STATE OF FLORIDA
DIVISION OF ADMINISTRATIVE HEARINGS
)
DEPARTMENT OF HEALTH, BOARD OF ) MEDICINE, )
)
Petitioner, )
)
vs. )
)
JEROME F. WATERS, M.D., )
)
Respondent. )
Case Nos. 04-0400PL
04-0401PL
04-0869PL
)
RECOMMENDED ORDER
Pursuant to notice, a final hearing was held in these consolidated cases on February 8 through 11, 2005, in Miami, Florida, before Administrative Law Judge Michael M. Parrish, of the Division of Administrative Hearings.
APPEARANCES
For Petitioner: John E. Terrel, Esquire
Bernabe A. Icaza, Esquire Department of Health
4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265
For Respondent: Louise T. Jeroslow, Esquire
6075 Sunset Drive, Suite 201
Miami, Florida 33143-5000
STATEMENT OF THE ISSUES
The issues in these three consolidated cases are whether Respondent, Jerome F. Waters, M.D., committed the violations
alleged in three Administrative Complaints filed by Petitioner, the Department of Health, and, if so, what disciplinary action should be taken against him.
PRELIMINARY STATEMENT
On May 29, 2003, two Administrative Complaints were issued against Respondent. Respondent requested evidentiary hearings in both of those cases and on February 3, 2004, both cases were referred to the Division of Administrative Hearings, where they were docketed as DOAH Case Nos. 04-0400PL and 04-0401PL. The Administrative Complaint in DOAH Case No. 04-0400 concerned Department of Health Case No. 2002-12858. The Administrative Complaint in DOAH Case No. 04-0401PL concerned Department of Health Cases Nos. 2002-26340, 2002-26342, and 2002-26343.
On February 25, 2004, a third Administrative Complaint was filed against Respondent. Respondent again requested an evidentiary hearing, and on March 15, 2004, the third case was referred to the Division of Administrative Hearings, where it was docketed as DOAH Case No. 04-0869PL. The Administrative Complaint in DOAH Case No. 04-0869PL concerned Department of Health Cases Nos. 2002-26339 and 2002-26341.
At the request of the Department, the Division of Administrative Hearings consolidated all three cases for final hearing. Following several continuances for several different
reasons, the final hearing in these consolidated cases was held in Miami, Florida, on February 8 through 11, 2005.
At the request of the Petitioner, the Administrative Law Judge took official recognition of the versions of Florida Administrative Code Rules 64B8-8.001, 64B8-9.013(3), and 64B8-
9.003 which were in effect from 1999 through 2002.
During the course of the final hearing, Petitioner's Exhibits of the following numbers were received in evidence: 1, 2, 3, 11,
13, | 14, | 15, | 16, | 17, | 18, | 20, | 21, 24, | 25, 28, 30, 31, | 32, 33, 34, |
36, | 37, | 40, | 41, | 42, | 43, | 44, | 45, 46, | 47, 48, 49, 52, | 53, 54, 55, |
56, | 58, | 59, | 60, | 61, | 64, | and | 65. |
During the course of the final hearing, Respondent's Exhibits of the following numbers were received in evidence: 1, 2, 3, 4, 5,
6, 7, 8, 9, and 19.
At the final hearing Petitioner presented the testimony of
(Mother of Patient D.P.); Okoduwa Okoawo, R.Ph.; Aryan Arayam, R.Ph.; Mark J. Shuman, M.D.; Simone Gregory, L.C.S.W.; Alan J. Yesner, M.D.; Michael Wagner, M.S.; Eroston Price, M.D.; Harold Schueler, Ph.D.; Joshua A. Perper, M.D.; Sophia Alfonso, R.Ph.; Margarita Vicente, R.Ph.; and Sandra Moss, Medicaid Program Administrator.
Respondent testified on his own behalf at the final hearing and also offered the testimony of Jorge De Moya, M.D.
The transcript of the final hearing was filed on February 25, 2005, and consists of six volumes. The parties agreed to file their proposed recommended orders by April 8, 2005. Both parties filed timely Proposed Recommended Orders containing proposed findings of fact and conclusions of law. These proposals have been carefully considered during the preparation of this Recommended Order.
FINDINGS OF FACT
The Parties
Petitioner, the Department of Health (hereinafter referred to as “Petitioner” or “Department”), is the agency of the State of Florida charged with the responsibility for the investigation and prosecution of complaints involving physicians licensed to practice medicine in Florida.
Respondent, Jerome F. Waters, M.D. (hereinafter referred to as “Respondent”) is, and has been at all times material to these consolidated cases, a physician licensed to practice medicine in Florida, having been issued license number ME 7236.
Respondent graduated from New York University Medical school 48 years ago and did four years of a general surgical residency. He is not board-certified although he is board eligible in general surgery.
Respondent had only one medical malpractice lawsuit against him and that was in 1964. The Administrative Complaints in these consolidated cases are the first license discipline cases against Respondent.
Respondent has had a long and distinguished medical career. He has been in private practice in Miami, Florida, since 1961 and he has been at the same location for the last 23 years. He currently has a general medical practice, although he also still practices surgery. Twenty-five percent of his practice comprises Medicaid patients and 30 percent comprises Medicare patients. Respondent had about 125 AIDS patients at the time of the emergency restriction of his practice.
Respondent became interested in treating patients with pain as a result of his surgical practice. Approximately twenty-five percent of his practice is devoted to pain management.
Respondent's pain practice grew as a result of a few patients from Broward County in 1996 who recommended other "pain patients" to Respondent. Respondent admits that because of his “compassion for his patients” he was probably more indulgent than he should have been with his pain patients.
Respondent acknowledges that his medical record documentation was poor. He concedes that he relied too much on his memory and had a tendency to write down only special
negatives or positives in his findings. Respondent also often omitted information in his medical records that he thought might be stigmatizing or embarrassing to the patient. He tried to rely on his memory regarding such matters.
Respondent often has been reluctant to refer his patients to consultants because of their economic constraints. Applicable rules
The Board of Medicine has adopted rules that contain standards for the use of controlled substances for the treatment of pain. Those standards include Florida Administrative Code Rule 64B8-9.013(3), which read as follows at all times material to these consolidated cases:
Guidelines. The Board has adopted the following guidelines when evaluating the use of controlled substances for pain control:
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 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:
Urine/serum medication levels screening when requested;
Number and frequency of all prescription refills; and
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 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, documentation, and 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 be limited to:
The medical history and physical examination;
Diagnostic, therapeutic, and laboratory results;
Evaluations and consultations;
Treatment objectives;
Discussion of risks and benefits;
Treatments;
Medications (including date, type, dosage, and quantity prescribed);
Instructions and agreements; and
Periodic reviews.
Records must remain current and be maintained in an accessible manner and readily available for review.
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.
Florida Administrative Code Rule 64B8-9.003, on the subject of the adequacy of medical records, read, in pertinent part, as follows at all times material to these consolidated cases:
Medical records are maintained for the following purposes:
To serve as a basis for planning patient care and for continuity in the evaluation of the patient’s condition and treatment.
To furnish documentary evidence of the course of the patient’s medical evaluation, treatment, and change in condition.
To document communication between the practitioner responsible for the patient and any other health care professional who contributes to the patient’s care.
To assist in protecting the legal interest of the patient, the hospital, and the practitioner responsible for the patient.
A licensed physician shall maintain patient medical records in a legible manner and with sufficient detail to clearly demonstrate why the course of treatment was undertaken or why an apparently indicated course of treatment was not undertaken.
The medical record shall contain sufficient information to identify the patient, support the diagnosis, justify the treatment and document the course and results of treatment accurately, by including, at a minimum, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; reports of consultations and hospitalizations; and copies of records or reports or other documentation obtained from other health care practitioners at the
request of the physician and relied upon by the physician in determining the appropriate treatment of the patient.
All entries made into the medical records shall be accurately dated and timed. Late entries are permitted, but must be clearly and accurately noted as late entries and dated and timed accurately when they are entered into the record. However, office records do not need to be timed, just dated.
Relevant Drugs
Methadone is a legend drug and is a Schedule II controlled substance listed in Chapter 893, Florida Statutes.1 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.
Xanax is a legend drug and it 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.
Oxycontin is a legend drug and it 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 which may lead to severe physical and psychological dependence.
Dilaudid is a legend drug and it 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. Abuse of hydromorphone may lead to severe physical and psychological dependence.
Soma (Carisoprodol) is a legend drug and it is a muscle relaxant used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The effects of Carisoprodol and other drugs that depress the CNS may be additive, and Soma should be prescribed with caution to patients taking other CNS depressant medications, such as narcotics, benzodiazepine anxiolytics and tranquilizers, and barbiturates.
Fiorinal with Codeine is a legend drug and it contains Codeine and Butalbital, both Schedule III controlled substances listed in Chapter 893, Florida Statutes. Codeine is a narcotic
analgesic indicated for the relief of moderate to severe pain, and carries a significant potential for abuse and dependence. Butalbital is a barbiturate sedative which also carries a significant potential for abuse and dependence. Fiorinal with Codeine is indicated for the treatment of tension headaches.
Keflex (Cephalexin) is a semi-synthetic cephalosporin antibiotic intended for oral administration.
MS Contin is a legend drug and it contains Morphine Sulfate USP, a Schedule II controlled substance listed in Chapter 893, Florida Statutes, which is indicated for the relief of moderate to severe pain. Morphine has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States. Abuse of Morphine may lead to severe psychological or physical dependence.
Restoril contains Temazepam, a schedule IV controlled substance indicated for the relief of insomnia. The abuse of Temazepam can lead to physical or psychological dependence.
Vicodin is a legend drug and it contains Hydrocodone Bitartrate, a Schedule III controlled substance listed in Chapter 893, Florida Statutes. Hydrocodone is a narcotic analgesic indicated for the relief of moderate to severe pain, and is also used as an antitussive (cough suppressant). Hydrocodone carries a high potential for abuse and dependence.
General facts about Respondent's medical records
Respondent's medical records for each of the patients whose treatment forms the basis for the administrative complaints in these consolidated cases included an office cover sheet with a patient name. However, the individual records following the cover sheet contained no patient names. The patient's name should be on each page of medical records for that patient.
