103, Tampa, Florida 33612.
At all times material to this Complaint, Respondent treated patients at Harbour Medical Group (Clinic), located at 1930 Land O' Lakes Boulevard, Suite 6, Lutz, Florida 33549.
While practicing medicine at the Clinic, Respondent prescribed large amounts of oxycodone, Oxycontin, Ambien, Xanax, MS ER and Suboxone to his patients.
Oxycontin is a brand name of a drug that contains oxycodone and is prescribed to treat pain. Oxycontin is an extended-release medication used to provide pain relief for long periods of time, while oxycodone is an immediate release medication used to provide short-term pain relief. Oxycodone is an opioid drug, which has similar action to the drug opium. Opioid drugs are synthetically manufactured, while opiate drugs are naturally occurring, but the terms opioid and opiate are often used interchangeably. Opioid drugs are addictive and subject to abuse. According to Section 893.03(2)(a), Florida Statutes (2008-2010), oxycodone, or any salt, compound, derivative, or preparation of oxycodone, is a Schedule II controlled substance that has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States. Abuse of oxycodone may lead to severe psychological or physical dependence.
Suboxone is a brand of buprenorphine and is commonly prescribed to treat pain and withdrawal from opioids. According to Section 893.03(5), Florida Statutes (2008), buprenorphine is a Schedule V controlled substance that has a low potential for abuse relative to the substances in Schedule IV and has a currently accepted medical use in treatment in the United States. Abuse of buprenorphine may lead to limited physical or psychological dependence relative to the substances in Schedule IV.
Xanax and Niravam are brands of alprazolam (benzodiazepine) and are prescribed to treat anxiety. According to Section 893.03(4), Florida Statutes (2008-2010), alprazolam is a Schedule IV controlled substance that has a low potential for abuse relative to the substances in Schedule III and has a currently accepted medical use in treatment in the United States. Abuse of alprazolam may lead to limited physical or psychological dependence relative to the substances in Schedule III.
Morphine sulfate extended-release (MS ER) is a drug that contains morphine and is prescribed to treat pain. According to Section 893.03(2), Florida Statutes (2010), morphine is a Schedule II controlled substance that has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States. Abuse of morphine may lead to severe psychological or physical dependence.
Ambien is a brand of Zolpidem and is prescribed to treat insomnia.
According to Title 21, Section 1308.14, Code of Federal Regulations (2008-2009), zolpidem is a Schedule IV controlled substance. Zolpidem can cause dependence and is subject to abuse.
Percocet is a drug that contains oxycodone and acetaminophen, or Tylenol. According to Section 893.03(2), Florida Statutes (2009), oxycodone is a Schedule II controlled substance that has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States. Abuse of oxycodone may lead to severe psychological or physical dependence.
Methadone is prescribed to treat pain. According to Section 893.03(2), Florida Statutes (2009), methadone is a Schedule II controlled substance that has a high potential for abuse and has a currently accepted but severely restricted medical use in treatment in the United States. Abuse of methadone may lead to severe psychological or physical dependence.
Facts specific to Patient W.A.
Patient W.A. first presented to Respondent on or about March 26, 2009, with a history of neck, back and extremity pain.
Patient W.A. indicated he had been taking large quantities of Oxycontin and oxycodone 30 mg per day but wanted to undergo opioid
detoxification.
Respondent performed a physical evaluation of Patient W.A., which was unremarkable.
Medical records indicate that Patient W.A.'s heart rate and pupil dilation were not indicative of withdrawal, but Respondent diagnosed withdrawal and prescribed Suboxone 8 mg for opioid withdrawal, Xanax 1 mg and Ambien 10 mg to the patient.
Several days later on or about March 31, 2009, Respondent prescribed to Patient W.M. 90 tablets of Suboxone 8 mg and 60 tablets of Niravam 2 mg; however, there are no medical records indicating that Respondent evaluated the patient on this date.
After receiving injuries in a motor vehicle accident, W.A. presented to Respondent for a follow-up appointment on or about July 23, 2009.
At that time, Patient W.A. filled out an "update form," indicating he had pain level of 10 out of 10 without medications and a pain level of 6 out of 10 with medications.
