The Issue The issues in the case are whether the allegations set forth in the Administrative Complaint are correct, and, if so, what penalty should be imposed.
Findings Of Fact Petitioner is the state agency charged with licensure of nursing homes and enforcement of applicable rules and regulations. At all times material to this case, Respondent has owned and operated a skilled nursing facility (License No. 1497096) located at 2310 North Airport Road, Fort Myers, Florida 33907. Respondent is a long-term care facility that participates in the Medicare and Medicaid programs and is subject to the requirements set forth at 42 C.F.R. § 483. On January 29, 2004, an employee of Petitioner conducted an annual licensure survey of Respondent's facility and, insofar as is relevant to this proceeding, determined that the facility operation was deficient as to compliance with one requirement. Deficiencies are commonly identified on the survey form as numbered "tags" and are communicated to the facility at the time of the survey. The parties have stipulated to the following fact: "During that survey, Respondent was cited for F 309 at scope and severity of "G" as a Class II." Otherwise stated, Petitioner cited Respondent for a "Tag F 309" violation and assessed the violation as Class II. The assertion of the Tag F 309 violation is based on Petitioner's assertion that Respondent failed to provide adequate pain management services to certain patients identified in the Administrative Complaint as Residents 9, 13, and 19. The evidence establishes that routine quarterly assessments of the residents were completed as required and appropriate. There is no evidence that a "pain care management plan" is a specific plan required by any applicable rule or regulation of a relevant licensing entity. Petitioner asserts that the Respondent failed to appropriately perform "pain assessments" on the cited residents. Respondent asserts that "pain assessments" are performed on a daily basis as facility employees respond to pain expressed by residents. There is no evidence that staff is required to complete new assessments for pain management at every complaint of pain or administration of medication. At Respondent's facility, resident pain management is included within the "activity of daily living" (ADL) plan. The person responsible for maintaining the plans testified that the residents deal with pain on a daily basis, and so it was logical to include the topic within the ADL plan. Such documentation has been Respondent's practice since at least as early as 2000 without objection from Petitioner's surveyors. There is no credible evidence that placement of pain information in the ADL plan adversely affected the delivery of pain care to residents. Resident 9 Resident 9 was diagnosed with multiple sclerosis, a debilitating disease that causes chronic pain of indeterminate origin. The resident was alert, oriented, and capable of making needs known to staff. The resident was involved in pain management decisions, including refusal of medication. Pain related to multiple sclerosis is difficult to treat because it is of unknown origin. The resident's attending physician attempted to address the resident's pain through a variety of medications. Resident 9's pain was noted in his daily care plan. The resident had a Lidoderm patch and could receive Vicodin every six hours as requested. The resident could also receive Tylenol and medication for muscle spasms. Resident 9's records indicate that as of May 20, 2003, the resident's pain was assessed as daily, moderate pain (noted as "2/2" in the records). As of November 5, 2003, Resident 9's pain was assessed as less than daily, and mild (noted as "1/1" in the records). On December 7, 8, 16, and 22, 2003, Resident 9's records indicate that the resident complained of pain and received medication. A quarterly pain assessment was performed on January 28, 2004. There is no evidence that the resident was denied any requested pain medication. There is no credible evidence that the provision of additional medication would have increased the physical, mental, or psychosocial well-being of the resident. Resident 13 Resident 13 was suffering from prostate cancer and was placed on hospice care in October 2003. Resident 13 was noted as having daily severe pain as of October 30, 2003. Resident 13's care plan provided that the resident would be observed for pain and medicated "as indicated" with the effectiveness of the medication monitored. Resident 13 had a Duragesic patch releasing 75 units per hour and was receiving Roxanol (25 mg. administered under the tongue) every three hours. On the date of the survey, the surveyor heard the resident, who was in bed and attended by his wife, expressing pain. The surveyor went to the nurse's station and requested that the resident's nurse attend to the situation. At that time, Resident 13's nurse was in the dining room assisting another resident, but she was quickly relieved of that responsibility and returned to the unit to assist Resident 13. The nurse determined that the pain was the result of a catheter that had become positioned under the patient. The nurse repositioned the catheter and administered some Tylenol to the resident. After about an hour, the nurse observed the resident and there was no further discomfort noted. There is no evidence that the resident used the call bell to obtain the nurse's assistance, or that the staff failed to promptly respond to the complaint of pain related to the catheter once it was relayed to them by the surveyor. There is no credible evidence that provision of additional medication would have increased