Physicians are taught in medical school to use a variation of the S.O.A.P. method for creating medical records.
S.O.A.P. is an acronym standing for Subjective, Objective, Assessment, and Plan. The basic elements of the S.O.A.P. method should be present in the records of each patient visit. In the medical records prepared by Respondent during the course of his treatment of the six patients at issue in these consolidated cases, more often than not some elements of the S.O.A.P. method were omitted. Many of Respondent's entries in these records are insufficient because they omit information required by the
S.O.A.P. method.
Admitted Facts regarding Patient S.T. (Case No. 2002-26343)
On or about December 5, 2000, Patient S.T., a 46-year- old female, first presented to Respondent with complaints of back and neck pain, bronchitis, chronic hepatitis B, bipolar illness, lupus discoid and seizure disorder. According to
Patient S.T.’s medical records, Patient S.T. had a history of being treated with controlled substances, including Dilaudid.
Based on his impression that Patient S.T. was suffering from severe asthmatic bronchitis, seizures, and lupus and needed immediate care, Respondent directed Patient S.T. to the local emergency room, where she remained in the hospital until December 9, 2000. Various tests were performed on Patient
S.T. including a complete blood count (CBC) and an electrocardiogram (EKG).
On or about December 11, 2000, Patient S.T. presented to Respondent and Respondent prescribed Albuterol and a Nebulizer for her bronchitis.
On or about January 15, 2001, Patient S.T. returned to Respondent’s’ office. During the course of that visit, Respondent prescribed the following drugs to Patient S.T.:
90 Dilaudid, 4 mg
60 Xanax, 2 mg
180 Fiorinal #3
On or about February 13, 2001, Respondent saw Patient
S.T. Patient S.T.’s records, for the February 13, 2001 visit, do not indicate the reason for the Keflex. During the course of that visit, Respondent prescribed Soma and Fiorinal #3 to Patient S.T. without documenting the presence of one or more recognized medical indications for the use of controlled
substances, and without documenting a treatment plan for Patient S.T.
On or about February 26, 2001, Patient S.T. presented to Respondent.
On or about March 13, 2001, Patient S.T. visited Respondent and complained of urinary incontinence and heartburn. During the course of that visit, Respondent prescribed the following drugs to Patient S.T.:
90 Soma, 350 mg Dilantin Fiorinal #3
90 Dilaudid, 4 mg
On or about April 12, 2001, Respondent prescribed the following drugs to Patient S.T.:
90 Soma, 350 mg
60 Xanax, 2 mg
120 Fiorinal #3
120 Methadone, 10 mg
On or about April 12, 2001, Respondent initially prescribed 90 Dilaudid, 4 mg, but then crossed this prescription out and substituted Methadone instead.
On or about May 10, 2001, Patient S.T. returned to Respondent’ office. During the course of that visit Respondent prescribed the following drugs to Patient S.T.:
60 Soma, 350 mg
60 Xanax, 2 mg
100 Firoinal #3
120 Methadone, 10 mg
On or about May 10, 2001, Respondent also prescribed Cipro and Prednisone, 10 mg, for an apparent skin condition affecting Patient S.T.’s legs.
On or about June 7, 2001, Respondent saw Patient S.T. again. During this visit, Respondent noted that Patient S.T. suffered from edema (excess fluid in cells and tissues). Respondent failed to document any other physical examination of Patient S.T. during the course of the June 7, 2001, visit. On or about June 7, 2001, Respondent treated Patient S.T.’s edema.
On or about June 7, 2001, Respondent failed to document any explanation or adequate medical justification for prescribing 60 Xanax, 2 mg, 100 Fiorinal #3 and 120 Methadone,
10 mg to Patient S.T.
On or about July 6, 2001, Patient S.T. returned to Respondent at which time he prescribed the following drugs to Patient S.T.:
60 Xanax, 2 mg
100 | Firoinal #3 | |
150 | Dilantin, 100 | mg |
120 | Methadone, 10 | mg |
On or about August 3, 2001, Patient S.T. returned to Respondent. Respondent's medical records regarding S.T.'s August 3, 2001, visit do not reflect that there was a discussion of risks and benefits of using controlled substances. During the course of that visit, Respondent prescribed the following drugs to Patient S.T.:
60 Xanax, 2 mg
100 | Fiorinal #3 |
180 | Dilantin, 100 mg |
120 | Methadone 10 mg |
On or about September 12, 2001, Respondent prescribed the following drugs to Patient S.T.:
60 Xanax, 2 mg
100 Fiorinal #3
120 Methadone 10 mg
On or about September 17, 2001, Patient S.T. presented to Respondent for a final time. During the September 17, 2001, visit, Patient S.T. complained of cellulitis (inflammation of tissue) to her abdomen. During the September 17, 2001 visit, Respondent treated Patient S.T.’s cellulitis with ointment and Tequin (an antibacterial agent).
Additional Facts regarding Patient S.T. (Case No. 2002-26343)
During her hospitalization, Patient S.T.'s treatment included Atrovent with Ventolin. Patient S.T. remained in the hospital until December 9, 2000, when she was discharged with directions to follow up with Respondent.
Contained within the medical file for Respondent are copies of magnetic resonance imaging (MRIs) for the lumbar spine (dated January 17, 2000), the brain (dated January 12, 2000) and the neck (dated January 17, 2000). The MRI of the brain was normal but the MRIs of the neck and low back showed disc herniations, among other changes. An echocardiogram was also performed on January 12, 2000 that stated “if a significant valvular lesion is still being considered, correlation with a cardiac Doppler examination is recommended.”
There is no medical record concerning Patient S.T.'s visit to Respondent's office on December 11, 2000. There is only a copy of the prescription written that day with some notes written on the bottom of the prescription.
Respondent's record for the January 15, 2001, visit with Patient S.T. consists basically of a list of prescription drugs. There is no documented subjective complaint, objective result, assessment, or treatment plan. There are also no notes concerning the treatment in the hospital or concerning the test results from January 2000.
On January 15, 2001, Respondent prescribed 90 Dilaudid
4 mg, 60 Xanax 2 mg, 180 Fiorinal #3, Dilantin, Soma and Phenergen to Patient S.T. Respondent failed to document why any of these medications were prescribed.
On February 13, 2001, Patient S.T. presented to Respondent. Respondent noted that the patient was getting Keflex (an antibiotic) on her own. Respondent’s records do not indicate any inquiry concerning how she was obtaining Keflex on her own or the reason for the Keflex.
On the February 13, 2001 visit, Respondent noted pharynx infected and no evidence of thrush. Respondent then prescribed Soma 350 (now three times per day), Cipro 500, an inhaler and Fiorinal #3 to Patient S.T. Presumably, the Cipro (an antibiotic) was prescribed for some infection, but there are no notes indicating this.
On February 13, 2001, Respondent prescribed Soma, Cipro, and Fiorinal #3 to Patient S.T. without documenting an assessment or treatment plan for Patient S.T. Respondent prescribed Soma and Fiorinal #3 to Patient S.T. without documenting the presence of one or more recognized medical indications for the use of controlled substances. Respondent does not indicate why he increased the Soma.
On February 13, 2001, Respondent noted that he wrote a prescription for Neurontin 400 but then put a note over that
that says “hold.” There is no explanation in the record for this change in treatment nor is there a reason why the Neurontin was prescribed initially.
On February 26, 2001, Patient S.T. presented to Respondent. Respondent noted that Patient S.T.’s Dilantin level was low, noted a recent seizure, and noted that there were extreme sores with two arrows pointing downward. Respondent then switched the patient to Tequinn (another antibiotic) without any explanation for the switch. There were no other subjective or objective complaints listed. Respondent failed to record an assessment or treatment plan other than to “do Dilantin level.” Respondent failed to document any medical reasons for doing a Dilantin level check if Respondent already knew the Dilantin level was low.
On March 13, 2001, Respondent prescribed #90 Soma 350 mg, Dilantin, Paxil, Xanax 2.0 mg, 90 Dilaudid 4 mg,
Fiorinal #3, Phenergen, a Nebulizer and Neurontin to
Patient S.T. There are no explanations for the prescribing of these drugs. There is no assessment, other than of the skin condition, and no written plan concerning the prescriptions given.
On March 13, 2001, Respondent also prescribed a trial of Lithium 450. There were no subjective or objective complaints concerning the reason Respondent prescribed this
drug. There is no assessment or plan concerning the prescription of this drug. Lithium can be prescribed for psychiatric diagnoses but there are no notes indicating why Respondent is prescribing this drug.
On April 12, 2001, Patient S.T. returned to Respondent. Respondent noted in Patient S.T.’s records that the DEA (Drug Enforcement Agency) “confiscated some of her meds” which were in a friend’s house. Respondent did not note any follow-up, plan, or inquiry concerning the note that the DEA confiscated Patient S.T.’s medications. Respondent noted that Patient S.T. should try to take the Lithium and that she needed a right ankle brace. There are no subjective or objective complaints in this note. There is also no assessment or plan, other than to try to take Lithium. The medical records for the visit on April 12, 2001, do not contain any explanation as to why Respondent prescribed any of the controlled substances he prescribed during that visit.
It is clearly a “red flag” when a patient informs a doctor that the DEA has confiscated her medications. When this type of event occurs, it is inappropriate and egregious for the physician to prescribe controlled substances like the ones Respondent prescribed on April 12, 2001, without inquiry and investigation into the circumstances.
On May 10, 2001, Patient S.T. returned to Respondent’s office. Respondent noted that Patient S.T. was non-diabetic. Respondent then prescribed Cipro and Prednisone 10 mg for the sores on the lower limbs. There is no explanation why Respondent switched the patient back to Cipro. There are no documented subjective or objective complaints concerning the legs other than that there were sores. There was no adequate assessment of the legs. The rest of Respondent’s medical record for May 10, 2001, is basically a list of prescriptions. There is no written explanation for the prescriptions, no assessment, and no plan concerning their use.
On July 6, 2001, Patient S.T. returned to Respondent.
Respondent listed Patient S.T.’s conditions on the side of his record. These conditions were: lupus, hepatitis, bronchitis, herpes simplex, proven non-diabetic, edema and seizure disorder. Respondent notes a plan to do a complete blood count (CBC) and Dilantin level. The rest of the record is a list of prescriptions.
