In particular, the expert found Dr. Valle performed inadequate or no physical examinations of the patient, failed to utilize a multi-disciplinary approach in his treatment of the patient; prescribed controlled substances to the patient without medical justification; failed to provide a written treatment plan to the patient, and prescribed controlled substances to the patient after the patient reported running out of medication early, reported no increases in pain and tested negative for the substances during drug screens. 10 Florida Department of Health v. Fernando Vaile, M.D. Case Number: 2012-06492 COUNT I — SECTION 458.331(1)(t), FLORIDA STATUTES 37. Petitioner realleges and incorporates paragraphs 1 through 30 above, as if set forth herein. 38. Section 458.331(1)(t)1, Florida Statutes (2010-2011), subjects a physician to discipline, including suspension, for committing medical malpractice as defined in Section 456.50, Florida Statutes (2010-2011). “Medical malpractice” is defined by Section 456.50(1)(g), Florida Statutes (2010-2011), 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.” Section 456.50(1)(e), Florida Statutes (2010-2011), provides that the “level of care, skill, and treatment recognized in general jaw related to health care licensure" means the standard of care that is specified in Section 766.102(1), Florida Statutes (2010-2011), which states 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. 11 .. Florida Department of Health v. Fernando Valle, M.D. Case Number: 2012-06492 39. Section 458.331(1)(t)1., Florida Statutes (2010-2011), directs the Board of Medicine to give “great weight” to this provision of Section 766.102, Florida Statutes (2010-2011). . 40. Respondent failed to meet the prevailing standard of care and, therefore, violated Section 458.331(1)(t)1., Florida Statutes (2010-2011), in one or more of the following manners: a. By prescribing inappropriate quantities of controlled substances to Patients JP and PS without justification; b. By failing to employ other modalities for the treatment of pain in connection with Patients JP and PS; and c. By failing to order appropriate diagnostic or objective tests for Patients JP and PS. COUNT II — SECTION 458.331(1)(q), FLORIDA STATUTES 31. Petitioner realleges and incorporates paragraphs 1 through 30 above, as if set forth herein. 32. Section 458.331(1)(q), Florida Statutes (2010-2011), subjects a licensee to discipline for 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. It is legally 12 Florida Department of Health v. Fernando Valle, M.D. Case Number: 2012-06492 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. | 33. Respondent violated Section 458.331(1)(q), Florida Statutes (2010-2011), by prescribing controlled substances inappropriately or in excessive or inappropriate quantities to Patients JP and PS. COUNT III — SECTION 458.331(1)(nn), FLORIDA STATUTES 34. Petitioner realleges and incorporates paragraphs 1 through 30 above, as if set forth herein. 35. Section 458.331(1)(nn), Florida Statutes (2010-2011), subjects a physician to discipline for violating any provision of Chapters 456 or 458, Florida Statutes, or any rules adopted pursuant thereto. 36. Rule 6488-9.013, Florida Administrative Code, sets forth standards for the use of controlled substances for the treatment of pain, in part, as follows: (3) Standards. The Board has adopted the following standards for the use of controlled substances for pain control: (a) Evaluation of the Patient. A complete medical history 13 Florida Department of Health v. Fernando Valle, M.D. Case Number: 2012-06492 and physical examination must be conducted and documented in the medical record. The medical record shall 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 shall document the presence of one or more recognized medical indications for the use of a controlled substance. (b) Treatment Plan. The written treatment plan shall state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and shall indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician shall adjust drug therapy, if necessary, 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. (e) Consultation. The physician shall be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention must 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. (f) Medical Records. The physician is required to keep accurate and complete records to include, but not be limited to: 1. The complete medical history and a_ physical 14 Florida Department of Health v. Fernando Valle, M.D. Case Number: 2012-06492 examination, including history of drug abuse or dependence, as appropriate; 2. Diagnostic, therapeutic, and laboratory results; 3. Evaluations and consultations; 4. Treatment objectives; 37. Respondent violated Rule 64B8-9.013, Florida Administrative Code, in one or more of the following manners: a. By failing to document an adequate treatment plan for Patients JP and PS. b. By failing to conduct or document an adequate physical examination of Patients JP and PS; c. By failing to document adequate justification for the prescription of controlled substances to Patients JP and PS; and d. By failing to appropriately monitor Patients JP and PS for drug diversion or drug abuse. WHEREFORE, Petitioner respectfully requests 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 the Respondent on probation, corrective action, refund of fees billed or 15 Florida Department of Health v. Fernando Valle, M.D. Case Number: 2012-06492 collected, remedial education and/or any other relief the Board deems appropriate. SIGNED this__24* day of Sel, 2012. John H. Armstrong, MD State Surgeon General and Secretary of Health HBP Daniel evhandez Chief Legal Counsel _ FILED DOH Prosecution Services Unit DEPARTMENT OF HEALTH 4052 Bald Cypress Way, Bin C-65 CLERK Angel Sanders Tallahassee, FL 32399-3265 DATE JUL 25 2049. Florida Bar No.: 176834 (850) 245-4640 (850) 245-4681 FAX PCP Members: Or, Nuss + Ms , Goerseh PoP: 7/242 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. 16 Florida Department of Health v. Fernando Valle, M.D. Case Number: 2012-06492 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 any other discipline imposed. 17

Docket for Case No: 12-003217PL