(Y- “a7 . z Fi EN STATE OF FLORIDA “ DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, Vv. - Case Numbers 2002-26339 2002-26341 . JEROME F. WATERS, M.D., RESPONDENT. ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health, by and through its undersigned counsel, and files this Administrative Complaint before the Board of Medicine against Respondent, Jerome F. Waters, 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 7236. 3. Respondent's address of record is 237 North East 33” Street, Miami, Florida 33137-3809. 4. Respondent is not board certified. 5. Rule 64B8-9.013(3), Florida Administrative Code (FA.C.) (1999), entitled Standard for the Use of Controlled Substances for Treatment of Pain, states: Standards. The Board has adopted the following standards for the use of controlled substances for pain control: (a) (b) Evaluation of the Patient. A Complete medical history and physical examination must be conducted and documented in the medical record. The medical record should 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 should document the presence of one or more recognized medical indications for the use of a controlled substance. Treatment Plan. The written treatment plan should state objectives that will be used to determine treatment success, such. as pain relief and improved physical and psychosocial 2 (c) (d) function, and should indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician should adjust drug therapy 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. Informed Consent and Agreement for Treatment. The physician should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient, or with the patient's surrogate or guardian if the patient is incompetent. The ‘patient should receive prescriptions from one physician and one pharmacy where possible. If the patient is determined to be at high risk for medication abuse or have a history of substance abuse, the physician may employ the use of a written agreement between physician and patient outlining patient responsibilities, including, but not limited to: 1. Urine/serum medication levels screening when requested; 2. Number and frequency of all prescription refills; and 3. Reasons for which drug therapy may be discontinued (i.e., violation of agreement). Periodic Review. At reasonable intervals based on the individual circumstances of the patient, the physician should review the course of treatment and any new information about the etiology of the pain. Continuation or modification of therapy should depend on the physician's evaluation of progress toward stated treatment objectives such as improvement in patient's pain intensity and 3 (e) (f) improved physical and/or psychosocial function, i.e., ability to work, need of health care resources, activities of daily living and quality of social life. If treatment goals are not being achieved, despite medication adjustments, the physician should reevaluate the appropriateness of continued treatment. The physician should monitor patient compliance in medication usage and related treatment plans. Consultation. The physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention should 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 may require extra care, monitoring, and documentation, and may require consultation with or referral to an expert in the management of such patients. Medical Records. The physician is required to keep accurate. and complete records to include, but not to be limited to: 1. The medical history and physical examination; 2. Diagnostic, therapeutic, and laboratory results; 3. Evaluations and consultations; 4. Treatment objectives; 5. Discussion of risks and benefits; 6. Treatments; 7. Medications (including date, type, dosage, and quantity prescribed); 8. Instructions and agreements; and 9. Periodic reviews. Records must remain current and be maintained in an accessible manner and readily available for review. (g) Compliance with Controlled Substances Laws and Regulations. To prescribe, dispense, or administer controlled substances, the physician must be licensed in the state and comply with applicable federal and state regulations. Physicians are referred to the Physicians Manual: An Informational Outline of the Controlled Substances Act of 1970, published by the U.S. Drug Enforcement . Agency, for specific rules governing controlled substances as well as applicable state regulations. CASE # 2002-26339 - PATIENT F.K. 6. Onor about January 31, 2002, Patient F.K., a 46 year-old male, first presented to Respondent with complaints of back pain with pain radiating to both sides, insomnia, and depression. Patient F.K. also presented with a history of heroin addiction in the past. The patient's current medications included Methadone 80 mg./day, Oxycontin 80 mg. qid (4 times daily) and Xanax 2.0 mg. “3, 4, or 5.” There is also documented a history of Hepatitis 30 years ago, most likely: from a needie. . , 7. Methadone is a legend drug as defined by Section 465.003(7), Florida Statutes, and is a Schedule II controlled substance listed in Chapter 893, Florida Statutes. Methadone is indicated for the relief of severe pain, for detoxification treatment in cases of narcotic addiction, and for the temporary maintenance treatment of narcotic addiction. Methadone can produce drug dependence of the morphine type. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration of methadone. 