During the visit on July 6, 2001, Respondent prescribed controlled substances without documenting any medical complaints by the patient. There are no subjective or objective complaints. There is no assessment or plan concerning the drugs prescribed. Respondent prescribed controlled substances to
Patient S.T. without documenting that he discussed the patient’s chronic pain with her (if she had any).
Respondent's medical records for Patient S.T.'s visit on August 3, 2001, do not contain any subjective or objective complaints. Also there is no assessment or plan concerning the drugs prescribed that day.
On September 12, 2001, Patient S.T. returned to Respondent. Respondent wrote in Patient S.T.’s record abbreviations for Glucosamine and Chondroitin. There is no other note other than a weight recorded for this visit. However, contained within Respondent’s medical file are copies of some of his prescriptions. These copies indicate that Respondent prescribed 60 Xanax 2 mg, 100 Fiorinal #3, Methadone
10 mg on this visit. On the prescription form itself, Respondent indicated that the Fiorinal was for headaches and the Methadone for pain. There are no notes at all in the medical record about these prescriptions or why they were prescribed. Further, Respondent’s medical records for September 12, 2001, fail to indicate why the Xanax was prescribed. The medical records do not contain any subjective or objective complaints. There is no assessment or plan.
It is not sufficient to write instructions and the rationale for prescribing a drug on the prescription form only. A physician should document in the medical record the
prescription, the dosing, and the reason why the drug is being prescribed. Respondent failed to do this on September 12, 2001.
On September 20, 2001, Patient S.T. died. An autopsy was performed and the cause of death was determined to be acute polydrug toxicity (Fentanyl, Codeine, Methadone, Oxycodone, Butalbital, and Alprazolam or Xanax). Butalbital is a component of Fiorinal.
The Miami-Dade County medical examiner’s report indicated that Patient S.T. had a history of drug abuse since aged 20. The toxicology report indicated that Patient S.T. had fatal doses of Fentanyl, Oxycodone and Codeine in her system.
Respondent violated the statutory standard of care2 by failing to adequately address the etiology of Patient S.T.’s pain, by prescribing controlled substances without adequate medical justification, and by failing to set up a treatment plan concerning the prescribing of controlled substances. Respondent’s actions were particularly egregious following the DEA seizure of the patient’s medication.
Respondent also violated the statutory standard of care by failing to follow the guidelines in Florida Administrative Code Rule 64B8-9.013(3) for the use of controlled substances for pain control.3
Respondent failed to keep adequate medical records justifying the course of treatment by failing to document an
appropriate plan concerning the controlled substances and by failing to document the justification for the controlled substances he prescribed. Respondent failed to keep adequate medical records documenting the source of any alleged pain and failed to document adequate progress notes.
Respondent inappropriately prescribed controlled substances to Patient S.T. Respondent inappropriately increased the Soma without noting any reason or discussion concerning this increase. Respondent also inappropriately prescribed medications by discontinuing the Dilaudid and prescribing the Methadone without justification or explanation. Finally, Respondent inappropriately prescribed controlled substances to Patient S.T. after learning that the DEA had seized her medications.4
Admitted Facts regarding Patient C.C. (Case No. 2002-26342)
On or about August 2, 2001, Patient C.C., a 45-year- old male, first presented to Respondent with a history of several injuries including a left and right hip replacement, a left ankle fusion, and a right ankle compound break. According to Patient C.C.’s medical records for this visit, Respondent verified the injuries reported by Patient C.C. by only examining the surgical scars on Patient C.C.’s body. At the conclusion of this visit, Respondent instructed Patient C.C. to return with copies of his X-rays and to undergo “blood work”. During the
course of this visit, Respondent prescribed 90 Dilaudid, 4 mg, and 60 Oxycontin, 80 mg, to Patient C.C.
On or about August 6, 2001, Respondent prescribed 15 Xanax, 2 mg, to Patient C.C. Patient C.C.’s medical records for the August 6, 2001, visit do not contain examination results or subjective or objective complaints.
On or about August 23, 2001, Patient C.C. returned to Respondent’s office, whereupon, Respondent prescribed 90 Dilaudid, 4 mg, and 30 MS Contin, 100 mg, to Patient C.C. Patient C.C.’s records for the August 23, 2001, visit reflect that the only physical examination results recorded are weight and blood pressure. Patient C.C.’s records for the August 23, 2001, visit reflect that Patient C.C. did not provide Respondent with copies of his X-rays. Patient C.C.’s records for the August 23, 2001, visit also reflect that Patient C.C. did not provide Respondent with verification of completion of the “blood work” that Respondent requested during Patient C.C.’s visit of August 2, 2001.
On or about September 19, 2001, Patient C.C. returned to Respondent’s office complaining of an upper respiratory infection. Respondent renewed Patient C.C.’s prescriptions for
90 Dilaudid, 4 mg, and 30 MS Contin, 100 mg.
On or about September 20, 2001, Respondent prescribed
30 Xanax, 2 mg, to Patient C.C. by telephonic order.
On September 26, 2001, Patient C.C. presented to Respondent. Patient C.C.’s medical records for the
September 26, 2001, visit indicate that Patient C.C. complained of a gastrointestinal disorder. Patient C.C.’s medical records for the September 26, 2001 visit indicate that Respondent again noted: “must do lab work.”
Patient C.C.’s medical records contain what appears to be an entry for September 29, 2001, which simply states “Restoril 30 — trial.”
On or about October 11, 2001, Respondent prescribed 30 Vicodin ES by telephonic order for Patient C.C.
Patient C.C.’s final visit to Respondent occurred on or about October 19, 2001. During the course of that visit, Patient C.C. complained of a contusion that resulted from a fall. Patient C.C.’s medical records for the October 19, 2001, visit fail to document which part of Patient C.C.’s body was contused. Patient C.C.’s records for the October 19, 2001, visit do not contain any documentation that Respondent performed a physical examination of Patient C.C. During the course of the October 19, 2001, visit, Respondent prescribed the following drugs to Patient C.C.:
90 Dilaudid, 4 mg
90 Soma, 350 mg
60 MS Contin, 100 mg
Additional Facts regarding Patient C.C. (Case No. 2002-26342)
In the medical record of the August 2, 2001, visit there are no notations as to when the injuries occurred or which injury was causing a complaint that day, if any. Respondent noted that the patient was disabled and on Medicare. On
August 2, 2001, in addition to the Dilaudid and Oxycontin, Respondent also prescribed Fiorinal with Codeine and Tuinal (a short-acting barbiturate).
Respondent’s medical records for Patient C.C.’s August 2, 2001, visit do not contain examination results or subjective or objective complaints. The record has no assessment of Patient C.C.’s hips or ankles. Respondent requested copies of the X-rays from the patient, presumably to confirm the prior injuries to the hips and ankles. There is no indication in the record that Respondent ever tried to obtain the X-rays himself.
In the medical record for the August 23, 2001, visit, Respondent did not document any indication why he switched Patient C.C. from Oxycontin to MS Contin. The Dilaudid was prescribed apparently for “breakthrough pain.” However, there
are no notes concerning the severity of any pain or the source of any pain. Respondent also noted on this visit that the patient had GERD (gastroesophogeal reflux disease) or irritable bowel syndrome. No subjective complaints or symptoms are recorded. He questioned whether it was due to diet and thought he might be a candidate for Librax (a medication used for irritable bowel disease). Respondent then gave Patient C.C. a sample of Prevacid (a medication that can treat GERD).
In the medical record for the September 19, 2001, visit there are no notations concerning the patient's respiration or whether he was wheezing. No other symptoms are recorded. Respondent did not record any objective results, failed to record any assessment and did not record an adequate plan. Respondent gave the patient a Zithromax sample for the respiratory infection. Respondent then renewed Patient C.C.’s prescriptions for #90 Dilaudid 4 mg and #30 MS Contin 100 mg. There are no records indicating why these medications were prescribed.
The medical record for Patient C.C. does not document why Respondent prescribed Xanax to the patient by telephone on September 20, 2001.
The medical records for the October 11, 2001, visit contains no notations as to why Respondent prescribed Vicodin ES, nor are there any subjective or objective complaints noted.
In the medical record for the October 19, 2001, visit, there is no chief complaint recorded, other than the contusion. There is no assessment and no plan other than prescribing narcotics. There are no indications in the record as to why prescriptions for Dilaudid, Soma, and MS Contin were written, or what chief complaint required these medications.
On October 29, 2001, Patient C.C. died. The medical examiner’s report stated that the cause of death was acute morphine toxicity. The toxicology report indicated the following drugs were detected in Patient C.C.’s body: Alprazolam or Xanax, Benzodiazepines, Meprobamate, Corisoprodol or Soma and Morphine. The medical examiner's report also detailed a history of a motor vehicle accident at aged 17 (approximately 28 years before Respondent first saw the patient). The medical history indicated that Patient C.C. broke his legs during this accident and that the legs never healed properly.
The medical examiner’s report also indicated a social history of drug abuse, both illegal and prescription, as well as prior suicidal attempts years ago by cutting his wrists. There were also the typical track or needle marks on the arms that would have been visible a month or longer before death.
Respondent did not record the detailed medical history from the motor vehicle accident nor the past suicide attempts. Even if the patient was not candid with Respondent, an
examination of Patient C.C.’s arms would have revealed the prior track or needle marks as well as the prior marks from the suicide attempts. However, Respondent’s records do not contain any such details.
Respondent failed to practice medicine within the statutory standard of care by failing to adequately assess Patient C.C.’s pain, failing to create an adequate treatment plan and by failing to obtain prior medical records to review past drug use. Respondent also violated the statutory standard of care by inappropriately prescribing controlled substances without adequate medical justification and by refilling controlled substances without identifying a chief complaint, without performing a review of systems, without performing adequate physical exams and assessments, and without preparing adequate plans.
Respondent also failed to meet the statutory standard of care by failing to follow the guidelines in Florida Administrative Code Rule 64B8-9.013(3) for the use of controlled substances for pain control.
Respondent failed to keep adequate medical records that justify the course of treatment by failing to document a complete medical history as well as a history of Patient C.C.’s present complaint, and by failing to document adequate physical exams, adequate treatment plans and assessments of the etiology
of Patient C.C.’s pain. Respondent also failed to keep medical records that justify the course of treatment by failing to document a discussion of risks and benefits of using controlled substances, and the medical justification for the continued treatment with controlled substances.
