STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, Petitioner, Vv. Case No. 2009-24320 KENNETH A. BERDICK, M.D., Respondent. ee, | 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 the Respondent, Kenneth A. Berdick, M.D., hereinafter referred to as “Respondent,” and in support thereof alleges: 1. Petitioner is the state agency 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 in the state of Florida, having been issued license number ME 17772. 3. | Respondent's address of record is 2665 Cleveland Avenue, Suite 108, Ft. Myers, Florida 33901. 4. Respondent is Board Certified in Internal Medicine. GENERAL ALLEGATION Applicable Rule 5. | The version of Rule 64B8-9.013(3), Standards for the Use of Controlled Substances for the Treatment of Pain, Florida Administrative Code, that was in effect at all times material to this complaint provided: (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 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. (b) 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 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. (c) 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 patlent 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 should 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). (d) 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 the patient’s progress. 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. (e) 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 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 medical history and physical examination, including history of drug abuse or dependence, as appropriate, Diagnostic, therapeutic, and laboratory resuiles 3. Evaluations and consultations; 4. Treatment objectives; 5. — Tiscussion 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. Records must remain current and be maintained in an accessible manner and readily available for review. FACTS RELATED TO PATIENT WM 6. From January of 2006 until July 16, 2009, Patient WM, a then 23 year-old female, presented to Respondent as her primary care physician. In addition to treating WM for general health issues, Respondent also treated WM for chronic low back pain and chronic anxiety. 7. On or about January 29, 2008, WM presented to Respondent with complaints of continued anxiety and back pain. At the time, a pain management physician was managing WM’s back pain. Respondent prescribed 60 dosage units of Xanax 1.0 mg. 60 tablets, to treat her anxiety and Celebrex to treat her back pain. Respondent also treated the patient’s back pain with an injection of Prednisolone. Respondent ordered cervical and lumbar spine x-rays of the patient's back. — 8. Alprazolam (brand name Xanax) is prescribed to treat anxiety. According to Section 893.03(4), Florida Statutes, 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, and abuse of the substance may lead to limited physical or psychological dependence relative to the substances in Schedule ITI. 9. Celebrex is a legend drug prescribed to manage adult pain, osteoarthritis and rheumatoid arthritis. 10. Prednisolone Is a steroid used to treat Prednisolone is used to treat many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders. 11. The lumbar and cervical x-rays revealed nothing significant regarding WM’s back pain. 12. On or about February ii, 2008, WM’s pain management physician notified Respondent that he had dismissed her from his practice because he thought WM was having “some issues with diversion” based on her urine drug screens which did not match the prescriptions that Respondent or the pain management physician were prescribing. The pain mahagement physician recommended that WM enter an Inpatient drug treatment program. 13. Regardless, beginning on or about January 29, 2009, and continuing until July 16, 2009, Respondent regularly prescribed 60 dosage units of Xanax 1.0 mg. for WM’s anxiety and 60 dosage unlts of Vicodin ES. | 14. Hydrocodone with acetametaphine (brand name Vicodin) is used to treat pain. According to Section 893.03(4), Florida ‘Statutes, hydrocodone with acetametaphine is 4 Schedule IV controlled substance that has a low potential for abuse relative to the substances in Schedule ITI and has a currently accepted medical use in treatment in the United States, and abuse of the substance may lead to limited physical or psychological dependence relative to the substances in Schedule IIT. 15. On several occasions, WM presented several days early for her appointment because she had run out of her medication. Respondent ordered refills of the prescriptions and added a nonsteroidal anti- inflammatory drug for her back pain. 16. On or about May 26, 2009, Respondent added a prescription for Doxepin to WM‘s medication. There is no explanation in the medical records documenting why WM needed additional medication or why Respondent decided to add the drug. 17. Doxepin is a psychotherapeutic legend drug that Is used to treat depression and anxiety. 