the physical, mental, or psychosocial well-being of the resident. Resident 19 At the time of the survey, Resident 19 was suffering from end-stage cardiomyopathy and renal insufficiency. The resident's attending physician testified that the most appropriate medication to address the renal insufficiency was Lasix, but Lasix would have worsened the situation related to the cardiomyopathy. Morphine could have been administered to relieve pain, but would have adversely affected the resident's pulmonary function. According to a hospital discharge summary, Resident 19 suffered from severe back pain and was discharged to Respondent with a Duragesic patch releasing 25 units per hour. Darvocet was administered in 100 mg. doses as needed for pain. As to pain, Resident 19's care plan provided that the resident was to be assessed and medicated for pain "as ordered" by the physician. The pain assessment of January 19, 2004, noted non- verbal and non-cognitive signs of pain, including grunting and screaming. The weekend prior to the survey, Resident 19 became agitated and anxious. The physician prescribed Ativan, a tranquilizer. At about 8:00 a.m. on the date of the survey, Petitioner's surveyor observed Resident 19 seated in a wheelchair, yelling that he was in pain while a staff member attempted to administer medication. The staff member administered Tylenol. At the hearing, there was testimony from staff members that Resident 19's family wanted him out of bed several times daily, particularly at mealtimes, and that the resident was unhappy with the situation. At about 9:30 a.m., the surveyor inquired of a registered nurse as to whether pain medication to the resident had been increased based on her earlier observation that the resident was complaining of pain. The nurse did not observe signs of pain and attributed the morning incident to the resident's agitation and unhappiness at being in the wheelchair rather than in bed. Subsequent observations of the resident did not indicate increased pain. The surveyor testified that she understood something "stronger" would be obtained for the resident. The greater weight of the evidence establishes that the medication available to the resident was appropriate under the circumstances of his medical condition. There is no evidence that the administration of additional medication would have alleviated pain without adversely affecting the resident's condition. There is no credible evidence that the provision of additional medication would have increased the physical, mental, or psychosocial well-being of the resident.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that Petitioner enter a final order dismissing the Administrative Complaint filed in this case. DONE AND ENTERED this 10th day of December, 2004, in Tallahassee, Leon County, Florida. S WILLIAM F. QUATTLEBAUM 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 10th day of December, 2004.
The Issue The issues to be determined are: 1) whether Petitioners’ claim for compensation is time-barred pursuant to section 766.313, Florida Statutes (2011); and 2) whether Isai Lopez Martinez, a minor child, has suffered a birth-related neurological injury as defined in section 766.302(2), compensable by the Florida Birth-Related Neurological Injury Compensation Plan (Plan).
Findings Of Fact Isai was born on September 8, 2011, at Manatee Memorial in Bradenton, Florida. His birth certificate, attached to the Petition, states that his birth weight was 6 pounds, 10 ounces. The medical records available for review included the mother’s medical records for labor and delivery, and out-patient office visits and physical therapy records for Isai. Newborn hospital records for the child were not provided. Birth was by Cesarean section at 40 weeks, because the infant was in breech presentation. Fetal heart tracings were not available for review. Apgar scores were 7 and 9, and the placenta pathology was negative for infection. Isai had out-patient evaluations for severe hypotonia (low muscle tone) and developmental delay. MRI results were normal, and although a genetic evaluation was performed, no results were available for review. Dr. Willis is an obstetrician, specializing in meternal-fetal medicine. At NICA’s request, he reviewed the medical records made available to NICA, and opined that based on the available medical records, there was no apparent obstetrical event that resulted in oxygen deprivation or mechanical trauma to the brain or spinal cord during labor, delivery, or the immediate postdelivery period. Dr. Willis’s opinion is credited. Although given multiple opportunities to do so, Petitioners have not filed anything to rebut Dr. Willis’s opinion. The Petition was filed on October 15, 2018, more than five years from Isai’s birth.
Other Judicial Opinions Review of a final order of an administrative law judge shall be by appeal to the District Court of Appeal pursuant to section 766.311(1), Florida Statutes. Review proceedings are governed by the Florida Rules of Appellate Procedure. Such proceedings are commenced by filing the original notice of administrative appeal with the agency clerk of the Division of Administrative Hearings within 30 days of rendition of the order to be reviewed, and a copy, accompanied by filing fees prescribed by law, with the clerk of the appropriate District Court of Appeal. See § 766.311(1), Fla. Stat., and Fla. Birth-Related Neurological Injury Comp. Ass'n v. Carreras, 598 So. 2d 299 (Fla. 1st DCA 1992).
The Issue At issue is whether Frisline Jeanise Victor, a minor, qualifies for coverage under the Florida Birth-Related Neurological Injury Compensation Plan.