Respondent inappropriately prescribed controlled substances to Patient C.C. Respondent continued to inappropriately prescribe controlled substances to this patient without a definitive diagnosis and without verifying the patient’s medical history and past drug use.
Admitted Facts regarding Patient B.F. (Case No. 2002-26340)
On or about October 15, 2001, Patient B.F., a 55-year- old female, presented to Respondent with complaints of lower back pain, polyneuropathy, bronchitis, a history of HIV (human immunodeficiency virus), AIDS (acquired immunodeficiency syndrome), heroin addiction, and hepatitis C. No other physical exam results are documented. During the course of this visit, Respondent prescribed the following drugs to Patient B.F.:
90 Oxycontin, 80 mg
60 Xanax, 2 mg
On or about November 15, 2001, Patient B.F. returned to Respondent’s office. Patient B.F.’s medical records for the November 15, 2001, visit do not document that Respondent performed a review of systems. Patient B.F.’s medical records
for the November 15, 2001, visit do not document that Respondent performed an adequate physical examination of Patient B.F. during this visit. Respondent then noted that “Pt to bring in all her HIV meds for renewal.” During the course of the November 15, 2001, visit, Respondent prescribed the following drugs to Patient B.F.:
90 Oxycontin, 80 mg
60 Xanax, 2 mg
There is no documentation in Patient B.F.’s medical record for the December 17, 2001, visit that Respondent received the prior HIV medical records. There is no documentation in Patient B.F.’s medical record for the December 17, 2001, visit that Respondent addressed the nature or intensity of Patient B.F.’s pain.
On or about January 14, 2002, Patient B.F. returned to Respondent with complaints of severe asthmatic bronchitis. Patient B.F.’s records for the January 14, 2002, visit reflect that Respondent treated Patient B.F.’s bronchitis with medication. Patient B.F.’s records for the January 14, 2002, visit reflect that Respondent renewed Patient B.F.’s prescription for 90 Oxycontin, 80 mg, and for 60 Xanax, 2 mg.
Patient B.F.’s medical records of February 12, 2002, indicate that Respondent needs lab work at the next visit.
On or about March 15, 2002, Patient B.F. returned to Respondent’s office. Patient B.F.’s medical records for the March 15, 2002, visit reflect that Patient B.F.’s pain was fluctuating and that her anxiety was high. On the March 15, 2002, visit Respondent briefly listened to Patient B.F.’s lungs and noted her blood pressure and pulse. On the March 15, 2002, visit, Respondent renewed Patient B.F.’s prescriptions for 90 Oxycontin, 80 mg, and for 60 Xanax, 2 mg.
Additional Facts regarding Patient B.F. (Case No. 2002-26340)
During the visit on October 15, 2001, Respondent documented a painful lumbar region. However, Respondent did not document results of other physical exams, including the level of pain for the lower back, the location of the polyneuropathy in the body, and the rate of respiration. Lab tests were ordered. There is no clear indication from the medical records of the first visit what Respondent’s treatment plan was for this patient.
At Patient B.F.'s visit on November 15, 2001, Respondent wanted to see if the patient qualified for Neupogen. He also recommended Glucosomine and Chondroitin with water exercises. He also noted that the liver studies reflected hepatitis C.
Respondent’s recommendation to try Neupogen is unexplained. Because Neupogen stimulates white blood cells and
Patient B.F.’s white blood count was normal, there was no justification for Respondent’s consideration of Neupogen.
Respondent’s medical record for his December 17, 2001, visit with Patient B.F. is very brief. He wrote a blood pressure reading and the word “pulse” but with no reading next to it. He also drew an arrow pointing up next to the words “bronchitis; smoking !!”. There are no subjective complaints documented, no assessment, and no treatment plan documented.
During the December 17, 2001, visit, Respondent prescribed #60 Xanax 2.0 mg and #90 Oxycontin 80 mg for Patient
B.F. Respondent failed to document a reason for prescribing these two controlled substances. There is also no documented plan concerning treatment for the notation about the increased bronchitis or smoking.
Regarding the January 14, 2002, visit, there are no subjective complaints listed other than the one about severe asthmatic bronchitis. There is no documented physical exam or review of systems for this visit. The record does not contain any details of the patient’s respirations or diagnosis as to whether this was an acute bronchial attack or chronic bronchitis.
In the medical records for the January 14, 2002, visit, Respondent noted that he had a discussion about Oxycontin
with Patient B.F. However the record does not reflect why the drug was prescribed.
On February 5, 2002, Patient B.F. returned to Respondent. Respondent’s note on this date is also brief. It contains a blood pressure, a pulse and a weight. Respondent also notes “GERD - ? to meds or anx.?” and gives the patient a sample of Prevacid for this problem. GERD means gastro- esophageal reflux disease.
Respondent once again prescribed #90 Oxycontin 80 mg and #60 Xanax 2.0 mg. Respondent also prescribed some drugs for Patient B.F.’s HIV condition. However, there are no notes explaining why the Oxycontin and Xanax were prescribed. There is no assessment of the prior bronchial problems, the prior back problems, or any new complaints.
On February 12, 2002, Patient B.F. returned to Respondent’s office. Respondent’s medical record indicated that Patient B.F. needs lab work at the next visit and contained a list of prescriptions. Respondent provides no indication why the various drugs were prescribed, no assessment of the patient, no subjective complaints detailed and no plan for treating the patient.
Respondent saw Patient B.F. again on March 15, 2002.
At that time he noted decreased breath signs, and at some later time he recorded the lab results. On the March 15, 2002 visit,
Respondent also questioned the patient’s “compliance.” There was no explanation given as to what type of compliance issues were of concern to Respondent. Respondent then renewed Patient B.F.’s prescription for #90 Oxycontin 80 mg and #60 Xanax 20 mg.
On March 25, 2002, Patient B.F. died. According to the initial Miami-Dade County Medical Examiner’s report, the cause of Patient B.F.’s death was accidental heroin and Xanax intoxication. The contributing causes were AIDS and
Hepatitis C.
A toxicology report was issued on October 1, 2004, by the Miami Dade County Medical Examiner’s office. This report was positive for Oxycodone, Methadone, Morphine, Codeine, and Alprazolam or Xanax.
The Miami-Dade County Medical Examiner’s office issued an amended report on November 2, 2004, indicating that Patient B.F.’s cause of death was polydrug intoxication (Heroin, Oxycodone, Methadone, and Alprazolam or Xanax). The contributing causes were AIDS and Hepatitis C. The report added Oxycodone and Methadone as contributing to the death.
Both the original and the amended Medical Examiner reports contain a social history indicating that Patient B.F. was a known IV drug abuser and had received treatment at a local Methadone clinic.
None of Respondent’s medical records for Patient B.F. contain a past or current history of treatment at a Methadone clinic. The records also fail to identify whether Respondent inquired about any current drug abuse. Respondent should have inquired about, and should have documented, any Methadone treatment Patient B.F. was involved in before Respondent instituted his own treatment in order to prescribe narcotics properly.
This patient was a complicated case and would have benefited from a multi-disciplinary team approach.5
In his treatment of Patient B.F., Respondent failed to practice medicine within the statutory standard of care by inappropriately prescribing controlled substances without adequate medical justification and by failing to follow the guidelines in Florida Administrative Code Rule 64B8-9.013(3) for the use of controlled substances for pain control. Respondent also violated the statutory standard of care by failing to sufficiently assess the bronchial asthmatic condition by noting the patient’s respiratory rate and degree of wheezing.
Respondent failed to keep adequate medical records that justify the course of treatment by failing to document adequate physical exams, by failing to document an adequate review of systems, by failing to document a treatment plan, and
by failing to document the respiratory rate and degree of wheezing related to B.F.’s bronchial asthmatic condition.
Respondent failed to keep adequate medical records to justify the course of treatment by failing to document adequate justification for prescribing Oxycontin on the first visit and for continuing to prescribe Oxycontin and Xanax in a patient with a history of heroin abuse.
Respondent inappropriately prescribed Oxycontin to Patient B.F. on the first visit and inappropriately prescribed Oxycontin and Xanax to her on subsequent visits without adequate medical justification. Many of Respondent’s medical records are merely a list of the drugs prescribed without any rationale or reason stated for the prescriptions. Respondent inappropriately prescribed controlled substances without documenting a physical exam, a review of systems, assessments, or any plans for the patient and without inquiring about the patient's Methadone clinic treatment.
Admitted Facts regarding Patient D.P. (Case No. 2002-12858)
On or about February 2, 2002, Patient D.P., a 25-year old male, presented to Respondent’s office with complaints of severe lower lumbar pain with radiation into both thighs, left greater than right. The medical record for this visit contains a brief family history, social history, and notation of no allergies in the medical records. The medical record for this
visit has no adequate review of symptoms. Respondent documented that the patient is to furnish the X-rays of his lumbar spine, and pending this review, Respondent elected to hold off on ordering an MRI (magnetic resonance imaging). Blood work was deferred to the next visit. Further instructions included glucosamine and chondroitin and water exercises. During the course of the February 2, 2002, visit, Respondent prescribed the following drugs to Patient D.P.:
240 Methadone, 10 mg
120 Dilaudid, 4 mg
90 Xanax, 2 mg
On or about March 1, 2002, Patient D.P. returned to Respondent with a complaint of an area of baldness in the upper right occipital area, secondary to striking his head. Patient
D.P. also had complaints concerning his left great toe.
Respondent again requested that Patient D.P. supply him with his lumbar X-rays. During the course of this visit, Respondent prescribed the following drugs to Patient D.P.:
60 Soma, 350 mg
90 Xanax, 2 mg
120 Dilaudid, 4 mg
Respondent’s medical records indicate that on or about March 30, 2002, a Saturday, Patient D.P. appeared for an office visit. The medical records indicate that some type of
final warning was given. The record indicates that on or about March 30, 2002, Respondent prescribed the following drugs to Patient D.P.:
60 Soma, 350 mg
90 Xanax, 2 mg
105 Dilaudid, 4 mg
On the record of the March 30, 2002, visit, after the Dilaudid, Respondent wrote, “start to lower.” There is also an entry that Patient D.P. paid $75.00 for this visit.