18. On or about May 27, 2009, WM presented to Respondent and reported that her Vicodin and Xanax had been stolen. Respondent wrote her prescriptions for 60 dosage units of Tylenol IV and Xanax. 19. On or about June 20, 2009, Patlent WM presented to Respondent a week early for her routine office visit and reported that she would like to have her Vicodin prescription refilled because the Tylenol IV upset her stomach. 20. Respondent refilled WM's prescription for Vicodin and Xanax. 21. On or about July 16, 2009, WM presented to Respondent, again several days early for her appointment with little explanation of why she needed her medication early. Respondent wrote refills for Vicodin, Xanax and Doxepin. 22. During the period from January of 2006 until July 16, 2009, Respondent's medical records do not document the nature and intensity of WW’s pain, the effect of the pain on physical and psychological function or anything regarding the patient’s history of substance abuse. The medical records contain no documentation of the presence of an adequate medical indication for Respondent to prescribe the prolonged use of controlled substances. | 23. Respondent’s assessment of WM varied from cervicalgia, lumbago, chronic back pain and sacroiliitis. The medical records contain no diagnostic explanation for any of these diagnoses. Regardless of the assessment, Respondent prescribed the same medication. . 24. Respondent did not create a written treatment plan for WM that stated objectives to determine the success of treatment with controlled substances. 25. Respondent did not order or document discussion with WM about the risks of long-term use of controlled substances. Respondent did not enter into a written agreement with Patient WM setting out clearly what her responsibilities were in regard to medication abuse even though her pain management specialist had dismissed her as a patient for questionable urine drug screens and she regularly requested early refills of her controlled substance prescriptions. 26. Even after being notified by WM’s pain management physician of the questionable results of WM's drug screens, Respondent did not order drug screens for WM to insure that she was not abusing medication. 27. Respondent did not refer Patient WM to a specialist to pursue determination of the etiology of her back pain and he did not refer her to a psychiatrist for consultation regarding her chronic anxiety. 28. On or about July 27, 2009, WM died due to acute poly drug intoxication, alprazolam, hydrocodone and oxycodone. 29. The prevailing standard of care required Respondent to pursue determination of the etiology of WM's chronic back pain and to refer her to a psychiatrist for consultation regarding her chronic anxiety. : 30. The orevelling standard of care required Respondent to counsel WM regarding the risks of prolonged use of controlled substances for the treatment of pain given her dismissal by her pain management physician and her repeated requests for early refills. 31. The prevailing standard of care required that Respondent create a treatment plan for WM that provided a methodology for determining the success of long-term treatment with controlled substances and consideration of other treatment modalities. 32. The prevailing standard of care required that Respondent determine that WM was at high risk for medication abuse and order dng screens for WM to insure that she was not abusing medication or other controlled substances. COUNT ONE 33. Petitioner realleges and incorporates by reference the allegations in paragraphs one (1) through thirty-two (32) as if fully set forth herein. 34. Section 458.331(1)(t)1, Florida Statutes (2007-2008), subjects a physician to discipline for committing medical malpractice as defined in Section 456.50, Florida Statutes (2007-2008). “Medical malpractice” is defined by Section 456.50(1)(g), Florida Statutes (2007-2008), 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 (2007-2008), provides that the 10 “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(1), Florida Statutes (2007-2008), 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. 35. Section 458.331(1)(t)1, Florida Statutes (2007-2008), directs the Board of Medicine to give “great weight” to this provision of Section 766.102, Florida Statutes (2007-2008). 