8. Xanax is a legend drug as defined by Section 465.003(8), Florida Statutes, and contains alprazolam, a Schedule IV controlled substance listed in Chapter 893, Florida Statutes. Alprazolam is a benzodiazepine anxiolytic, and the abuse of alprazolam can lead to physical and psychological dependence. Xanax is indicated for the short- term relief of symptoms of anxiety. It produces additive CNS (Central Nervous System) depressant effects when co-administered with other CNS depressants. 9. Oxycontin is a legend drug as defined by Section 465.003(8), Florida Statutes, and contains oxycodone, a Schedule II controlled substance listed in Chapter 893, Florida Statutes. Oxycodone is a narcotic analgesic indicated for the relief of moderate to moderately severe pain, and carries a high potential for abuse, and abuse of the substance may lead to severe physical and psychological dependence. -40. On or about January 31, 2002, Respondent ordered jab work. Respondent also noted that X-ray reports were “on the way.” A blood pressure and pulse was recorded but no other assessment was performed. Respondent then prescribed Xanax #120 qid, Methadone 240 (8 pills/day), and Dilaudid #180 (6 per day). Respondent . also recommended Glucosamine and Chondroitin bid (twice daily). 41. Dilaudid is a legend drug as defined by Section 465.003(8), Florida Statutes, and contains hydromorphone, a Schedule II controlled substance listed in Chapter 893, Florida Statutes. Hydromorphone is a powerful narcotic analgesic indicated for the relief of moderate to severe pain, and carries a high potential for abuse and dependence, and abuse of hydromorphone may lead to severe physical and psychological dependence. 12. On or about March 4, 2002, Patient F.K. returned to Respondent's office. Respondent noted that Patient F.K. was stabilizing. Respondent noted that the X-ray report is pending at prison. Respondent does not record an adequate examination or a range of system review. The lab data was reviewed and a notation that the patient was a non- diabetic was made. Respondent then prescribed Dilaudid 4 mg. #180, Methadone #240, and Xanax 2 mg. #120. Water exercises and Glucosamine/Chondroitin were also recommended. 13. Patient F.K.'s medical records do not document that Respondent performed a physical examination of Patient F.K. during this visit or that he identified the nature and intensity of Patient F.K.’s pain. There is an entry that states the pain is a combination of pathology and depression. No referral is made to any other professional. Respondent also did not document that he discussed the risks and benefits of the use of controlled substances with Patient F.K. 14. On or about April 1, 2002, Patient F.K. presented to Respondent for polyarthritis. The patient was doing water exercises. There was no recorded physical examination or a review of systems. Respondent then prescribed Xanax 2 mg. #90, Methadone 10 mg. #240, 2 q6h (every six hours), and Dilaudid 4 mg. #180, 2 q8h (every eight hours). There is also an entry that a pharmacist called to discuss and confirm the medications prescribed. 45. On or about April 29, 2002, Patient F.K. presented to Respondent. An entry in the report indicates that the patient will try to get his X-ray report that was done while in prison apparently in early 2000. The only other note is a recorded weight and that $75.00 was paid. There is no documented physical examination or review of systems. Respondent then prescribed Xanax 2 mg. #90, Methadone 10 mg. #240 and Dilaudid 4 mg. #180. 16. On or about May 25, 2002 (a Saturday), Patient F.K. returned to Respondent's office. Respondent noted that the patient was recently incarcerated and could not persist in his efforts to get the X-rays from prison. There is no documented physical examination or review of systems. Respondent recommended continued water exercises with Glucosomine and Chrondroiton. Respondent then prescribed Xanax 2 mg. #90, Methadone 10 mg. #240 and Dilaudid 4 mg. #90. Respondent then ordered X-rays for the right knee and back ASAP. 17. On or about May 26, 2002, Patient F.K. died. According to the Broward County Medical Examiner's report, the cause of Patient F.K.’s death was acute -bronchopneumonia due to combined drug toxicity (cocaine and methadone). COUNT ONE 18. Petitioner realleges and incorporates paragraphs one (1) through seventeen (17) as if fully set forth herein. 19. Section 458.331(1)(t), Florida Statutes (2001), provides that 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 constitutes grounds for disciplinary action by the Board of Medicine. 20. Respondent practiced medicine below the acceptable standard of care in one or more of the following ways: a) b) c) d) e) By failing to adequately address the etiology of Patient | FK/s pain; By prescribing controlled substances to Patient FK. | without adequate medical justification; By failing to adequately identify or recommend a treatment plan for Patient FK., particularly concerning the prescribing of controlled substances; By failing to perform adequate physical examinations and/or review of systems of Patient FK.; By failing to refer Patient FK. to a pain management specialist, psychiatrist or other appropriate specialist; 10 f) By failing to follow the guidelines adopted by the Board of Medicine for the use of controlled substances for the treatment of pain; g) By failing to order or obtain X-rays for Patient RK. before continuing to prescribe pain medications. 21. Based on the foregoing, Respondent has violated Section 458.331(1)(t), Florida Statutes (2001), by committing gross malpractice or 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 22. Petitioner realleges and incorporates paragraphs one (1) through seventeen (17) as if fully set forth herein. 