Respondent did not see Patient D.P. on the March 30, 2002, visit because the patient was late. Respondent sent Petitioner a letter on or about August 29, 2002, indicating that Respondent did not see Patient D.P. on the March 30, 2002, visit because the patient was late. Respondent’s secretary waited for the patient in order to give him the prescriptions written by Respondent.
Additional Facts regarding Patient D.P. (Case No. 2002-12858)
Patient D.P. presented to Respondent with a history of prescriptions for Methadone, Dilaudid, Xanax, and Oxycontin. Although Respondent wrote refill prescriptions for Methadone, Dilaudid, and Xanax, he did not write a refill prescription for Oxycontin. There is no explanation in the medical record for the Respondent's decision not to refill the Oxycontin.
Respondent failed to document an explanation for continuing some of the pain medications and discontinuing the Oxycontin. It is not safe to discontinue Oxycontin abruptly. Respondent also failed to document the name of the physician who previously prescribed the above-described pain medications and failed to document any need to obtain the medical records from the prior physician.
Patient D.P. presented to Respondent with several “red flags.” Among the “red flags” were: a young man with a list of previously used pain medications, no X-rays, and a request to refill the pain medications based on unverified back pain.
The medical record for Patient D.P.'s visit on March 1, 2002, does not indicate what medical conditions the
pain medications that were prescribed on that date were supposed to treat. Two body parts (the head and large toe) were identified with subjective complaints. An appropriate objective note was not made. The medications prescribed on March 1, 2002, were essentially the same as those prescribed during the February 2, 2002, visit but with no mention of back problems in the record of the March 1, 2002 visit.
In a patient such as D.P., pain is a vital sign and should be documented. Pain is usually documented on a scale of
one to ten. There is no record of pain for any of the three body parts (head, back or great toe).
Soma was also prescribed on this visit. There is no documented justification for the prescription of Soma.
On April 1, 2002, Patient D.P. died of a combined drug overdose (Methadone, Xanax, Alprazolam, Soma, Carisoprodol, and Meprobamate). A toxicology exam was done, with a follow-up confirming report. The report was positive for Xanax, Soma, Methadone, and the metabolites for Cocaine. The report showed fatal or lethal levels of Methadone and Xanax in Patient D.P.’s body.
Respondent violated the statutory standard of care by prescribing controlled substances to Patient D.P. without even seeing or examining him. Respondent also violated the statutory standard of care by prescribing the controlled substances inappropriately without adequate justification. Respondent also violated the statutory standard of care by his inadequate physical exams, especially on the visits after February 2, 2002.
Respondent’s medical records for this patient fail to justify the course of treatment for all of the visits. There is an inadequate history of any prior back problem or drug abuse problem. The records concerning any physical exam are inadequate. Respondent’s records for this patient fail to contain an adequate history documenting any prior diagnostic
testing or diagnosis that would have been the basis for his previously prescribed drugs.
The medical record of March 30, 2002, fails to accurately describe what actually happened that day. Further, the medical record for that date is written in such a way as to suggest that Respondent had seen and treated the patient on that date, when, in fact, Respondent did not see Patient D.P. on March 30, 2002.
Respondent inappropriately prescribed Soma, Methadone, Xanax, and Dilaudid to Patient D.P. In addition, he inappropriately prescribed the Soma, Xanax, Methadone and Dilaudid when he left them with his secretary for Patient D.P. to pick up without examining Patient D.P. or discerning a need for these drugs. Respondent left the prescriptions "out of compassion" for D.P. In hindsight, Respondent admits that it was a mistake to do so. He had never done such before and has not done it since.
During the course of his treatment of Patient D.P., Respondent failed to follow the guidelines in Florida Administrative Code Rule 64B8-9.013(3) for the use of controlled substances for pain control.
Admitted Facts regarding Patient F.K. (Case No. 2002-26339)
On or 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. According to Patient F.K.’s medical records, Patient F.K., had a history of heroin addiction in the past. According to Patient F.K.’s medical records, Patient F.K. has a documented history of hepatitis 30 years ago, most likely from a needle. According to Patient F.K.’s medical records, Patient F.K.’s current medications included Methadone, 80 mg/day, Oxycontin, 80 mg qid (4 times daily), and Xanax, 2.0 mg, “3, 4, or 5”. On or about January 31, 2002, Respondent ordered lab work for Patient F.K. On or about January 31, 2002, Respondent noted in Patient F.K.’s medical records that the X-ray reports were “on the way.” On or about January 31, 2002, Respondent also recommended Glucosamine and Chondroitin for Patient F.K., both to be taken twice daily.
During the course of the visit on January 31, 2002, Respondent prescribed the following drugs to Patient F.K.:
120 Xanax, qid
240 Methadone (8 pills/day)
180 Dilaudid (6 per day)
On or about March 4, 2002, Patient F.K. returned to Respondent’s office. On or about March 4, 2002, Respondent noted that Patient F.K. was stabilizing. On or about March 4, 2002, Respondent noted that Patient F.K.’s X-ray reports were pending at the prison. On or about March 4, 2002, Respondent
did not record an adequate examination or a range of system review for Patient F.K. On or about March 4, 2002, the lab data was reviewed and a notation that Patient F.K. was a non-diabetic was made. On or about March 4, 2002, Respondent recommended water exercises and Glucosamine/Chondroitin for Patient F.K. On or about March 4, 2002, Respondent failed to document in Patient F.K.’s medical record that he had performed a physical examination. On or about March 4, 2002, there is an entry in Patient F.K.’s medical record that states the pain is a combination of pathology and depression. On or about March 4, 2002, the Respondent failed to document in Patient F.K.’s medical records that he discussed the risks and benefits of the use of controlled substances with Patient F.K.
During the course of the visit on March 4, 2002, Respondent prescribed the following drugs to Patient F.K.:
180 Dilaudid, 4 mg
240 Methadone
120 Xanax, 2 mg
On or about April 1, 2002, it was noted that Patient
F.K. was doing water exercises. On or about April 1, 2002, Respondent failed to document in his medical records a physical examination or review of Patient F.K.’s systems. During the course of the April 1, 2002 visit, Respondent prescribed the following drugs to Patient F.K.:
90 Xanax, 2 mg
240 Methadone, 10 mg, 2 q6h (every six hours)
180 Dilaudid, $ mg, 2 q8h (every eight hours)
On or about April 1, 2002, there is also an entry in Patient F.K.’s medical records that a pharmacist called to discuss and confirm the medications prescribed.
On or about April 29, 2002, Patient F.K. presented to Respondent’s office. On or about April 29, 2002, an entry in Patient F.K.’s medical record indicates that the patient will try to get his X-ray report that was done while in prison, apparently in early 2000. On or about April 29, 2002, Respondent did not document in Patient F.K.’s medical record that he 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. During the course of the April 29, 2002, visit, Respondent prescribed the following drugs to Patient F.K.:
90 Xanax, 2 mg
240 Methadone, 10 mg
180 Dilaudid, 4 mg
On or about May 25, 2002 (a Saturday), Patient F.K. returned to Respondent’s office. On or about May 25, 2002, Respondent noted that the patient was recently incarcerated and could not persist in his efforts to get the X-rays from prison.
On or about May 25, 2002, there is no documented physical examination or review of systems in Patient F.K.’s medical records. On or about May 25, 2002, Respondent recommended that Patient F.K. continue water exercises with Glucosomine and Chrondroiton.
During the course of the visit on May 25, 2002, Respondent prescribed the following drugs to Patient F.K.:
90 Xanax, 2 mg
240 Methadone, 10 mg
180 Dilaudid, 4 mg
On or about May 25, 2002, Respondent ordered X-rays for Patient F.K.’s right knee and back ASAP.
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).
Additional Facts regarding Patient F.K. (Case No. 2002-26339)
In his medical records for the visit on January 31, 2002, Respondent indicates “severe low back syndrome,” but does not indicate how he reached this diagnosis.
On April 1, 2002, Patient F.K. presented to Respondent’s office for polyarthritis. There is no other note concerning the polyarthritis such as its location, duration or severity. On April 1, 2002, Respondent also failed to document
an assessment of any problems or a treatment plan, other than prescribing Xanax, Methadone, and Dilaudid.
A telephone call from a pharmacist about prescriptions for narcotic drugs is often perceived as a “red flag.” This phone call, combined with the patient’s heroin history, should have alerted Respondent that Patient F.K. was a drug seeker or drug user with a history of abuse.
Respondent's records for the April 29, 2002, visit do not indicate why Respondent prescribed Xanax, Methadone, and Dilaudid to Patient F.K.
Patient F.K.’s history of incarceration is another “red flag” which should have been taken into account before prescribing controlled substances to this patient.
Respondent's records for the May 25, 2002, visit do not indicate why Respondent prescribed Xanax, Methadone, and Dilaudid to Patient F.K.
Prior to May 25, 2002, Respondent should have himself either obtained Patient F.K.'s X-rays from the prison or he should have ordered X-rays for the back and right knee sooner and before prescribing controlled substances over an extended period of time.
At the time of his death, Patient F.K.’s level of Methadone recorded from the toxicology screen was in the toxic or lethal range. The level of Cocaine was at a low level.
Patient F.K. would have benefited from a multi- disciplinary team approach. The multi-disciplinary approach could have dealt with his addiction problems, as well as his physical ailments.6
Respondent violated the statutory standard of care by failing to perform adequate physical exams, failing to identify or recommend a treatment plan, and by failing to adequately assess any pain the patient had. Respondent also violated the statutory standard of care by prescribing controlled substances to this patient without adequate medical justification, and prescribing controlled substances for pain before ordering or obtaining X-rays.
Respondent also violated the statutory standard of care by failing to follow the guidelines in Florida Administrative Code Rule 64B8-9.013(3) for the use of controlled substances for pain control.
Respondent failed to keep adequate medical records justifying the course and scope of treatment for Patient F.K. Respondent failed to adequately document justification for the controlled medications, failed to document adequate physical examinations, and failed to document an appropriate treatment plan for this patient.
Respondent inappropriately prescribed controlled substances without adequate medical justification to Patient F.K.