36., During 2008 and until July of 2009, Respondent failed to meet the prevalling standard of care by failing to do one or more of the following in the treatment of Patient WM: a. By failing to perform a complete medical history and physical examination; b. By failing to create a treatment plan with objectives to determine the success of the treatment of the patient; 7 c. By failing to establish sound clinical grounds to justify the need for the controlled substances he prescribed; 11 d. By failing to monitor WM for medication abuse after her pain management physician raised the issue and by failing to monitor her medication levels; e. By failing to order drug screens to insure that WM was not abusing’ controlled substances given her questionable history of possible medication abuse; and f. By failing to refer WM for additional evaluations and consultations for treatment for pain and anxiety; and g. By failing to comply with the requirements of Rule 64B809.013, Florida Administrative Code, given the patient’s history and behavior indicating that she was at high risk for medication abuse. 37. Based on the foregoing, Respondent failed to meet the prevailing standard of care and, therefore, violated Section 458.331(1)(t)1, Florida Statutes (2007-2008). COUNT TWO — IN THE ALTERNATIVE TO COUNT ONE 38. Petitioner realleges and incorporates by reference the allegation In paragraphs one (1) through thirty-three (33) and paragraph thirty-six (36) as if fully set forth herein. 12 39. Section 458.331(1)(m), Florida Statutes (2007-2008), subjects a licensee to discipline for failing to keep legible, as defined by department rule in consultation with the board, 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. 40. Respondent failed to keep legible medical records that justified Respondent's course of treatment of Patient WM, specifically, by failing to document one or more of the following: a. By falling to document the performance of a complete medical history and physical examination; b. By failing to document the ereatan of a written treatment plan with objectives to determine the success of the treatment of the patient; c. By failing to document any history related to drug abuse or dependence and by failing to document monitoring of her medication levels; d. By failing to document the referral of Patient WM for additional evaluations and consultations for treatment after her pain and anxiety continued; e. By failing to keep legible medical records that justify the course of treatment for WM; and f. By failing to comply with the requirements of Rule 648809.013, Florida Administrative Code, pertaining to documentation, given the patient's history and behavior indicating that she was at high risk for medication abuse. 41. Based on the foregoing, Respondent violated Section 458.331(1)(m), Florida Statutes (2007-2008). FACTS RELATED TO PATIENT GP 42. From on or about January 25, 2007, through August of 2008, Patient GP, a then 62 year-old male, presented to Respondent as his primary care physician. In addition to treating GP for general health issues, Respondent also treated Patient GP for chronic significant mental health issues and pain. Respondent's medical records indicate that the January 25, 2007, office visit was not Patient GP’s first but Respondent has no medical records documenting previous treatment by Respondent. 14 43. From on or about January 27, 2007, through August of 2008, Respondent's medical records indicate that Respondent assessed GP with attention deficit disorder (ADD), bipolar syndrome, schizophrenia, osteoarthritis and diabetes. Respondent's records contain no documentation regarding the basis of Respondent's diagnosis of ADD. 44. From on or about January 27, 2007, through August of 2008, Respondent prescribed either Adderall or Ritalin at the patient’s request. In addition, Respondent prescribed Cogentin, Tylenol No. 4, Xanax, and Ambien for GP. 45. Adderall (amphetamine and dextroamphetamine salts) is used for treating attention deficit hyperactivity disorder (ADHD) and narcolepsy. Side effects of Adderall include nervousness, restlessness, excitabllity, dizziness, headache, fear, anxiety, and tremor. Adderall may induce psychosis or exacerbate psychosis. 46. Ritalin (methylphenidate) is a central nervous system stimulant. Ritalin affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control. Ritalin is used to treat attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD). It is also used in the treatment of a sleep disorder called narcolepsy (an uncontrollable desire to sleep). When given for attention deficit disorders, Ritalin should be an integral part of a total treatment program that may include counseling or other therapies. 47, Cogentin is a legend drug that is used to control tremors and - stiffness of the muscles due to certain antipsychotic medicines. 