Findings Of Fact Preliminary findings Marie J. Desir is the natural mother and guardian of Frisline Jeanise Victor, a minor. Frisline was born a live infant on September 7, 1999, at Jackson Memorial Hospital, a hospital located in Miami, Florida, and her birth weight was 3,625 grams (8 pounds, 0 ounces). The physician providing obstetrical services at Frisline's birth was Jerry Gilles, M.D., who, at all times material hereto, was a "participating physician" in the Florida Birth-Related Neurological Injury Compensation Plan, as defined by Section 766.302(7), Florida Statutes. Coverage under the Plan Pertinent to this case, coverage is afforded by the Plan for infants who suffer a "birth-related neurological injury," defined as an "injury to the brain or spinal cord . . . caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate postdelivery period in a hospital, which renders the infant permanently and substantially mentally and physically impaired." § 766.302(2), Fla. Stat. See also §§ 766.309 and 766.31, Fla. Stat. In this case, it is undisputed that Frisline is permanently and substantially mentally and physically impaired. What remains to resolve is whether her impairments resulted from an "injury to the brain or spinal cord . . . caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation." Frisline's birth and immediate postnatal course At or about 12:50 p.m., September 7, 1999, Ms. Desir, with an estimated delivery date of September 19, 1999, and the fetus at 38+ weeks gestation, presented to Jackson Memorial Hospital, in early labor. At the time, Ms. Desir's membranes were noted as intact, and vaginal examination revealed the cervix at 4 centimeters dilation, effacement at 50 percent, and the fetus out of the pelvis. Uterine contractions were noted as moderate, at a frequency of 5-6 minutes, and external fetal monitoring revealed a reassuring fetal heart rate, with a baseline in the 140-beat per minute range. Maternal history during pregnancy was significant for two hospitalizations secondary to uncontrolled diabetes. Ms. Desir was admitted, and examination revealed the baby to be approximately 4,082 grams (9 pounds). Consequently, given the suspected macrosomia (great bodily mass) of the baby, and a history of a previous infant weighing 5,300 grams (11 pounds, 11 ounces), with severe shoulder dystocia, and a borderline pelvis, it was resolved to proceed with an elective cesarean section. Ms. Desir underwent a low segment transverse cesarean section, without complication, and Frisline was delivered at 8:30 p.m. At delivery, Frisline cried immediately; showed good heart rate, respiratory effort, muscle tone, reflex irritability, and color; and did not require oxygen or resuscitation. Apgar scores were normal, and noted as 9, 9, and 9 at one, five, and ten minutes, respectively.2 Frisline was transferred to the neonatal intermediate unit for monitoring secondary to a history of maternal diabetes mellitus (DM) and insulin dependence. Admission physical was grossly normal, she remained clinically stable (with blood glucose within normal limits), and, but for a "very soft" heart murmur noted on September 8, 1999, her transition was unremarkable. Frisline was scheduled for discharge on September 10, 1999; however, due to maternal complications, she was transferred to the newborn nursery and held pending her mother's improvement. Maternal complications noted in Ms. Desir's Discharge Summary were as follows: . . . INITIALLY PATIENT WAS AFEBRILE WITH VITAL SIGNS STABLE. SUBSEQUENTLY THE PATIENT STARTED DEVELOPING TEMPERATURE SPIKES TO 102.6. EXAMINATION REVEALED POSITIVE UTERINE TENDERNESS WITH FOUL- SMELLING LOCHIA. THE PATIENT WAS DIAGNOSED WITH ENDOMYOMETRITIS ["inflammation of the muscular substance, or myometrium, of the uterus"3] AND STARTED ON GENTAMYCIN AND CLINDAMYCIN. THE PATIENT CONTINUED TO SPIKE AT 48 HOURS OF ANTIBIOTICS AND WAS STARTED ON AMPICILLIN. DURING THIS TIME, THE PATIENT DEVELOPED SOME NAUSEA AND VOMITING PROBABLY SUSPECTED SECONDARY TO POSTOPERATIVE ILEUS. NASOGASTRIC TUBE WAS NOT PLACED AS CLINICALLY PATIENT APPEARED TO BE IMPROVING WITH ADDITION OF THIRD ANTIBIOTIC. ON POSTOPERATIVE DAY SIX, THE PATIENT WITH RESOLVED ENDOMETRITIS, AFEBRILE FOR GREATER THAN 30 HOURS, TOLERATING A REGULAR DIET . . . . Therefore, on September 13, 1999, postoperative day six, Ms. Desir was discharged; however, given intervening complications, Frisline was not discharged until September 15, 1999. Notably, following her transfer to the newborn nursery on September 10, 1999, Frisline's course was unremarkable until at or about 1:30 p.m., September 12, 1999, when she appeared "jittery" and evidenced "intermittent grunting," and at 2:00 p.m., she was transferred to the neonatal intermediate care unit for observation and further management. At the time of transfer, labs were ordered, including complete blood count (CBC) and blood culture (BC), to rule out sepsis. Following admission to the neonatal intermediate unit, Frisline's examination was unremarkable, with no grunting noted, and her condition stable. Labs, including CBC and BC were unremarkable, as were follow-up labs on September 13, 1999, and Frisline was discharged on September 15, 1999. Discharge physical examination was grossly normal, but for a faint heart murmur. The cause and timing of Frisline's neurologic examination Petitioner offered no proof to address the cause and timing of Frisline's neurologic impairments. In contrast, NICA offered the medical records related to Frisline's birth and immediate postnatal course (Respondent's Exhibits 1 and 2), discussed supra; the deposition and report of Donald Willis, M.D., a physician board-certified in obstetrics and gynecology, as well as maternal-fetal medicine (Respondent's Exhibits 3 and 5). Dr. Willis reviewed the medical records related to Frisline's birth and immediate postnatal course, and was of the opinion