Admitted Facts regarding Patient A.C. (Case No. 2002-26341)
On or about March 13, 2001, Patient A.C., a 43-year- old male, first presented to Respondent. The medical record for that visit notes that Respondent questioned a loss of Patient A.C.’s medications and that the patient is to return with X- rays.
On or about March 19, 2001, Patient A.C. returned to Respondent’s office with his X-rays. On or about March 19, 2001, Respondent noted that the X-rays were indicative of significant advanced lumbar disc disease. On or about March 19, 2001, the recorded history also noted that Patient A.C. was involved in a motor vehicle accident on February 3, 2000. On or about March 19, 2001, Respondent noted a complaint of pain in the lumbar region radiating to both of Patient A.C.’s thighs, left greater than right. On or about March 19, 2001, Respondent ordered laboratory studies for Patient A.C. Respondent’s medical record of March 19, 2001, also contains a note that a pharmacy advised Respondent that Patient A.C. was “on Oxycontin
40 mg before.” Respondent notes in Patient A.C.’s record of March 19, 2001, the names of two doctors.
On or about March 19, 2001, Respondent gave Patient
A.C. samples of HCTZ (hydrochlorothiazide), an anti- hypertensive. On or about March 19, 2001, Respondent started Patient A.C. on Tevetan, an anti-hypertensive, 600 mg daily.
During the course of the visit on March 19, 2001, Respondent also prescribed the following drugs to Patient A.C.:
60 Oxycontin, 80 mg
Xanax, 2 mg, bid (twice daily)
On or about March 21, 2001, Patient A.C. returned to Respondent’s office. On or about March 21, 2001, there are no notes in Patient A.C.’s medical records concerning a physical examination or review of systems. On or about March 21, 2001, there is also a note in Patient A.C.'s medical records about a pending evaluation with no details concerning the proposed evaluation. On or about March 21, 2001, Patient A.C.’s record also contains a note that his next appointment was April 4, 2001.
On or about March 21, 2001, Respondent’s medical records also contain a dated entry of March 19, 2001, that lists Patient A.C.’s medications on this date as HCTZ 25 mg daily; Tevetan 600 mg daily; Norvasc 5 mg, 2 daily; Xanax 2 mg bid; and Oxycontin 80 mg bid.
On or about March 21, 2001, Patient A.C.’s record does not reflect that the Respondent attempted to obtain Patient
A.C.’s past medical records in order to verify Patient A.C.’s reported injuries and medical history. On or about March 21, 2001, Respondent did not document a treatment plan for Patient
A.C. other than to order or request lab work.
On or about April 1, 2001, Patient A.C. was transported to Broward General Hospital where he was pronounced dead at 9:06 a.m. 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 that the following drugs were detected in Patient A.C.'s body: Benzoylecgonine, Cocaine, Ecgonine, Methylester, and Oxycodone. Additional Facts regarding Patient A.C. (Case No. 2002-26341)
Respondent also noted in the medical record for March 19, 2001, two doctors’ names (“Roonig” and”Washman”). Next to these names Respondent noted “ pt. given Oxycontin 160 #116 on 3/14” and under that “Oxycontin 40 + 20 Sig T.I.D. on 2/17.” There is no indication in the medical record that Respondent attempted to contact either of the doctors mentioned in his note or to obtain any of the medical records from either doctor. There are no notes about counseling the patient about the consequences of taking controlled substances.
There is no indication in the medical records as to why Respondent prescribed Xanax and Oxycontin to this patient on March 19, 2001. Although the medical records for March 19,
2001, contain some subjective and objective results, there is no assessment or treatment plan for this patient. Respondent failed to document how he was managing the pain medication prescribed for this patient, particularly since the patient was obtaining Oxycontin from two other doctors.
Respondent knew or should have known that Patient
A.C. was a doctor shopper (an individual going to numerous doctors in order to obtain a number of controlled medications). Patient A.C. would have benefited from a multi-disciplinary team approach.7 Patient A.C. obviously had an addiction problem and that should have been apparent to Respondent.
Respondent violated the statutory standard of care by failing to perform adequate physical exams, by failing to identify or recommend a treatment plan, and by failing to obtain past medical records.
Respondent also violated the standard of care by prescribing controlled substances to this patient without adequate medical justification and by failing to follow the guidelines in Florida Administrative Code Rule 64B8-9.013(3) for the use of controlled substances for pain control.8
Respondent failed to keep adequate medical records justifying the course and scope of treatment for Patient A.C. Respondent failed to adequately document justification for the controlled medications, failed to document adequate physical
examinations, failed to document a complete history and failed to document an appropriate treatment plan for this patient.
Respondent also failed to keep adequate progress notes.
Respondent inappropriately prescribed controlled substances to Patient A.C. without adequate medical justification.
CONCLUSIONS OF LAW
The Division of Administrative Hearings has jurisdiction over the parties to and the subject matter of this proceeding, pursuant to Sections 120.569, and 120.57(1), Florida Statutes, and Section 456.073, Florida Statutes.
Section 458.331(1), Florida Statutes, authorizes the Board of Medicine to take disciplinary action upon proof of grounds that include the following:
(m) Failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed physician or the physician extender and supervising physician by name and professional title who is or are responsible for rendering, ordering, supervising, or billing for each diagnostic or treatment procedure and that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations.
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(q) 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 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.
* * *
(t) Gross or repeated malpractice or the failure 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. The board shall give great weight to the provisions of
s. 766.102 when enforcing this paragraph. As used in this paragraph, "repeated malpractice" includes, but is not limited to, three or more claims for medical malpractice within the previous 5-year period resulting in indemnities being paid in excess of
$50,000 each to the claimant in a judgment or settlement and which incidents involved negligent conduct by the physician. As used in this paragraph, "gross malpractice" or "the failure 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," shall not be construed so as to require more than one instance, event, or act. Nothing in this paragraph shall be construed to require that a physician be incompetent to practice medicine in order to be disciplined pursuant to this paragraph. A recommended order by an administrative law judge or a final order of
the board finding a violation under this paragraph shall specify whether the licensee was found to have committed "gross malpractice," "repeated malpractice," or "failure to practice medicine with that level of care, skill, and treatment which is recognized as being acceptable under similar conditions and circumstances," or any combination thereof, and any publication by the board must so specify.
Pursuant to Section 456.072(2), Florida Statutes, when a licensee is found guilty of one or more of the grounds set forth above, the Board of Medicine may impose one or more of the following penalties:
Refusal to certify, or to certify with restrictions, an application for a license.
Suspension or permanent revocation of a license.
Restriction of practice or license, including, but not limited to, restricting the licensee from practicing in certain settings, restricting the licensee to work only under designated conditions or in certain settings, restricting the licensee from performing or providing designated clinical and administrative services, restricting the licensee from practicing more than a designated number of hours, or any other restriction found to be necessary for the protection of the public health, safety, and welfare.
Imposition of an administrative fine not to exceed $10,000 for each count or separate offense. If the violation is for fraud or making a false or fraudulent representation, the board, or the department if there is no board, must impose a fine of $10,000 per count or offense.
Issuance of a reprimand or letter of concern.
Placement of the licensee on probation for a period of time and subject to such conditions as the board, or the department when there is no board, may specify. Those conditions may include, but are not limited to, requiring the licensee to undergo treatment, attend continuing education courses, submit to be reexamined, work under the supervision of another licensee, or satisfy any terms which are reasonably tailored to the violations found.
Corrective action.
Imposition of an administrative fine in accordance with s. 381.0261 for violations regarding patient rights.
Refund of fees billed and collected from the patient or a third party on behalf of the patient.
Requirement that the practitioner undergo remedial education.
In determining what action is appropriate, the board, or department when there is no board, must first consider what sanctions are necessary to protect the public or to compensate the patient. Only after those sanctions have been imposed may the disciplining authority consider and include in the order requirements designed to rehabilitate the practitioner. All costs associated with compliance with orders issued under this subsection are the obligation of the practitioner.
The burden of proof is on the party asserting the affirmative of an issue before an administrative tribunal, Florida Department of Transportation v. J.W.C. Company, Inc.,
396 So. 2d 778 (Fla. 1st DCA 1981). Petitioner has the burden of proof in this proceeding. To meet its burden, Petitioner must establish the facts upon which its allegations are based by clear and convincing evidence. Department of Banking and
Finance, Division of Securities and Investor Protection v. Osborne Stern Company, 670 So. 2d 932 (Fla. 1996) and Sections 120.57(1)(j) and 458.331(3), Florida Statutes.
By operation of legislation enacted during the 2003 session of the Florida Legislature, effective September 15, 2003, "[t]he determination of whether or not a licensee has violated the laws and rules regulating the profession, including a determination of the reasonable standard of care, is a conclusion of law to be determined by the board . . . and is not a finding of fact to be determined by an administrative law judge." See Chapter 2003-416, Laws of Florida, at Section 20 (amending Section 456.073(5), Florida Statutes (2002)). There does not yet appear to be any decisional guidance from any of the Florida appellate courts, as to what extent, if any, the above-quoted amendment requires any changes in the manner in which hearings before the Division of Administrative Hearings should be conducted, or requires any changes in the content of the recommended orders prepared by the DOAH administrative law judges. By their conduct at hearing both parties seemed to be of the view that the above-quoted statutory amendments did not change the nature of the evidence to be offered in cases of this nature, because both parties requested, and were granted, the opportunity to offer expert witness testimony on the subject matter of whether Respondent "has violated the laws and rules
regulating the profession," as well as on the subject matter of what constitutes the "reasonable standard of care."
The Proposed Recommended Orders submitted by the parties do not suggest that the above-quoted statutory language requires any changes to the nature of the content that has customarily been included in recommended orders in cases of this nature. Because the amendments appear to address matters of procedure rather than matters of substance, the amendments appear to be applicable to cases pending as of the effective date of the law that created the amendments.9 See Basel v.
McFarland & Sons, Inc., 815 So. 2d 687 (Fla. 5th DCA 2002), in which the court noted at page 692: "In the absence of clear legislative intent, a law affecting substantive rights is presumed to apply prospectively only while procedural or remedial statutes are presumed to operate retrospectively. See Young v. Altenhaus, 472 So. 2d 1152 (Fla. 1985)." See also Life Care Centers of America, Inc. v. Sawgrass Care Center, Inc., 683 So. 2d 609 (Fla. 1st DCA 1996).