In addition, Patient W.A. indicated that he did not have an active drug addiction.
Respondent evaluated the patient and prescribed oxycodone 30 mg and 60 tablets of Niravam 2 mg; however, the medical record does not contain a
copy of the prescription for oxycodone.
On or about August 6, 2009, Patient W.A. presented to Respondent for a follow-up appointment.
At that time, Respondent evaluated the patient and prescribed medications; however, the medical records do not identify or contain copies of the drugs prescribed.
On or about August 28, 2009, Patient W.A. presented to Respondent for a follow-up appointment.
At that time, Respondent evaluated the patient, discontinued the prescription for Niravam and prescribed methadone; however, the medical record does not contain a copy of the prescription for methadone.
Patient W.A. presented to Respondent for a follow-up appointment on or about September 24, 2009.
Medical records indicate that at that time, Respondent evaluated the
patient, discontinued the methadone prescription and prescribed 300 tablets of oxycodone 30 mg, 60 tablets of Oxycontin 80 mg, 60 tablets of Xanax 2 mg, 30 tablets of Ambien 10 mg and 100 tablets of Percocet 7.5/325.
Between on or about October 22, 2009, and on or about December 16, 2009, Patient W.A. presented to Respondent for three follow-up appointments.
At each appointment on or about October 22, 2010, and on or about
November 19, 2010, Respondent evaluated the patient and prescribed 300 tablets of oxycodone 30 mg, 90 tablets of Oxycontin 80 mg, 60 tablets of Xanax 2 mg and 30 tablets of Ambien 10 mg.
At the appointment on or about December 16, 2009, Respondent noted that the medications were effective for pain relief; however, Respondent modified the prescribed medications, but the medical records do not document what medications he prescribed.
Between on or about December 16, 2009, and on or about November 2, 2010, Patient W.A. presented to Respondent for 12 follow-up appointments.
Medical records indicate that at 11 appointments between on or about December 28, 2009, and on or about November 2, 2010, Respondent prescribed 460 tablets of oxycodone 30 mg, 150 tablets of Oxycontin 80 mg and 120 tablets of Xanax 2 mg to Patient W.A. at each appointment.
At the subsequent three appointments between on or about November 30, 2010, and on or about January 25, 2011, records indicate Respondent increased the oxycodone 30 mg prescription to 495 tablets and prescribed 150 tablets of Oxycontin 80 mg and 120 tablets of Xanax 2 mg to Patient W.A.
At a follow-up appointment on or about February 25, 2011, Respondent prescribed 495 tablets of oxycodone 30 mg, 90 tablets of Oxycontin 40 mg and 120 tablets of Xanax 2 mg to Patient W.A.
At a follow-up appointment on or about March 22, 2011, Respondent prescribed the same regimen but added 30 tablets of MS ER 30 mg.
At a follow-up appointment on or about April 19, 2011, Respondent continued the prescriptions of oxycodone 30 mg, Oxycontin 40 mg and Xanax 2mg but increased the MS ER 30 mg prescription to 90 tablets.
At a follow-up appointment on or about May 17, 2011, Respondent prescribed 495 tablets of oxycodone 30 mg, 90 tablets of Oxycontin 40 mg and 120 tablets of Xanax 2 mg and changed the MS ER prescription to 30 tablets of 100 mg.
On May 25, 2011, Respondent discharged Patient W.A. from his practice on the basis that the patient failed a urine drug screen.
Respondent failed to adequately monitor the patient's compliance with the prescription regimen.
Medical records indicate that Respondent did not require Patient W.A. to submit to any urine drug screens from April 2009 through May 2010, or from July 2010 through December 2010
Moreover, the drug screens to which Patient W.A. submitted on March 26, 2009, and June 11, 2010; and monthly between January 25 and May 17, 2011, were routinely aberrant or noncompliant.
In particular, on or about March 26, 2009, the urine test was positive
for tetrahydrocannabinol (THC), and the tests on or about January 25, March 22 and May 17, 2011, were all negative for oxycodone.