48. Tylenol #4 is Tylenol with codeine #4 (acetaminophen, codeine 60 mg). Tylenol #4 is prescribed to treat pain. According to Section 893.03(3), Florida Statutes, codeine, in the dosages found in Tylenol #4, is a Schedule III controlled substance that has a potential for abuse less than the substances in Schedules I and II and has a currently accepted medical use in treatment in the United States, and abuse of the substance may lead to moderate or. low physical dependence or high psychological dependence. 49. Zolpidem (brand name Ambien) is a benzodiazepine and is prescribed to treat insomnia. According to Title 21, Section 1308.14, Code of Federal Regulations, zolpidem is a Schedule IV controlled substance. Zolpidem can cause dependence and is subject to abuse. 50. | In September of 2007, GP was hospltalized with chest pains and “exacerbation of schizophrenia.” A hospital psychiatrist diagnosed GP 16 with “acute altered mental status, schizophrenia” and prescribed several medications during GP’s several week hospitalization. The medications prescribed to GP during his hospitalization were Zyprexa, an atypical antipsychotic medication, Abilify, an antipsychotic medication, Bentropine, medication used to treat side effects of antipsychotic medication, Haldol, an antipsychotic medication, Ativan, a benzodiazepine used to treat anxiety, Seroquel, a psychotropic medication used to treat schizophrenia and depression and Depakote, used to treat manic episodes related to bipolar disorder. These are all drugs appropriately prescribed to treat an acute altered mental status and to treat schizophrenia. 51. On or about January 10, 2008, GP returned to Respondent for a follow-up visit. GP indicated that he had not been on Ritalin for several months and requested that Respondent give him a prescription for the drug. Respondent wrote a prescription for 20 mg Ritalin-SR tablets to be taken twice a day. 52, However, on or about January 24, 2008, GP presented to Respondent for follow-up. Respondent's records do not indicate that GP was taking or prescribed any medication to treat schizophrenia or bi-polar disorder even though the records from GP’s previous visit indicate that 17 Respondent was aware of the medication GP had been prescribed and of his diagnosis. Respondent prescribed Ritalin and Ambien for GP. 53. On or about February 8, 2008, Respondent noted that the patient was agitated and disorganized and Respondent attributed that to GP’s ADD. Once again, the records contain no documentation regarding GP's medication for schizophrenia or bi-polar disorder. 54. Respondent prescribed Ritalin for GP’s ADD, and 30 dosage units of Tylenol IV. Respondent's records document that GP was taking .5mg of Xanax but there is no prior documentation of Respondent prescribing Xanax. 55. In February of 2008, GP was diagnosed with coronary artery disease by a cardiologist. 56. On or about April 4, May 7, June 4; June 2, 2008, GP presented to Respondent for follow-up and Respondent prescribed Ritalin, an undocumented quantity of Xanax, Tylenol IV and an undocumented quantity of Ambien. The medical records contain no meaningful pain assessment or discussion about the effects of Ritalin or the status of the patient's schizophrenia. 57. On or about July 18, 2008, GP presented to Respondent for follow-up. Respondent prescribed 60 dosage units of 20 mg tablets of | Adderall to be taken twice a day. | | 58. _On or about August 6, 2008, GP presented to Respondent before he was scheduled for an appointment. GP requested early refills for his medication and Respondent wrote him prescriptions for 30 dosage units of Tylenol IV, 60 dosage units of 20 mg Adderall, and 60 dosage units of .5 mg of Xanax. 59. Onor about August 13, 2008, GP died. The cause of death was acute amphetamine toxicity. 60. The prevailing standard of care required Respondent not to prescribe Adderall or Ritalin to a patient with a diagnosis of schizophrenia. 61. The prevailing standard of care required Respondent to consult with or refer GP to a specialist for the monitoring of antipsychotic medication and before prescribing Ritalin, Adderall and Xanax to a patient ‘with GP's history. COUNT THREE 62. Petitioner realleges and incorporates by reference the allegations In paragraphs one (1) through five (5) and forty-two (42) through sixty-one (61) as if fully set forth herein. 63. Section 458.331(1)(t)1, Florida Statutes (2007-2008), subjects a physician to discipline for committing medical malpractice as defined in Section 456.50, Florida Statutes (2007-2008). “Medical malpractice” is defined by Section 456.50(1)(g), Florida Statutes (2007-2008), 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 (2007-2008), 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(1), Florida Statutes (2007-2008), which states as follows: The prevalling 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. 