The language of the subject amendments to Section 456.073(5), Florida Statutes (2002), is sufficiently broad for it to be interpreted and applied in more than one way. And some of the possible interpretations and applications might at some future date provide a basis for modification of the manner in which administrative hearings in such cases are conducted. But
such possible interpretations and applications are merely possibilities; they are not certainties. Therefore, unless and until there is some authoritative interpretation or implementation of the subject amendments directing otherwise, the most prudent course appears to be for the DOAH administrative law judges to continue to receive evidence and to continue to make "determinations" (by findings of fact or by conclusions of law) as to what constitutes the "reasonable standard of care" and as to whether a licensee "has violated the laws and rules regulating the profession."10
Alleged violations of Section 458.331(1)(m)
Turning now to the specific violations charged in the administrative complaints in these consolidated cases, attention is addressed first to the alleged violations of Section 458.331(1)(m), Florida Statutes, because those allegations present the issues that can be most quickly and easily disposed of. Section 458.331(1)(m), Florida Statutes, in pertinent part, authorizes disciplinary action against a physician who fails to keep 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."
There is very little disagreement in these cases about the nature of and the inadequacies of the Respondent's medical records concerning the six patients whose treatment forms the basis of the violations alleged in these consolidated cases. The Respondent concedes at page 38 of his proposed recommended order:
There is clear and convincing evidence that Dr. Waters failed to keep medical records in the above cases [the cases at issue here] that adequately explain why the various controlled substances were administered in each of the cases listed above. While it was possible to make assumptions in that regard, the medical record documentation as to why medication was given and a certain treatment plan was undertaken was not clear to the reviewer or the experts in this case.
In view of the above-quoted concession, there does not appear to be any need for a detailed or lengthy discussion of all of the many insufficiencies in the Respondent's medical records, but attention to a few specific examples is warranted. The record for March 30, 2002, concerning Patient D.P. is especially problematic, because it suggests that the patient was seen and treated that day, when in fact Respondent left the office before the patient arrived. It is also significant to note that all of the patients whose care forms the basis for these cases were patients for whom controlled substances were being used for the treatment of pain. With regard to all such patients, the statutory record-keeping requirements of Section
458.331(1)(m), Florida Statutes, must be read in light of the specific record-keeping requirements for such patients contained in Florida Administrative Code Rule 64B8-9.013(3)(f). All of the medical records at issue in these cases were insufficient to meet the specific record-keeping requirements for cases in which controlled substances are being used for the treatment of pain.
Briefly summarized, the record in these cases contains clear and convincing evidence that the Respondent committed each of the six violations of Section 458.331(1)(m), Florida Statutes, alleged in the Administrative Complaints in these cases.
Alleged violations of Section 458.331(1)(t)
Addressing attention now to the alleged violations of Section 458.331(1)(t), Florida Statutes, it is first noted that, although clear and convincing evidence is lacking for some of the factual details upon which Petitioner bases its arguments that Respondent violated Section 458.331(1)(t), Florida Statutes, in the course of his care and treatment of all six of the patients at issue here, there is clear and convincing evidence that Respondent departed from the statutory standard of care in his care and treatment of each of these six patients in many of the ways alleged in the three administrative complaints. Some departures from the statutory standard of care were repeated during the care and treatment of all six patients. One
such repeated departure is Respondent's failure in his treatment of all six patients to comply with the guidelines in Florida Administrative Code Rule 64B8-9.013(3) regarding the use of controlled substances for pain control. Other repeated departures from the statutory standard of care include the prescription of controlled substances to patients without obtaining an adequate history, without performing an adequate examination, without a sufficient evaluation, without formulating an adequate treatment plan, and without having any adequate justification for prescribing controlled substances.
Additional specific departures from the statutory standard of care are noted in the findings of fact regarding each specific patient. It would serve no useful purpose to repeat all of them here. Suffice it to note here that during the course of his treatment and care of each of the six patients at issue here, Respondent departed in more than one way from the statutory standard of care set forth at Section 458.331(1)(t), Florida Statutes, which requires a physician 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." Briefly summarized, the record in this case contains clear and convincing evidence that Respondent, in the course of his care and treatment of each of the six patients at issue here,
committed six violations of Section 458.331(1)(t), Florida Statutes.
Alleged violations of Section 458.331(1)(q)
The Administrative Complaints in these consolidated cases contain a total of six counts alleging violations of Section 458.331(1)(q), Florida Statutes. Discussion of the issues related to the alleged violations of Section 458.331(1)(q), Florida Statutes, has been left for last, because issues regarding the appropriate interpretation of Section 458.331(1)(q), Florida Statutes, seem to be somewhat less than well-settled.
In its Final Order in Department of Health, Board of Medicine v. Leland M. Heller, M.D., DOAH Case No. 00-4747PL, 2001 WL 666972, the Board of Medicine adopted with approval (and without modification) an interpretation of Section 458.331(1)(q), Florida Statutes, which was explained as follows by Administrative Law Judge Van Laningham in the Recommended Order in the Heller case:
There is one legal issue that merits further discussion. Based on the same alleged over-prescribing of drugs to J.B., the Department accused Dr. Heller of professional negligence in violation of Section 458.331(1)(t), Florida Statutes, and also of prescribing legend drugs "other than in the course of [his] professional practice," in violation of Section 458.331(1)(q). Given the identity of the conduct underlying both charges, it is
important to point out that Section 458.331(1)(q) does not target "mere" negligence but rather proscribes a different form of misconduct.
The wrongdoing that Section 458.331(1)(q) seeks to prevent, it bears repeating, is "prescribing . . . a legend drug . . . other than in the course of the physician's professional practice." (Emphasis added). The underlined language is the gravamen of the offense. To establish guilt, the Department must prove that the accused doctor was not practicing medicine when he prescribed the drugs in question but instead was engaged in an illicit (and probably oftentimes criminal) activity, e.g. selling narcotics to a "patient" who was not really sick but wanted the drugs for recreational purposes. No other subpart of Section 458.331(1), it may be seen, generally proscribes this type of physician misbehavior.
To help the Department prove this offense, the legislature has provided a presumption, which arises when the Department demonstrates that the accused doctor prescribed drugs "inappropriately or in excessive or inappropriate quantities[.]" Section 458.331(1)(q), Florida Statutes. In that event, it may be "legally presumed" that the doctor was not acting in the course of his or her professional practice, "without regard to his or her intent." Id.
From the plain language of Section 458.331(1)(q), considered as a whole, it is clear that the terms "inappropriate" and "excessive," taken in context, do not refer to simple breaches of ordinary and reasonable care. Such negligence is the province of Section 458.331(1)(t).
Supporting this interpretation is the common sense observation that there is no logical connection between an ill-advised prescription resulting from negligence and the conclusion that the negligent physician was operating outside the course of his medical practice. It is an undeniable and
commonly-known fact of the human condition that all doctors make a mistake now and again, and some doctors' mistakes unfortunately cause harm, for which the law provides redress. But reasonable people do not ordinarily conclude that a negligent doctor must have made his mistake other than in the course of his medical practice. To the contrary, the natural and normal assumption when contemplating medical malpractice is that the wrong occurred while the doctor was practicing medicine. (Conversely, it is counterintuitive to conceive of a doctor's dispensing drugs outside the course of his medical practice as a form of professional negligence; this is a wrongful act, to be sure, deserving of censure and sanction without question, but not one commonly thought of as malpractice.)
Further, if the terms "inappropriate" and "excessive" were construed to embrace all prescription practices that fall short of that which reasonable care requires under the circumstances, then the presumption of guilt effectively would re-define and become the offense, and Sections 458.331(1)(q) and 458.331(1)(t) would be practically indistinguishable. Because the legislature presumably did not intend that Section 458.331(1)(q) be subsumed by Section 458.331(1)(t)——which would make the former redundant——it follows that the presumption of guilt should not arise from proof of mere negligence.
The Department has proposed a novel solution to the redundancy problem. It contends that whether a prescription is inappropriate or excessive should be determined based on a universal standard of care——the same for all doctors, regardless of specialty. This would, of course, distinguish Section 458.331(1)(q) from Section 458.331(1)(t), but in a potentially anomalous way. A doctor could be deemed to have exercised reasonable care in compliance with Section 458.331(1)(t) but be found in violation of the "universal" standard under
Section 458.331(1)(q) and punished for prescribing outside the course of his medical practice! That cannot have been the legislature's intent.
To have relevant meaning in reference to the offense of prescribing drugs outside the scope of a medical practice, then, the words "inappropriate" and "excessive" should be understood to connote prescription practices that are an abuse of professional discretion, that is, so far beyond the pale that no reasonable physician could justify them. Put another way, if reasonable physicians can disagree about whether the prescription in question was inappropriate or excessive, then the presumption is not warranted, and the Department must prove a charge under Section 458.331(1)(q) with other evidence that the doctor was acting outside the course of his professional practice.
Here, the Department failed to prove, clearly and convincingly, either a "universal" standard of care respecting the prescriptions at issue (assuming for argument's sake that such is relevant, as the Department urges) or that Dr. Heller's treatment decisions were an untenable abuse of professional judgment. Further, at any rate, as set forth above, the trier has determined based on the totality of the evidence that Dr. Heller in fact treated
J.B. in the course of his professional practice.
The Board of Medicine's Final Order in the Heller
case was not appealed. But since the Final Order in the Heller case, the Board has disavowed its approval of the above-quoted interpretation of Section 458.331(1)(q), Florida Statutes, in its Final Order in Department of Health, Board of Medicine v.
Anthony Glenn Rogers, M.D., DOAH Case No. 02-0080PL (Recommended
Order issued February 21, 2003; Final Order issued February 17, 2004.) In the Final Order in Rogers, the Board of Medicine concluded that the language from Heller quoted above "is not supported by law and is rejected as a conclusion of law." In lieu of the Heller interpretation, the Board of Medicine went on to conclude in Rogers: "The more reasonable interpretation of Section 458.331(1)(q)[, Florida Statutes,] contemplates an ordinary negligence standard, and accordingly, calls for the Department to show that the physician prescribed legend drugs or controlled substances 'inappropriately or in excessive or inappropriate quantities' to a patient. Such would be considered 'other than in the course of the physician's professional practice.'"