23. Section 458.331(1)(m), Florida Statutes (2001), provides that failing to keep medical records that justify the course and scope 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, sets forth grounds for disciplinary action by the Board of Medicine. 11 24. Respondent failed to keep medical records that justify the course of treatment of the patient, in one or more of the following ways: a) By failing to document adequate justification for his continued treatment of Patient EK. with narcotics; b) By failing to document an appropriate treatment plan concerning the narcotics as well as a discussion of proper drug use; c) _ By failing to document adequate physical examinations, reviews of systems and/or the etiology of the back pain; d) By failing to keep adequate progress notes for Patient FK.; e) By failing to comply with Rule 64B8-9.013(3), Florida Administrative Code. 25. Based on the foregoing, Respondent has violated Section 458.331(1)(m), Florida Statutes (2001), by failing to keep legible medical records 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. 12 COUNT THREE 26. Petitioner realleges and_ incorporates paragraphs one (1) through seventeen (17) as if fully set forth herein. 27. Section 458.331(1)(q), Florida Statutes (2001), provides that 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 (inappropriately or in excessive or inappropriate quantities) sets forth grounds for disciplinary action by the Board of Medicine. 28. 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 one or more of the following ways: a) By prescribing, inappropriately or in excessive or inappropriate quantities, controlled substances, including but not limited to, Dilaudid, Methadone, and Xanax to Patient FK.; | b) By prescribing Methadone, Dilaudid and Xanax without an adequate medical justification; 13 c) By continuing to prescribe controlled substances to Patient EK. without adequate medical justification, after learning that Patient FK. could not obtain his X-rays from the prison. 29, Based on the foregoing, Respondent violated Section 458.331(1)(q), Florida Statutes (2001), 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 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. CASE # 2002-26341 - PATIENT A.C. CASE + £UV 2-2 eee 30. On or about March 13, 2001, Patient A.C, a 43 year-old male, first presented to Respondent. Respondent notes in his record that he questioned a loss of medications and that the patient is to return with X-rays. 14 31. On or about March 19, 2001, Patient A.C. returned to Respondent's office with his X-rays. Respondent notes that the X-rays are indicative of significant advanced lumbar disc disease. The recorded history also notes a motor vehicle accident on February 3, 2000. Respondent noted a complaint of pain in the lumbar region radiating to both thighs, left greater than right. Respondent gave Patient A.C. samples of HCTZ (hydrochlorothiazide, an anti-hypertensive), and prescribed Oxycontin 80 mg./60 mg. and Xanax 2.0 mg. bid (twice daily). Respondent started the patient on Tevetan, an anti-hypertensive, 600 mg. daily. Laboratory studies were also ordered. 32. Respondent's medical record of March 19, 2001, also contains a note that a pharmacy advised Respondent that the patient was “on Oxycontin 40 mg. before.” Respondent notes in his record that the patient was given Oxycontin 160 #116 on March 14, 2001, and Oxycontin 40 mg. plus 20 mg., 1 tab TID (three times a day) on February 17, 2001, and references two doctors names. 33. Oxycontin is a legend drug as defined by Section 465.003(8), Florida Statutes, and contains oxycodone, a Schedule II controlled substance listed in Chapter 893, Florida Statutes. Oxycodone is a narcotic 15 analgesic indicated for the relief of moderate to moderately severe pain, and carries a high potential for abuse, and abuse of the substance may lead to severe physical and psychological dependence. 34. Xanax is a legend drug as defined by Section 465.003(8), Florida Statutes, and contains alprazolam, a Schedule IV: controlled substance listed in Chapter 893, Florida Statutes. Alprazolam is a benzodiazepine anxiolytic, and the abuse of alprazolam can lead to . physical and psychological dependence. Xanax is indicated for the short- term relief of symptoms of anxiety. It produces additive CNS (Central Nervous System) depressant effects when co-administered with other CNS depressants. 35. On or about March 21, 2001, Patient A.C. returned to Respondent. There are no notes concerning a physical examination or review of systems. Respondent then prescribed Oxycontin 80 mg, 1 tab qid (four times daily) #120 with a note that he is to “continue on Methadone.” There is also a note about a pending evaluation with no details concerning the proposed evaluation. The record also contains a note that the next appointment is April 4, 2001. 16 36. Respondent's medical records also contain a dated entry of March 19, 2001, that lists the patient’s medications on this date as HCTZ 25 mg. daily, Tevetan 600 mg. daily, Norvasc 5 ma, 2 daily, Xanax 2 mg. bid, and Oxycontin 80 mg. bid. 37. Patient A.C’s records do not reflect that Respondent attempted to obtain Patient A.C.’s past medical records in order to verify Patient A.C’s reported injuries and medical history. . Respondent did not document a treatment plan for Patient A.C. other than to order or request lab work. 38. On or about April 1, 2001, in the morning, members of the Davie Police Department were called to Patient A.C’s home. According to his wife, Patient AC. had been shooting cocaine and taking Xanax and ) Oxycontin all night long. Patient A.C. had stripped himself nude, grabbed some kitchen knives and began swinging them around. Patient A.C. left his residence and went to a neighbor's home. Patient A.C. suffered self- inflicted wounds all over his body and had an altercation with a neighbor. 