that the records failed to reveal any evidence of trauma or oxygen deprivation during labor, delivery, or the immediate postdelivery period, to support a conclusion that Frisline suffered "birth-related neurological injury." NICA also offered a report by Michael Duchowny, M.D., a pediatric neurologist associated with Miami Children's Hospital (Respondent's Exhibit 4) who, following examination of Frisline, was of the opinion that her neurologic examination revealed a severe degree of mental and motor impairment.4 Notably, the medical records do not reveal an etiology for Frisline's neurologic impairment; Petitioner offered no competent medical evidence to support a conclusion that, more like than not, Frisline suffered an injury to the brain or spinal cord caused by oxygen deprivation or mechanical injury during labor, delivery, or the immediate postdelivery period that resulted in her neurologic impairment; and the expert opinion of Dr. Willis is consistent with the medical records and otherwise uncontroverted. Consequently, it must be resolved that the proof fails to demonstrate that Frisline suffered an injury to the brain or spinal cord caused by oxygen deprivation or mechanical injury during labor, delivery, or the immediate postdelivery period that resulted in her neurologic impairment. (See Wausau Insurance Company v. Tillman, 765 So. 2d 123 (Fla. 1st DCA 2000)("Because the medical conditions which the claimant alleged had resulted from the workplace incident were not readily observable, he was obliged to present expert medical evidence establishing that causal connection."); Ackley v. General Parcel Service, 646 So. 2d 242 (Fla. 1st DCA 1995)(determining cause of psychiatric illness is essentially a medical question, requiring expert medical evidence); Thomas v. Salvation Army, 562 So. 2d 746, 749 (Fla. 1st DCA 1990)("In evaluating medical evidence, a judge of compensation claims may not reject uncontroverted medical testimony without a reasonable explanation.").
The Issue The issues in this case, as set forth in the Amended Administrative Complaints in each respective case, are as follows: DOH Case No. 2010-01128/DOAH Case No. 11-5692 Count One. Whether Respondent, Jacinta Irene Gillis, M.D. (hereinafter referred to herein as "Dr. Gillis"), violated sections 458.331(1)(nn) and 458.326, Florida Statutes (2008 and 2009), by: Failing to diagnose patient M.G. with intractable pain prior to prescribing a controlled substance under Schedules II-V, as provided in section 893.03, from on or about December 19, 2008 through December 30, 2009; By inappropriately or excessively prescribing potentially lethal, highly abused, controlled substances, to wit: oxycodone, oxycontin, Percocet, and Valium, to M.G. without justification during the same time period; By inappropriately or excessively prescribing controlled substances to M.G. prior to exploring other treatment modalities or rehabilitation; and By failing to order a urine drug screen on M.G. at any time during her course of treatment. Count Two. Whether Dr. Gillis failed to keep legible medical records justifying the course of treatment for M.G. in one or more of the following ways: By failing to document justification for inappropriately or excessively prescribing controlled substances during her course of treatment; and By failing to document justification for not ordering a urine drug screen during the course of treatment. Count Three. Whether Dr. Gillis failed to meet the required standard of care in regards to her treatment of M.G. in one or more of the following ways: By inappropriately or excessively prescribing controlled substances without justification; By failing to confirm whether M.G. presented to a psychiatrist or psychologist after the initial referral by Dr. Gillis; By failing to order a urine drug screening of M.G. during her course of treatment; and By inappropriately or excessively prescribing controlled substances prior to exploring other modalities or rehabilitation. Count Four. Whether Dr. Gillis prescribed controlled substances, other than in the course of her professional practice, by prescribing controlled substances inappropriately or excessively in one or more of the following ways: By inappropriately or excessively prescribing controlled substances prior to exploring other treatment modalities or rehabilitation for M.G.; By inappropriately or excessively prescribing controlled substances without ordering a urine drug screening for M.G.; and By inappropriately or excessively prescribing controlled substances to M.G. without justification. DOH Case No. 2008-20661/DOAH Case No. 11-5961 Count One. Whether Dr. Gillis violated section 458.331(1)(nn), Florida Statutes (2008),1/ and Florida Administrative Code Rule 64B8-9.013(3) in one or more of the following ways: By failing to perform or document performing a complete physical exam of R.S.; By failing to explore or document exploring other treatment modalities or rehabilitation for R.S.; By failing to obtain or document obtaining a complete medical history of R.S.; By failing to document the nature or intensity of R.S.'s pain; By failing to document the current or past treatments of R.S.'s pain; By failing to document information on the effect of pain on R.S.'s physical or psychological function; By failing to develop or document developing a treatment plan for R.S.; and By failing to determine or document determining if there were any underlying or coexisting diseases or conditions for R.S. Count Two. Whether Dr. Gillis violated sections 458.331(1)(nn) and 458.326 in one or more of the following ways: By failing to diagnose R.S. with intractable pain prior to prescribing controlled substances, i.e., Percocet; By prescribing 90 tablets of Percocet 10/325 to R.S. without justification; By prescribing Percocet to R.S. without exploring other treatment modalities or rehabilitation; and By inappropriately