20 64. Section 458.331(1)(t)1, Florida Statutes (2007-2008), directs the Board of Medicine to give “great weight” to this provision of Section 766.102, Florida Statutes (2007-2008). 65. Between September 2007 and August of 2008, Respondent failed to meet the prevailing standard of care by doing one or more of the following in the treatment of Patient WM: a. By prescribing Adderall and Ritalin to a patient with a diagnosis of schizophrenia and/or bi-polar disorder; b. By failing to consult with or refer GP to a specialist for the prescribing and monitoring of antipsychotic medication and before replacing the previously prescribed drugs with Ritalin, Adderall and Xanax; ‘c. __ By failing to establish sound clinical grounds to justify the need for the therapy he prescribed; and | | d. By failing to monitor GP for medication abuse and by failing to monitor his medication levels; and e. By failing to comply with the requirements of Rule 64B809.013, Florida Administrative Code, given the patient's mental health issues, 2007-2008 24 66. Based on the foregoing, Respondent falled to meet the prevailing standard of care and, therefore, violated Section 458.331(1)(t)1, Florida Statutes (2007-2008). COUNT FOUR — IN THE ALTERNATIVE TO COUNT THREE 67. Petitioner realleges and incorporates by reference the allegations in paragraphs one (1) through five (5) and paragraph forty-two (42) through sixty-one (61) and paragraph sixty-six (66) as if fully set forth herein. 68. Section 458.331(1)(m), Florida Statutes (2007-2008), subjects a licensee to discipline for failing to keep legible, as defined by department rule in consultation with the board, medical records that justify the course of treatment of the patient, including, but not limited to, patient historles; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations. 69. Respondent failed to keep legible medical records that justified Respondent's course of treatment of Patient GP, specifically, by falling to document one or more of the following: a. _ By falling to document the performance of a complete medical history and physical examination; 22 b. By failing to document the creation of a written treatment plan with objectives to determine the success of the treatment of the patient; c. By failing to document any clinical basis for not prescribing antipsychotic medication and for prescribing Adderall and Ritalin to a patient who had been diagnosed with schizophrenia and d. By failing to monitor GP’s medication levels; e. By failing to document the referral of Patient GP for additional evaluations and consultations for treatment of his schizophrenia; f. By failing to keep legible medical records that justify the course of treatment to GP; and g. By failing to comply with the requirements of Rule 64B809,013, Florida Administrative Code, pertaining to documentation. 70. Based on the foregoing, Respondent violated Section 458.331(1)(m), Florida Statutes (2007-2008). FACTS RELATED TO PATIENT LJIW 71. Between January of 2006 and June 13, 2008, Patient LW oy to Respondent as her primary care physician. In addition to treating LIW for general health issues, Respondent also treated LW for long term depression, anxiety and chronic complaints of neck and back pain. Although Respondent has no medical records for 2006, a Master Medication sheet documents that Respondent prescribed medication for LIW throughout 2006. 72. On or about February 20, 2007, LIW presented to Respondent for follow-up. Respondent’s medical records indicate that Respondent was treating LIW for cervicalgia (neck pain) with spinal stenosis and spondylosis, depression, vertigo, hypertriglyceridemia and anxiety. At the time she presented, Respondent had previously prescribed Paxil, Tramadol, Alprazolam and Darvocet to UW 73. Paxil is a legend drug that is used to treat depression. 74, Tramadol (brand name Ultram) Is an opioid class medication prescribed to treat pain. Tramadol is a legend drug, but not a controlled substance. Tramadol, like all opioid class drugs, can affect mental alertness, is subject to abuse, and can be habit forming 75. Darvocet is the brand name for a drug that contains propoxyphene and is prescribed to treat pain. According to Section 893.03(4), Florida Statutes, propoxyphene is a Schedule IV controlled substance that has a low potential for abuse relative to the substances in 24 Schedule III and has a currently accepted medical use in treatment in the United States, and abuse of the substance may lead to limited physical or psychological dependence relative to the substances In Schedule IIT. 76. From on or about February 23, 2007, through October 3, 2007, LOW presented to Respondent for regular follow-up visits. On several occasions, Respondent administered Prednisolone injections to UW. Respondent routinely refilled LIW’s prescriptions for 90 dosage units of Darvocet, and 60 dosage units of alprazolam .5mg. 77. On or about November 5, 2007, LIW presented to Respondent for follow-up. Respondent documented that LIW was under “a lot of stress lately.” Although his records indicate that the patient’s “depression/anxiety Stable”, Respondent added a prescription of 30 dosage units of 30 mg Temazepam to her existing prescriptions of Paxil, tramadol, alprazolam, and Darvocet. 