None of the urine drug tests included pH, temperature or creatinine tests to determine the legitimacy of the urine samples.
Respondent prescribed excessive and inappropriate dosages and quantities of controlled substances to Patient W.A.
Respondent inappropriately prescribed increasing amounts of opioids despite the Patient W.A's initial presentation and request to detoxify from opioids.
Respondent prescribed inappropriate combinations of controlled substances to Patient W.A.
Respondent failed to refer Patient W.A.to obtain substance abuse
counseling.
Respondent failed to obtain any laboratory studies for hepatic or renal function.
Respondent failed to adequately prescribe non-controlled substances
to Patient W.A. for the treatment of chronic pain.
Respondent failed to adequately refer Patient W.A. to obtain orthopedic spine, neurosurgery, pain management, psychiatric counseling, neurology or other appropriate medical consultations.
Respondent failed to consider epidural injections, nerve blocks or
other modalities for the treatment of Patient W.A.'s pain.
Respondent's medical records for Patient W.A. fail to include any patient records between August 28, 1998, and October 4, 2007; adequate documentation leading up to Patient W.A.'s presentation to Respondent; fail to justify the prescription of controlled substances; and fail to include documentation of all the medications Respondent prescribed.
Facts specific to Patient D.G.
Patient D.G., a 37-year-old male, first presented to Respondent on or about February 3, 2011, with complaints of anxiety, trouble concentrating, lumbosacral pain and a pain level of 7 out of 10 with pain medications.
Patient D.G. provided a medical history including arthritis but denied any history of surgical procedures and indicated that he currently was taking oxycodone 30 mg, Adderall, diclofenac and Xanax 2 mg.
Patient D.G. submitted to a multi-drug urine screen, which was positive for benzodiazepines, methadone, opiates and oxycodone.
Respondent performed a physical evaluation of Patient D.G., which revealed a blood pressure measurement of 108/78; diagnosed lumbago, anxiety and lumbar radiculopathy; and prescribed 100 tablets of oxycodone 30 mg, 30 tablets of Xanax, 30 tablets of baclofen 10 mg and 30 tablets of diclofenac 75 mg to the patient.
Less than two weeks later, Patient D.G. presented to Respondent on or about February 15, 2011, for a follow-up appointment.
At that time, Patient D.G. reported a pain level of 7 out of 10 with medication, but medical records indicated that Patient D.G.'s medications were "effectual for pain" and anxiety control.
Respondent prescribed the patient 50 tablets of oxycodone 30 mg, 150 tablets of oxycodone 30 mg, 60 tablets of Xanax 2 mg, 60 tablets of baclofen 10 mg, 60 tablets of diclofenac 75 mg and a referral to obtain an MRI.
Patient D.G. presented to Respondent for a follow-up appointment on or about March 22, 2011.
At that time, Respondent evaluated Patient D.G., diagnosed lumbago with lumbar radiculopathy and prescribed to the patient 150 tablets of oxycodone 30 mg, 50 tablets of oxycodone 30 mg, Xanax 2 mg and diclofenac 75 mg.
On or about March 25, 2011, Respondent discharged the patient after rece1vmg an anonymous telephone call that D.G. was obtaining controlled substances from another physician in Pinellas County, selling the medications and had recently abused "street drugs."
On April 11, 2011, Patient D.G. presented to the Palms of Pasadena emergency room with complaints of being sick for a couple of weeks, cough, chest discomfort, shortness of breath, anorexia and weight loss.
Patient D.G. developed renal and respiratory failure and endocarditis and died on April 21, 2011. Endocarditis is an inflammation of the serous membrane of the heart that occurs as the result of a bacterial infection and is often associated with long-term intravenous drug use.
Respondent excessively or inappropriately prescribed controlled substances despite Patient D.G.'s claim that his previous physician and prescriptions were of "no help."
Respondent excessively or inappropriately prescribed controlled substances without reviewing the patient's previous medical history and without addressing the inconsistencies in the patient's medication regimen.
Respondent failed to consider the use of alternative modalities, such as epidural injections or nerve blocks.
Respondent failed to appropriately refer the patient to other medical providers for appropriate treatment.