Although the Final Order in Rogers specifically recedes from the interpretation of Section 458.331(1)(q), Florida Statutes, expressed in Heller, the Rogers Final Order is not yet truly "final," because it is presently pending on appeal before the First District Court of Appeal. In this situation it is difficult to determine whether the issues in these cases regarding Section 458.331(1)(q), Florida Statutes, should be resolved by resort to the Board interpretation in Heller, which is final, or by resort to the Board interpretation in Rogers, which is not yet, and may perhaps never become, final.
The undersigned is of the view that the Heller interpretation is better reasoned than the Rogers
interpretation. For that reason, as well as because Heller is the most recent final decision on the issue, the undersigned is of the view that the interpretation in Heller should be followed here. Applying that interpretation to the facts in these cases, the six counts alleging violations of Section 458.331(1)(q), Florida Statutes, should be dismissed because there is no clear and convincing evidence in the record of these consolidated cases that the Respondent is guilty of "[p]rescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in the course of the physician's professional practice." (Emphasis added.)11
The appropriate penalty
In a proceeding of this size and complexity (involving three administrative complaints, six patients, and a total of 18 counts of violations) it is difficult to formulate and articulate an appropriate penalty for the violations which were proved in these consolidated cases. Careful consideration has been given to the factors set forth in Section 456.072(2), Florida Statutes, as well as to the many rule-based penalty guidelines and aggravating and mitigating factors.
The evidence in these consolidated cases is sufficient to prove a total of 12 counts of statutory violations; six violations of Section 458.331(1)(m), Florida Statutes, and six violations of Section 458.331(1)(t), Florida Statutes, all involving a total of six patients. These violations demonstrate a troublesome pattern of seriously deficient record-keeping, as well as a troublesome pattern of seriously deficient patient care and treatment. In view of the nature of and the frequency of the events involved in these patterns, it appears to the undersigned that it is unlikely that any penalty short of license revocation would be sufficient to adequately protect the public. But, although revocation appears to be necessary and appropriate to protect the public, it does not appear to the undersigned to be necessary or appropriate to also impose any administrative fines. This is because it appears to the undersigned that in his care and treatment of the six subject patients, Respondent was acting in good faith and was doing what he thought was in the best interests of his patients, but unfortunately made a number of errors and omissions while attempting to care for these patients.
On the basis of all of the foregoing, it is RECOMMENDED that the Board of Medicine enter a Final Order in these cases to the following effect:
Adopting all of the foregoing findings of fact and conclusions of law;
Dismissing the six counts in the Administrative Complaints alleging violations of Section 458.331(1)(q), Florida Statutes;
Finding Respondent guilty of the six counts of violations of Section 458.331(1)(m), Florida Statutes, alleged in the Administrative Complaints;
Finding Respondent guilty of the six counts of violations of Section 458.331(1)(t), Florida Statutes, alleged in the Administrative Complaints; and
Imposing a penalty consisting of the revocation of Respondent's license to practice medicine in the State of Florida.
DONE AND ENTERED this 30th day of August, 2005, in Tallahassee, Leon County, Florida.
S
MICHAEL M. PARRISH
Administrative Law Judge
Division of Administrative Hearings The DeSoto Building
1230 Apalachee Parkway
Tallahassee, Florida 32399-3060
(850) 488-9675 SUNCOM 278-9675
Fax Filing (850) 921-6847 www.doah.state.fl.us
Filed with the Clerk of the Division of Administrative Hearings this 30th day of August, 2005.
ENDNOTES
1/ All citations to the Florida Statutes are to the current version of the Florida Statutes unless otherwise specifically indicated. Although a number of the statutes that have a bearing on the issues in these consolidated cases have been amended since the events alleged in the administrative complaints, very few, if any, of those amendments are to portions of the statutes bearing on the disposition of the issues in these consolidated cases.
2/ As used in this Recommended Order, the term "statutory standard of care" means the standard of care described in Section 458.331(1)(t), Florida Statutes, as ". . . that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances."
3/ Respondent has conceded that in his treatment of Patient
S.T. he failed to follow the guidelines in Florida Administrative Code Rule 64B8-9.013(3) for the use of controlled substances for pain control. (See paragraph 254 of Respondent's proposed findings of fact.) Respondent has also conceded a failure to follow those guidelines in his treatment of four of the other five patients; D.P., B.F., C.C., and F.K. (See paragraphs, 241, 273, 288, and 303 of Respondent's proposed findings of fact.) In addition to Respondent's concession, there is also clear and convincing evidence of these failures.
4/ Petitioner also argues that Respondent prescribed excessive amounts of several controlled substances. There is clear and convincing evidence that Respondent inappropriately prescribed controlled substances, but the evidence regarding the prescription of excessive amounts is less clear, less certain, and less persuasive. There is also expert testimony to the effect that the amounts prescribed were not excessive. Upon consideration of the totality of the evidence on the issue of whether controlled substances were prescribed in excessive amounts, it is concluded that evidence tending to support such a finding falls short of being clear and convincing. Accordingly, the evidence is insufficient to support a finding that controlled substances were prescribed in excessive amounts.
5/ While the evidence supports a finding that Patient B.F. would have benefited from a multi-disciplinary team approach, there is no clear and convincing evidence that the failure to embark upon a multi-disciplinary team approach was a departure from the statutory standard of care. In other words, while a multi-disciplinary team approach may have been the "best" approach, there is no clear and convincing evidence to the effect that a reasonably prudent physician under the same or similar circumstances would find it unacceptable to treat Patient B.F. without a multi-disciplinary team approach.
6/ The comments in Endnote 5, above, are equally applicable here.
7/ The comments in Endnote 5, above, are also applicable here.
8/ The failure to follow the rule-based guidelines in the treatment of this patient is not conceded in Respondent's proposed recommended order (as it is with regard to the other five patients), but such failure is established by clear and convincing evidence regarding this patient.
9/ The Board of Medicine views the matter otherwise. In its Final Order issued on June 17, 2004, in Department of Health, Board of Medicine v. Robert H. Hunsaker, M.D., DOAH Case No. 03- 1954PL, the Board of Medicine, in addressing the legal effect of Section 20 of Chapter 2003-416, Laws of Florida, stated: "The said amendment addresses substantive rights of a licensee rather than matters of procedure. Therefore the amendments to Section 456.073(5), Florida Statutes, are not applicable to the cases at bar." See also the Final Order issued on May 4, 2004, in Department of Health, Board of Medicine v. Thomas Patrick Trevisani, M.D., DOAH Case No.03-1952PL, reversed on other grounds, So. 2d (Fla. 1st DCA 2005).
10/ Some of my "determinations" as to whether Respondent "has violated the laws and rules regulating the profession" are located in the findings of fact portion of this Recommended Order, and other such "determinations" are located in the Conclusions of Law. The ALJ has tried to place such determinations where he believes they belong, taking into consideration both a long history of appellate court guidance on such matters and the legislative amendments discussed in paragraphs 19 through 21 of the conclusions of law, above. In any event, the placement of such determinations in one part of the Recommended Order or the other does not appear to be of any
great moment, because it is reasonable to expect that the appellate courts will continue to be of the view that, regardless of where placed and regardless of how characterized, a fact will always be a fact and a conclusion of law will always be a conclusion of law.
11/ If the Rogers interpretation were to be applied to the facts in this case, there would be little or no difference in the ultimate disposition of this case. This is because under the Rogers interpretation prescribing drugs "inappropriately" within the meaning of Section 458.331(1)(q), Florida Statutes, in the words of the Rogers Final Order, "contemplates an ordinary negligence standard, and accordingly, calls for the Department to show that the physician prescribed legend drugs or controlled substances 'inappropriately or in excessive or inappropriate quantities' to a patient." Such a "negligent" act would be, essentially, a subset of the violation encompassed by Section 458.331(1)(t), Florida Statutes, which is also primarily concerned with negligence. Stated otherwise, under the Rogers interpretation a single act of negligently prescribing a drug inappropriately would be a violation of both Section 458.331(1)(q) and Section 458.331(1)(t), Florida Statutes.
Where only a single act is proved, it would seem to be somewhat difficult to justify imposing punishment for two statutory violations resulting from a single act of negligence. In this regard it is noted that the basic facts upon which Petitioner bases its arguments that Respondent violated Section 458.331(1)(q), Florida Statutes, are, for the most part, the same basic facts upon which Petitioner also bases its arguments that Petitioner violated 458.331(1)(t), Florida Statutes.
COPIES FURNISHED:
Louise T. Jeroslow, Esquire
Law Offices of Louise T. Jeroslow 6075 Sunset Drive, Suite 201
Miami, Florida 33143
John E. Terrel, Esquire Bernabe A. Icaza, Esquire Department of Health
4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265
Larry McPherson, Executive Director Board of Medicine
Department of Health 4052 Bald Cypress Way
Tallahassee, Florida 32399-1701
Dr. John O. Agwunobi, Secretary Department of Health
4052 Bald Cypress Way, Bin A00 Tallahassee, Florida 32399-1701
R. S. Power, Agency Clerk Department of Health
4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
Timothy M. Cerio, General Counsel Department of Health
4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701
NOTICE OF RIGHT TO SUBMIT EXCEPTIONS
All parties have the right to submit written exceptions within
15 days from the date of this Recommended Order. Any exceptions to this Recommended Order should be filed with the agency that will issue the final order in this case.
| Issue Date | Document | Summary |
|---|---|---|
| Oct. 18, 2005 | Agency Final Order | |
| Aug. 30, 2005 | Recommended Order | In cases involving six record-keeping violations and six standard of care violations, the revocation of Respondent`s license is necessary to protect the public. |
DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs ERIC N. GROSCH, M.D., 04-000400PL (2004)
DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs DONALD A. TOBKIN, M.D., 04-000400PL (2004)
BOARD OF MEDICAL EXAMINERS vs. ORLANDO C. RAMOS, 04-000400PL (2004)
DEPARTMENT OF HEALTH, BOARD OF MEDICINE vs SERGE LEFEVRE ALEXANDRE, M.D., 04-000400PL (2004)