78. Temazepam (a benzodiazepine) is prescribed to treat insomnia and anxiety. According to Section 893.03(4), Florida Statutes, temazepam 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, and abuse of temazepam 25 may lead to limlted physical or psychological dependence relative to the substances in Schedule ITI. 79. On - about November 16, 2007, LJW presented to Respondent for follow-up. Respondent's medical records indicate that LJW stated that in addition to the medication Respondent had prescribed, she also had Ambien that she used for sleeping. 80. In December of 2007, January, February, and April of 2008, bw presented to Respondent for follow-up and medication refills. 81. On or about April 21, 2008, LW presented to Respondent for follow-up and medication refills. Respondent's records indicate that he “would like to cut down the Darvocet” but LIW indicated “not yet.” Respondent refilled her prescriptions and added a prescription for 30 dosage units of Klonopin .5mg. Respondent’s medical records do not contain any explanation or justification for the Klonopin prescription. 82. Clonazepam (brand name Klonopin) is a benzodiazepine. Clonazepam is commonly prescribed to treat anxiety. According to Section 893.03(4), Florida Statutes, clonazepam 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 26 United States, and abuse of clonazepam may lead to limited physical or psychological dependence. 83. On or about June 13, 2008, Patient LIW presented to Respondent for follow-up. Respondent's medical records indicate that LW had a potential DUI charge pending. Respondent wrote refills for alprazolam, Klonopin and Darvocet, in addition to LIW’s prescriptions for Paxil and Temazepam. 84. Respondent did not prescribe alternative or additional methods of treating LIW's pain, depression or anxiety other than long-term use of controlled substances. 85. Respondent did not refer LIW for diagnostic testing to determine the etiology of her pain or refer her to a psychiatrist for consultation and treatment of her chronic anxiety and depression. 86. Respondent did not create a written treatment plan or method of assessing the success of LIW’s treatment with controlled substances. 87. Respondent failed to monitor W's compliance of medication usage and repeatedly referred to her “requests” regarding prescriptions and refusals in regard to reduction of medication or diagnostic testing. 27 88. On or about June 14, 2008, Patient LIW died as a result of acute alprazolam toxicity. 89. The prevailing standard of care required Respondent to pursue a determination of the etiology of Patient LIW’s chronic neck and back pain or refer her for further evaluation or consultation. 90. The prevailing standard of cared required Respondent to refer LIW to a psychiatrist for consultation regarding her chronic depression and anxiety. 91. The prevailing standard of care required Respondent to counsel Patient LW regarding the risks of prolonged use of controlled substances for the treatment of pain and anxiety in light of her repeated requests for refills. 92. The prevalling standard of care required that Respondent create a treatment plan for Patient LIW that provided for some methodology for determining the success of long-term treatment with controlled substances and consideration of other treatment modalities. 28 COUNT FIVE 93. Petitioner realleges and incorporates by reference the allegations in paragraphs one (1) through five (5) and seventy-one (71) through ninety-two (92) as if fully set forth herein. 94. Section 458.331(1)(t)1, Florida Statutes (2007), subjects a physician to discipline for committing medical malpractice as defined in Section 456.50, Florida Statutes (2007). “Medical malpractice” is defined by Section 456.50(1)(g), Florida Statutes (2007), as “the fallure 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 (2007), 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 specifled in Section 766.102(1), Florida Statutes (2007), 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. 29 95. Section 458.331(1)(t)1, Florida Statutes (2007), directs the Board of Medicine to give “great weight” to this provision of Section 766.102, Florida Statutes (2007). 