Respondent's medical records for Patient D.G. failed to include an
adequate patient history, an indication or justification for the multiple large prescriptions of controlled substances, a treatment plan that documents the objectives that would be used to determine treatment success and a discussion regarding inconsistencies in the patient's use of controlled substances.
COUNTONE
Petitioner realleges and incorporates Paragraphs 1 through 69, as if fully set forth herein.
Section 458.33l(l)(t)l., Florida Statutes (2008-2010), allows the Board of Medicine (Board) to discipline or suspend the license of a physician for committing medical malpractice as defined in Section 456.50, Florida Statutes (2008-2010). "Medical malpractice" is defined by Section 456.50(l)(g), Florida Statutes (2008-2010), as "the failure to practice medicine in accordance with the level of care, skill, and treatment recognized in general law related to health care licensure." Section 456.50(l)(e), Florida Statutes (2008-2010), provides that the "level of care, skill, and treatment recognized in general law related to health care licensure" means the standard of care that is specified in Section 766.102(1), Florida Statutes (2008-2010), which is set forth as follows:
The prevailing professional standard of care for a given health care provider shall be that level of care, skill, and treatment which, in light of all relevant surrounding circumstances, is recognized as acceptable and appropriate by reasonably prudent similar health care providers.
Section 458.33 l(l)(t)1., Florida Statutes (2008-2010), directs the Board to give "great weight" to this provision of Section 766.102, Florida Statutes (2008-2010).
Respondent violated Section 458.33l(l)(t)l., Florida Statutes (2008- 2010), in one or more of the following manners:
By treating Patient W.A. with excessive or inappropriate quantities of opioids despite the patient's previous request to detoxify from opioid use;
By treating Patient W.A. with excessive or inappropriate quantities of opioids despite the patient's documented opioid addiction;
By prescribing excessive or inappropriate doses and quantities of controlled substances to Patients W.A. and/or D.G. without medical justification;
By failing to obtain laboratory results for Patient W.A.; and/or
By failing to adequately monitor Patients W.A. and/or D.G.
Based on the foregoing, Respondent has violated Section 458.33l(l)(t)l., Florida Statutes (2008-2010), by committing medical malpractice.
COUNTTWO
Petitioner realleges and incorporates Paragraphs 1 through 69, as if fully set forth herein.
Section 458.33l(l)(q), Florida Statutes (2008-2010), allows the Board to discipline or suspend the license of a physician for prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in the course of the physician's professional practice. For the purposes of this paragraph, it shall be legally presumed that
prescribing, dispensing, administering, m1xmg, or otherwise prepanng 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.
Respondent prescribed controlled substances other than in the course of his professional practice, in one or more of the following manners:
By inappropriately prescribing or prescribing excessive or inappropriate quantities of controlled substances to Patients W.A. and/or D.G..;
By inappropriately prescribing or prescribing excessive or inappropriate combinations of controlled substances to Patients W.A. and/or D.G..;
By inappropriately prescribing opioids to Patient W.A., who had a history of opioid addiction; and/or
By inappropriately prescribing opioids to Patient W.A., who previously sought treatment to detoxify from opioids.
Based on the foregoing, Respondent has violated Section
458.331(1)(q), Florida Statutes (2008-2010), by prescribing, dispensing, administering, mixing, or otherwise preparing a legend drug, including any controlled substance, other than in the course of the physician's professional
practice.
COUNT THREE
Petitioner realleges and incorporates Paragraphs 1 through 69, as if fully set forth herein.
Section 458.33l(l)(nn), Florida Statutes (2008-2010), allows the Board to discipline the license of a physician for violating any provision of Chapters 456 or 458, Florida Statutes (2008-2010), or any rules adopted pursuant thereto.
Rule 64B8-9.013, Florida Administrative Code, sets forth the standards for the use of controlled substances for the treatment of pain, in part, as follows:
Standards. The Board has adopted the following standards for 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 shall document the nature and intensity of the pain, current and past treatments for pain, underlying or coexisting diseases or conditions, the effect of the pain on physical and psychological function, and history of substance abuse. The medical record also shall document the presence of one or more recognized medical indications for the use of a controlled substance.