39. On or about April 1, 2001, in the morning, the police officers located Patient A.C. in the neighbor’s home. Patient A.C. was acting erratic and charged the officers. The police officers restrained Patient A.C. and, 17 shortly after, Patient A.C. passed out. Patient A.C. was transported to Broward General Hospital where he was pronounced dead at 9:06 a.m. 40. On April 2, 2001, the Broward County Medical Examiner conducted an autopsy of the body of Patient A.C. The medical examiner ruled that the cause of Patient A.C’s death was accidental cocaine excited delirium and Oxycodone toxicity. The toxicology report indicated the following drugs were detected in Patient A.C’s body: Benzoylecgonine, Cocaine, Ecgonine Methylester and Oxycodone. , COUNT FOUR 41. Petitioner realleges and incorporates paragraphs one (1) through five (5) and paragraphs thirty (30) through forty (40) as if fully set forth herein. 42. Section 458.331(1)(t), Florida Statutes (2001), provides that 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 constitutes grounds for disciplinary action by the Board of Medicine. | 43. Respondent practiced medicine below the acceptable standard of care in one or more of the following ways: 18 a) b) c) d) e) By failing to create a plan of treatment other than prescribing narcotics; By prescribing drugs to Patient A.C. inappropriately or in inappropriate and excessive amounts, without adequate medical justification; By failing to obtain prior medical records to review past problems and drug use; By _ refilling medications, particularly — controlled substances, without an adequate review of symptoms, adequate examinations, assessments, and/or adequate plans; ; By failing to follow the guidelines adopted by the Board of Medicine for the use of controlled substances for the treatment of pain. 44, Based on the foregoing, Respondent has violated Section 458.331(1)(t), Florida Statutes (2001), by committing gross malpractice or 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. 19 COUNT FIVE 45. Petitioner realleges and incorporates paragraphs one (1) through five (5) and paragraphs thirty (30) through forty (40) as if fully set forth herein. 46. Section 458.331(1)(m), Florida Statutes (2001), provides that failing to keep medical records that justify the course and scope 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, sets forth grounds for disciplinary action by the Board of Medicine. 47. Respondent failed to keep medical records that justify the course of treatment of the patient, in one or more of the following ways: a) __ By failing to document the patient's complete history of the present illness, adequate physical examinations, and/or an assessment of the etiology of the patient's pain; . . b) By failing to document that he discussed the risks and benefits of the use of controlled substances with the patient; 20 ¢) _ By failing to document an adequate treatment plan; d) By failing to document justification for the continued treatment with controlled substances; e) By failing to comply with Rule 64B8-9.013(3), Florida Administrative Code. 48. Based on the foregoing, Respondent has violated section . 458.331(1)(m), Florida Statutes (2001), by failing to keep legible medical records 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. ‘COUNT SIX 49. Petitioner realleges and incorporates paragraphs one (1) through five (5) and paragraphs thirty (30) through forty (40) as if fully set forth herein. | 50. Section 458.331(1)(q), Florida Statutes (2001), provides that 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 (inappropriately or in excessive or 21 inappropriate quantities) sets forth grounds for disciplinary action by the Board of Medicine. 51. 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 one or more of the following ways: a) By prescribing, inappropriately or in excessive or inappropriate quantities, controlled substances, including but not limited to, Xanax, and Oxycontin to Patient A.C.; b) By prescribing a_ significant amount of controlled substances to Patient A.C. after discovering that the patient obtained pain medication from another physician approximately four days before seeing Respondent. 52. Based on the foregoing, Respondent violated Section 458.331(1)(q), Florida Statutes (2001), 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 22 preparing a legend drug, including 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. WHEREFORE, the 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 the Respondent on probation, corrective action, remedial education and/or any other relief that the Board deems appropriate. SIGNED this qe day of (alow, —__, 2004. hn O. Agwangpi, M.D., M.B.A. Se reany epartmert of Health FILED S DEPARTMENT OF HEALT DEPUTY CLERK K Joh, E. Terrel, Assistant General Counsel CLERK Niadhin Coleman Prosecution Services Unit oare__alaslod 4052 Bald Cypress Way, Bin C-65 Tallahassee, FL 32399-3265 Florida Bar # 0865036 (850) 414-8126; (850) 414-1989 FAX JET/tgc Reviewed and approved by: Ve (initials) (date) Pcp: 2]23/oe04 PCP Members: €1-Babet ne Coy ; Dychee Jerome F. Waters, M.D.; DOH Case Numbers 2002-26339 and 2002-26341 23 Jerome F. Waters, M.D. DOH Case Numbers 2002-26339 and 2002-26341 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. 24

Docket for Case No: 04-000869PL

Orders for Case No: 04-000869PL