96. Respondent failed to meet the prevailing standard of care by falling to do one or more of the following in the treatment of Patient LW: a. By failing to perform a complete medical history and physical examination; b. By failing to create a treatment plan with objectives to determine the success of the treatment of the patient; c. By failing to establish sound dinical grounds to justify the need for the therapy he prescribed; d. __ By failing to monitor IW for medication abuse by failing to monitor her medication levels; e. By failing to refer for IW for additional evaluations and consultations for treatment for pain, depression and anxiety; and f. By ‘failing to comply with the requirements of Rule 64B809.013, Florida Administrative Code. 30 97. Based on the foregoing, Respondent failed to meet the prevailing standard of care and, therefore, violated Section 458.331(1)(t)1, Florida Statutes (2007). COUNT SIX — IN THE ALTERNATIVE TO COUNT FIVE 98. Petitioner realleges and incorporates by reference the allegations in paragraphs one (1) through five (5) and paragraph seventy- one (71) through ninety-two (92) and paragraph ninety-six (96) as if fully set forth herein. 99. Section 458.331(1)(m), Florida Statutes (2007), subjects a licensee to discipline for falling to keep legible, as defined by department rule in consultation with the board, 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. 100. Respondent failed to keep legible medical records that justified Respondent's course of treatment of Patient LIW, specifically, by failing to document one or more of the following: a. By failing to document the performance of a complete medical history and physical examination; 31 b. By failing to document the creation of a written treatment plan with objectives to determine the success of the treatment of the patient; c. By failing to document monitoring of her medication levels; d. By failing to document the referral of Patient LIM for additional evaluations and consultations for treatment of her chronic pain, anxiety and depression; | e. By failing to keep legible medical records that justify the course of treatment for LIM; f. By failing to comply with the requirements of Rule 64B809.013, Florida Administrative Code, regarding documentation. 101. Based on the foregoing, Respondent violated Section 458.331(1)(m), Florida Statutes (2007). FACTS RELATED TO PATIENT MAP 102. Between January 26, 2007 and August 8, 2008, Patient MAP presented to Respondent as his primary care physician. In additlon to treating MAP for general health issues, Respondent also treated MAP for 32 long term depression, anxiety and chronic pain generally related to his back. 103. Respondent routinely treated MAP’s back pain with 84 drug dosage units of Darvocet and periodic Prednisolone and Xylocaine injections and his depression with Paxil. 104. In March of 2007, Respondent added a prescription for 30 dosage units of alprazolam .5 mg to MAP’s prescribed medications. 105. During the above period of time, MAP presented early for his prescription refills and he attempted to obtain additional refills at the pharmacy. 106. On or about August 8, 2008, MAP presented to Respondent for follow-up. At that time, MAP reported increased anxiety and depression. The patient requested an increase in the number of alprazolam and asked for his Paxil to be Increased from 20 mg to 40 mg. Respondent prescribed the medication as requested by the patient and continued MAP’s prescription for Darvocet.. 107. On or about September 15, 2008, MAP died due to a poly drug overdose of propoxyphene (Darvocet) and Xanax Intoxication. 33 108. Respondent did not pursue or document the determination of the etiology of MAP’s pain, he did not refer or document the referral of the patient for diagnostic testing and he did not refer or document the patient to a psychiatrist for his chronic anxiety and increasing depression. 109. Respondent failed to create and document a written treatment : plan or a method of assessing the success of MAP’s treatment with long- term use controlled substances, 110. Respondent repeatedly complied with MAP’s “requests” regarding prescriptions and failed to assess the patient as high risk for substance or medication abuse given his repeated requests for early refills » of his medication and his increasing depression. | 111. The prevailing standard of care required Respondent to pursue a determination of the etiology of Patient MAP’s chronic pain or refer him for further evaluation or consultation. 112. The prevailing standard of cared required Respondent to refer MAP to a psychiatrist for consultation regarding chronic depression and anxiety. 113. The prevailing standard of care required Respondent to counsel Patient MAP regarding the risks of prolonged use of controlled substances 34 for the treatment of pain and anxiety in light of his repeated requests for refills and his increasing depression. 