Treatment Plan. The written treatment plan shall state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and shall indicate if any further diagnostic evaluations or other treatments are planned. After treatment begins, the physician shall adjust drug
therapy, if necessary, to the individual medical needs of each patient. Other treatment modalities or a rehabilitation program may be necessary depending on the etiology of the pain and the extent to which the pain is associated with physical and psychosocial impairment.
* * *
Periodic Review. Based on the individual circumstances of the patient, the physician shall review the course of treatment and any new information about the etiology of the pain. Continuation or modification of therapy shall depend on the physician's evaluation of the patient's progress. If treatment goals are not being achieved, despite medication adjustments, the physician shall reevaluate the appropriateness of continued treatment. The physician shall monitor patient compliance in medication usage and related treatment plans.
Consultation. The physician shall be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention must be given to those pain patients who are at risk for misusing their medications and those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder requires extra care, monitoring, and documentation, and may require consultation with or referral to an expert in the management of such patients.
Medical Records. The physician is required to keep accurate and complete records to include, but not be limited to:
The complete medical history and a physical examination, including history of drug abuse or dependence, as appropriate;
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;
Drug testing results; and
Periodic reviews. Records must remain current, maintained in an accessible manner, readily available for review, and must be in full compliance with Rule 64B8-9.003, F.A.C, and Section 458.331(l)(m), F.S.
Records must remain current and be maintained in an accessible manner and readily available for review.
Respondent violated Section 458.331(1)(nn), Florida Statutes (2008- 2010), by violating Rule 64B8-9.013, Florida Administrative Code, in one or more of the following manners:
By failing to obtain complete medical histories for Patients
W.A. and/or D.G..;
By failing to document adequate treatment plans for Patients WA. and/or D.G..;
By failing to maintain records of drugs prescribed to Patient
WA.;
By failing to adequately monitor Patients W.A. and/or D.G..;
By failing to refer Patients WA. and/or D.G.. to receive consultations from other specialists; and/or
By failing to adequately employ or offer modalities other than the use of controlled substances in his treatment of Patients W.A. and/or D.G..
Based on the foregoing, Respondent violated Section 458.331(l)(nn), Florida Statutes (2008-2010), by violating any provision of Chapters 456 or 458, Florida Statutes (2008-2010), or any rules adopted pursuant thereto.
WHEREFORE, the Petitioner respectfully requests that the Board of Medicine enter an order imposing one or more of the following penalties: permanent revocation or suspension of Respondent's license, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of the Respondent on probation, corrective action, refund of fees billed or collected, remedial education and/or any other relief that the Board deems
appropriate.
H. Frank Farmer, Jr., M.D., Ph.D., F.A.C.P.
FILED DEPARTMENT OF HEALTH
DEPUTY CLERK
CLERK AngelSande
DA TE NOV 1 5 lUlfS
gdb
PCP Date: November 10, 2011
Gavin . Burgess 1
Surgeon General
(ff\
Assistant General Cmfnsel DOH Prosecution Services Unit
4052 Bald Cypress Way, Bin C-65 Tallahassee, FL 32399-3265
Florida Bar# 013311
(850) 245-4640
(850) 245-4681 FAX
PCP Members: Leon, Bearison, Levine.
DOH vs. William R. Crumbley, M.D. Case Nos.: 2011-08058 and 2011-10987
NOTICE OF RIGHTS
Respondent has the right to request a hearing to be conducted in accordance with Section 120.569 and 120.57, Florida Statutes, to be represented by counsel or other qualified representative, to present evidence and argument, to call and cross-examine witnesses and to have subpoena and subpoena duces tecum issued on his or her behalf if a hearing is requested.
NOTICE REGARDING ASSESSMENT OF COSTS
Respondent is placed on notice that Petitioner has incurred costs related to the investigation and prosecution of this matter. Pursuant to Section 456.072(4), Florida Statutes, the Board shall assess costs related to the investigation and prosecution of a disciplinary matter, which may include attorney hours and costs, on the Respondent in addition any other discipline imposed.