prescribing Percocet to R.S. after R.S. reported that he was not currently being treated for pain. Count Three. Whether Dr. Gillis failed to keep legible medical records justifying the course of treatment for R.S. in one or more of the following ways: By failing to document justification for prescribing Percocet to R.S.; By failing to document a complete physical examination of R.S. prior to prescribing Percocet; By failing to document a complete medical history of R.S. prior to prescribing a controlled substance; By failing to document a urine screen on R.S.; and By failing to document a diagnosis of intractable pain for R.S. Count Four. Whether Dr. Gillis violated sections 458.331(1)(nn) and 458.326 in one or more of the following ways: By failing to perform or document performing a complete physical examination of D.H. on either of two visits; By failing to obtain or document obtaining a complete medical history on D.H.; By failing to explore or document exploring other treatment modalities or rehabilitation for D.H.; By failing to document the nature or intensity of D.H.'s pain; By failing to document the current or past treatments of D.H.'s pain; By failing to document information on the effect of pain on D.H.'s physical or psychological function; By failing to develop or document a treatment plan for D.H.; and By failing to determine or document determining if there were any underlying or coexisting diseases or conditions for D.H. Count Five. Whether Dr. Gillis violated sections 458.331(1)(nn) and 458.326 in one or more of the following ways: By failing to diagnose D.H. with intractable pain prior to prescribing a controlled substance, i.e., oxycodone; By prescribing 120 tablets of 30 mg oxycodone without justification; By prescribing 120 tablets of 30 mg oxycodone prior to exploring other treatment modalities or rehabilitation for D.H.; and By prescribing oxycodone to D.H. after D.H. reported that he was not experiencing any pain. Count Six. Whether Dr. Gillis failed to keep legible medical records justifying the course of treatment for D.H. in one or more of the following ways: By failing to document justification for prescribing 120 tablets of 30 mg oxycodone; By failing to document a complete physical examination of D.H. prior to prescribing a controlled substance; By failing to document a complete medical history of D.H.; By failing to document urine drug screening of D.H. prior to prescribing a controlled substance; and By failing to document a diagnosis of intractable pain for D.H. prior to prescribing a controlled substance.
Findings Of Fact The Department is the state agency having responsibility for monitoring health care professionals, including medical doctors. Dr. Gillis is a medical doctor licensed in Florida, North Carolina, and Iowa. She is not board-certified in any area of medicine, but claims to be "eligible" for board-certification in the field of internal medicine. Dr. Gillis received her medical degree from Meharry Medical College in Nashville, Tennessee, in 1997. She completed her internal medicine residency in 2003. Her medical career includes the following places of employment: Medical director/staff physician at Tennessee prison for women: March-August 2003; Hospitalist at Hilton Head Regional Medical Center: August 2003-February 2004; Pain management "specialist" in Atlanta, Georgia: March-September 2004; Staff physician for Illinois Correctional Facilities: September 2004-January 2005; Pain specialist/physician in Rock Island, Illinois: March-September 2005; Hospitalist at Brommen Medical Center in Bloomington, Illinois: May-August 2005; Hospitalist at Horizon Medical Center in Dixon, Tennessee: September 2005-January 2006; Pain specialist for National Health Services Clinic in Nashville, Tennessee: June-August 2006; Hospitalist at Kedlic Medical Center in Richland, Washington: September 2006-January 2007; Hospitalist at Auburn Regional Medical Center in Auburn, Washington: January-June 2007; Hospitalist at Mercy Medical Center in Sioux City, Iowa: July-August 2007; Hospitalist at Albermarle Medical Center in Elizabeth City, North Carolina: September-December 2007; Hospitalist at National Medical Affiliates in Punta Gorda, Florida: January-July 2008; Pain management specialist at UR Medical Clinic in St. Petersburg, Florida: July-November, 2008; and Pain management specialist at Dollar Medical Clinic in St. Petersburg, Florida: January 2009-October 2010. The Department is pursuing sanctions against Dr. Gillis based on her provision of medical care to three patients: D.H., and M.G. Both D.H. and R.S. are pseudonyms used by Deputies Negersmith and Johnson, respectively, as part of an undercover investigation of the clinic where Dr. Gillis was working in 2008. Their initials are used throughout this order for continuity, because all of the patient records and other evidence used those initials, rather than patient names. M.G. was a bona fide patient of Dr. Gillis's while she was operating another clinic in 2009-2010. In 2008, Dr. Gillis worked at a clinic operated by UR Medical Group, Inc., located in Pinellas Park, Florida. The clinic (referred to herein as the "UR Clinic") was owned by Renee Demasso, a non-physician. Dr. Gillis was the only medical doctor on staff at the clinic when she worked there. Another employee at the clinic was Quinton Knight, a large African- American male, who served as the office receptionist. The clinic had a "recruiter" named Jason Norris.2/ A recruiter is a person hired by the clinic to find new patients for the clinic's medical staff, i.e., for Dr. Gillis. On August 4, 2008, Negersmith, posing as D.H., was escorted to the UR Clinic by Norris. Upon arrival, he was given a patient information sheet to fill out. Norris directed him to write "severe lower back pain" on the sheet as the purpose of the visit. D.H. filled out the sheet, providing the following information: His pseudonym, address and contact information; His gender, marital status, height and weight; A fake social security number and date of birth; A fake driver's license number; His supposed occupation, i.e., a lineman for a private employer; A purported ailment, i.e., "severe lower back pain, weakness in knees" as the purpose for his visit; No insurance information; Neck/back pain and headaches as his medical history; A signature and date. All of the information provided was, of course, false. That is, D.H. was a fictitious name for a person pretending to be a patient. After filling out the form, D.H. discussed with Norris the cost of seeing the doctor. Norris said it would be a $350 charge. After approximately 45 minutes, D.H. was escorted to another waiting area, a vestibule separate from the main waiting area. After a short wait of five to ten minutes, D.H. was shown into an examination room where he met Dr. Gillis. D.H. was told to weigh himself on a floor scale and told Dr. Gillis his weight, 264 pounds. She then took his blood pressure which was 140/80. Dr. Gillis told D.H. that he might want to take some medication to lower his blood pressure. Dr. Gillis inquired as to the history of his present illness. According to the History and Physical Form (referred to herein as the patient chart) filled out by Dr. Gillis as she talked with the patient, D.H. said he had no pain (zero on a one-to-ten scale). Dr. Gillis wrote that D.H. "has difficulty explaining what he is really feeling" and that D.H. said muscle relaxers do not work for him. D.H. then told Dr. Gillis that oxycodone helps him to relax. Dr. Gillis then had D.H. perform three simple tasks: walking a short distance on his toes, walking on his heels, and raising his arms above his head. D.H. walked as directed, but he could not raise his arms higher than shoulder height because he was concealing a firearm in his waistband and raising his arms any higher would have revealed the weapon.3/ So he raised his arms up to shoulder height and then lowered them. D.H. cannot remember whether Dr. Gillis asked him why he could not raise his arms higher. Her notations on the patient chart indicate only that D.H. has less strength in his right foot (leg) and less range of motion in his left arm. At the conclusion of the examination, Dr. Gillis listed "chronic back and neck problems, chronic pain symptoms, non-specific" as the assessment and treatment plan for D.H. The lower left corner of the patient chart has an indication saying "needs records." D.H. purposefully avoided using the word "pain" throughout his examination. The only mention of pain was on the intake sheet he filled out, where he checked a box entitled neck/back pain. D.H. told Dr. Gillis that oxycodone helped him relax. She did not inquire as to whether he was taking any other medications or suggest any other modalities or treatment with D.H. After the examination, D.H. went back to the front office where he received a prescription for 120 tablets of 30 mg oxycodone and for 90 tablets of 600 mg Motrin. He handed Norris $350 in cash, which Norris then gave to Knight. No receipt was provided for the payment. D.H. then went to a local pharmacy and had the prescription filled. Pursuant to prior arrangements, he gave 60 of the oxycodone tablets to Norris for sale on the street.4/ The remaining tablets were placed into locked storage. Norris did not know D.H. was a police officer, of course. On August 27, 2008 (23 days later), D.H. appeared at the UR Clinic again. This time he was accompanied by Deputy Johnson who was posing as patient R.S. The deputies arrived at the clinic and looked for Norris, who was usually hanging around the parking lot. However, Norris was not there, and the deputies could not reach him via telephone, so they decided to go into the clinic anyway and see if they could obtain additional drugs. When D.H. and R.S. came into the clinic without Norris accompanying them, Knight became very upset and agitated. D.H. told Knight that Norris had recently changed his cell phone number, and it was not possible to contact him right then. R.S. started to walk out of the office, but Knight called him back and asked him for $350 and a copy of his identification. Knight then gave R.S. a patient information sheet to fill out. D.H. was not asked to fill out any paperwork at that time. D.H. was then escorted to the examination room where he saw Dr. Gillis again. No tests or physical examination were conducted. The only thing Dr. Gillis asked D.H. was whether he had brought his medical records with him. D.H. told her he had not had time to get them from his prior doctor yet. Dr. Gillis instructed D.H. not to come back to the clinic without his medical records. At the foot of the chart, Dr. Gillis wrote "Dr. Rew, family doctor; 2 weeks records; brought in personally." The note was not explained by Dr. Gillis. The patient chart filled out by Dr. Gillis on the second visit was extremely abbreviated in content. Under chief complaint, Dr. Gillis wrote, "patient states treatment plan is working; no complaints." The chart contains his vital signs: pulse of 142/80 and weight of 268 pounds. The history of present illness section of the form says only that D.H has a zero out of ten level of pain with treatment. She noted that has "no changes from prior testing" and added a note to "refill meds." The assessment and treatment plan section says "chronic back and neck problem." According to D.H., he never mentioned any problem to Dr. Gillis. Dr. Gillis did not inquire as to whether D.H. was currently taking any medications, but wrote, "oxycodone #120" and "Motrin 600 #90" on the current medications section of the chart. There was no physical examination of any kind performed on this visit. D.H. then went out to the office and got his prescription for 120 tablets of 30 mg oxycodone. Dr. Gillis never asked him whether he had taken