114. The prevailing standard of care required that Respondent create a treatment plan for Patient MAP that provided a methodology for determining the success of long-term treatment with controlled substances and consideration of other treatment modalities. COUNT SEVEN 115. Petitioner realleges and incorporates by reference the allegations in paragraphs one (1) through five (5) and one hundred two (102) through one hundred fourteen (114) as if fully set forth herein. 116. Section 458.331(1)(t)1, Florida Statutes (2007-2008), subjects a physician to discipline for committing medical fisipreetics as defined in Section 456.50, Florida Statutes (2007-2008). “Medical malpractice” is defined by Section 456.50(1)(g), Florida Statutes (2007-2008), 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 (2007-2008), provides that the “level of care, skill, and treatment recognized in general law related to health 35 care flcensure" means the standard of care that is specified in Section 766.102(1), Florida Statutes (2007-2008), which states as follows: The prevalling 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. 117. Section 458.331(1)(t)1, Florida Statutes (2007-2008), directs the Board of Medicine to give “great weight” to thls provision of Section 766.102, Florida Statutes (2007-2008). 118. From September 2007 until August 2008, Respondent failed to meet the prevailing standard of care by failing to do one or more of the following in the treatment of Patient LW: a. _By failing to perform a complete medical history and physical examination; | b. By failing to create a treatment plan with objectives to determine the success of the treatment of the patient; c. _ By failing to establish sound clinical grounds to justify the need for the therapy he prescribed; d. By falling to refer MAP for additional evaluations and consultations for treatment for pain, depression and anxlety; and 36 e. By failing to comply with the requirements of Rule 64B809.013, Florida Administrative Code. 119. Based on the foregoing, Respondent failed to meet the prevailing standard of care and, therefore, violated Section 458.331(1)(0)1, Florida Statutes (2007-2008). COUNT EIGHT — IN THE ALTERNATIVE TO COUNT SEVEN 120. Petitioner realleges and incorporates by reference the allegations in paragraphs one (1) through five (5), paragraphs one hundred two (102) through one hundred fourteen (114) and paragraph one hundred eighteen (118), as if fully set forth herein. 121. Section 458.331(1)(m), Florida Statutes (2007-2008), subjects a licensee to discipline for failing to keep legible, as defined by department rule in consultation with the board, 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. . 122. Respondent failed to keep legible medical records that justified Respondent's course of treatment of Patient MAP by failing to document one or more of the following: 37 a. By failing to document the performance of a complete medical history and physical examination; b. By faillng to document the creation of a written treatment plan with objectives to determine the success of the treatment: for the patient; c. By falling to document the referral of Patient MAP for additional evaluations and consultations for treatment of his chronic pain and his anxiety and depression; d. _ By failing to keep legible medical records that justify the course of treatrnent for MAP; and e. By failing to comply with the requirements set out in Rule 64B8-9.013, Florida Administrative Code, related to documentation. 123. Based on the foregoing, Respondent violated Section 458.331(1)(m), Florida Statutes (2007-2008). WHEREFORE, the Petitioner respectfully requests that the Board of Medicine enter an order imposing one or more of the following penalties: permanent FaTOeRRON or suspension of Respondent's license, Imposition of an administrative fine, issuance of a reprimand, placement of the Respondent on probation, corrective action, refund of fees billed or 38 collected, remedial education and/or any other relief that the Board deems appropriate. SIGNED this_/o day of_ Ch peepee 2013. FILED DEPARTMENT OF HEALTH DEPUTY CLERK CLERK Angel Sanders paTE AUG 20 2013 CLG PCP Date: B [16 [15 John H. Armstrong, MD, FACS State Surgeon General and Secretary of Health Ciel L Mize Carol L. Gregg Assistant General Counsel DOH Prosecution Services Unit 4052 Bald Cypress Way, Bin C-65 Tallahassee, FL 32399-3265 Florida Bar # 181515 (850) 245-4444 x 8123 PHONE (850) 245-4684 FAX carol_gregg@doh.state.fl.us PCP Members: Avila, Averhoff & Oyches 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 quallfied 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. JAPSU\N

Docket for Case No: 16-003953PL