all of the prior prescription, nor did she discuss pain with him. As part of his cover, D.H. intentionally avoided the use of the word "pain" when talking to Dr. Gillis. Meanwhile, R.S. completed his patient information sheet, providing the following information: His pseudonym, address and contact information; His gender, marital status, height and weight; A fake social security number and date of birth; A fake driver's license number; His occupation (carpenter work) and employer (unemployed); Purpose of visit, which D.H. listed as "stiffness in both shoulders"; No auto accident involved and no insurance available; Medical history options of high blood pressure and neck/back pain were checked in the list of various diseases and conditions listed on the sheet; An allergy to Keflex; Referred to clinic by a friend. R.S. was then taken back to an examination room where he met Dr. Gillis. He, too, contrived not to mention the word pain in his conversations with Dr. Gillis. He simply said he had a stiff shoulder. Dr. Gillis took his vital signs and had R.S. do the same physical tests that D.H. had performed in his first visit. remembers Dr. Gillis listening to his chest with a stethoscope and then examining his shoulder. The patient chart filled out by Dr. Gillis during R.S.'s visit contained the following information: "Chief complaint--Self employed; carpentry; history of surgery on back, shoulder problems one year ago; surgery and thus pain; no history of pain management." She correctly noted that R.S. was not currently on any medications. Dr. Gillis's assessment and treatment plan for R.S. was listed on the chart as chronic shoulder pain. There is no explanation for that notation. At the bottom corner of the chart, Dr. Gillis wrote "MRI of neck/shoulder; Dr. Wood, Pinellas County Orthopedic." That notation was not explained further by Dr. Gillis. R.S. went back to the front office where he was handed a prescription for Percocet 10/325, even though he never asked for medication. The Percocet was at the maximum strength (10 mg) for oxycodone content for that medication. R.S. then left the office, identified photographs of Dr. Gillis and Knight for his superiors and had no further involvement with the investigation. The testimony of Negersmith and Johnson as to their undercover actions was credible. Each of them had a clear and unambiguous memory of the events and did not appear to have any prejudices or ill intent that might negatively affect their testimony. The truth and veracity of their statements is accepted. At some point in time after the August 27, 2008, visit, the PCSO decided they had enough evidence to prosecute the UR Clinic as a "pill mill." As part of that prosecution, Dr. Gillis was pulled over in a traffic stop one day as she was leaving the clinic. After detaining her and explaining the charges that were being filed, the deputies advised Dr. Gillis to retain all patient records for patients she had been treating at the clinic. Later, Dr. Gillis cooperated with the sheriff's office and provided sets of original patient records to them. Dr. Gillis thereafter left her employment with the UR clinic and opened her own clinic. Patient M.G. presented to Dr. Gillis at her new place of employment, Dollar Medical Clinic, on December 19, 2008. Dr. Gillis was the owner and operator of this new clinic. M.G. filled out a patient information sheet which garnered the following information about him: Name, address and contact information; Marital status (married), and emergency contact information; Height, weight, and date of birth; Purpose of visit, listed as "refill on meds, follow-up on surgery." Auto accident on November 17, 2007; Insurance company information; and Medical history of neck/back pain, headaches, and arthritis. M.G. was then examined by Dr. Gillis. She filled out a patient chart for him that listed a history of surgery and treatments for pain. The patient chart lists Dr. Spuza and Dr. Nucci as physicians from whom M.G. had received care in the past. The patient chart noted that M.G. needed to be referred to a psychiatrist or psychologist as soon as possible. There was also a note indicating that M.G.'s MRI needed to be confirmed. Then there was a note written by Dr. Gillis saying "[p]atient is not going to be patient." There was no explanation as to what that note meant. The assessment and plan of treatment was then listed as "pain dependent" (although the writing on the patient chart is not very clear, and no testimony was elicited from Dr. Gillis to confirm what was written) and that the patient was advised about decreasing his pain medications. M.G. complained of pain at an eight on the one to ten scale with "treatment with oxycodone times four," presumably meaning four times per day. Upon completion of her examination of M.G., Dr. Gillis wrote him a prescription for 240 tablets of 30 mg oxycodone, 120 tablets of 40 mg oxycontin, 30 tablets of 10 mg valium, and 60 tablets of 500 mg naprosyn. According to the prescription, M.G. was supposed to take one of the oxycodone tablets every three hours, 24 hours per day, i.e., eight times per day. That was in addition to the oxycontin, which was to be taken every six hours. According to Dr. Gerber, "no pain doctor in the country would write a prescription like that." It would also be almost impossible for a patient to take all of those medications as prescribed. Approximately one month later, on January 16, 2009, M.G. returned to Dr. Gillis for the first of several follow-up visits. The patient chart filled out by Dr. Gillis that day indicates the chief complaint by M.G. to be "pain, top of buttocks radiating down leg to foot on left side." M.G. said his pain level was an eight out of ten with his medications. Dr. Gillis wrote a note to refill the medications and that there were "no acute changes" to M.G.'s condition. This time, the assessment and treatment plan was abbreviated as "A/P." This was the beginning of very cursory notes in the patient charts for M.G. The notes on the chart became shorter and less detailed as time went on. The "A/P" was listed as chronic neck pain and dental issues. Dr. Gillis then wrote prescriptions for 240 more oxycodone tablets, 120 more oxycontin tablets, 30 valium and 30 amoxicillin tablets. There is no record in the chart as to why the amoxicillin was added to M.G.'s medication regimen. There is no justification for providing essentially the same regimen of treatment when the patient was complaining of pain at a level of eight out of ten. M.G. came back for another follow-up on February 13, 2009. At that visit, Dr. Gillis charted the chief complaint as "thorac lumbar surgery [indecipherable] months ago." Again M.G. complained of a level of pain at eight out of ten when using his medications. Dr. Gillis noted her intent to refill the medications and that there were no acute changes in M.G.'s condition. His "A/P" was listed as chronic back pain. A prescription for the same medications, same doses, and same amounts as the previous visit was issued. M.G. returned on March 12, 2009, for a follow-up visit. The chief complaint at that time was "patient has difficulty [indecipherable]." Under history of present illness, Dr. Gillis wrote that M.G. has no history of pain prior to surgery and that he gets no relief from valium or Soma. There is no prescription for Soma in the records, so M.G. must have been getting that drug from some other source. There is no indication Dr. Gillis inquired as to where he got the medication, whether he was on any other medications, or how often he was taking the medication. Dr. Gillis again wrote that there were no acute changes in M.G.'s condition although he did not present with the same chief complaint. The "A/P" appears to be chronic back pain, although the writing is not clear. Prescriptions for oxycodone and oxycontin were renewed as before, and a prescription for Ambien was added. The valium prescription was not refilled. No explanation for the change in the drug regimen was provided by Dr. Gillis. On April 4, 2009, M.G. returned for another visit. This time his chief complaint was that he ran out of medications and had a seizure. There is no indication that Dr. Gillis inquired as to the type of seizure or whether M.G. had received any treatment for it. There is no evidence as to when M.G. ran out of his medications or how many pills he had taken since the prior visit. M.G. still complained of pain at a level of eight out of ten with his treatment. There is no indication of his pain level after he ran out of his medications. The "A/P" was listed as chronic back pain. The prescriptions written by Dr. Gillis for this visit were the same as the previous visit. For his next visit, May 12, 2009, there is no chief complaint listed on the patient chart. Dr. Gillis again wrote that there was no acute change in the patient's condition, that M.G.'s pain level was 6.5 out of ten with his treatment, and that the prescriptions should be refilled. The same oxycodone and oxycontin prescriptions (240 and 120 tablets, respectively) were written, along with the Ambien prescription. M.G. visited Dr. Gillis again on June 12, 2009. The chief complaint for that visit was low back pain caused by tripping over a toy car at his home. M.G.'s pulse and weight were measured, and there was a note on the chart that M.G. had "CBP" (which is presumably chronic back pain) and a toothache. A notation at the bottom of the chart said "25$," but is not explained. Dr. Gillis prescribed the same regimen of 240 pills of oxycodone and 120 pills of oxycontin. In the current medications section of the chart, Dr. Gillis wrote "Meds." That notation was not explained. As in each of the previous visits, Dr. Gillis did not perform a urine screen to determine whether M.G. had been taking the medications or not. M.G. came back to see Dr. Gillis on July 6, 2009. The chart for that visit says the chief complaint by M.G. was a surgical procedure called percantaneous distectomy and that M.G. "had care since the procedure." There is also a note that indicates "5 procedures," but the note is not explained. M.G. reported his pain level as five out of ten, with medications, and ten out of ten, without. Dr. Gillis prescribed the same, oxycodone and oxycontin medications as in the previous visits. There is no explanation as to why the medication levels were the same, even though M.G. was reporting less pain than in prior visits and had undergone surgery during the interim. M.G.'s next visit to Dr. Gillis was on August 5, 2009. His chief complaint on that day is essentially unreadable, and Dr. Gerber could not decipher it at all. There is a mention of Xanax in the chart, but its purpose is not explained. M.G.'s pain level is listed as six out of ten, with medications, ten out of ten, without. That is close to the pain levels described in the prior visit. However, without some sort of physical or functional exam or a psychological assessment, it was impossible to determine whether M.G. was functioning, no matter what his pain level. Dr. Gillis refilled the oxycodone and oxycontin prescriptions and added a prescription for ten tablets of Percocet 1/650, a minimal and almost useless dose. The "A/P" listed chronic lower back pain and seizure activities, but there was no discussion as to what seizures occurred or when. On September 9, 2009, M.G. presented with a complaint of a stiff neck. The chart mentioned an MRI, but did not explain or elaborate on it. The assessment of the patient was listed as "Ch LBP" (presumably chronic lower back pain), but there was no explanation of the relationship between the assessment and the presenting problem. There was no documentation of care in treatment on the patient chart. Dr. Gillis refilled the oxycodone and oxycontin and also added a prescription for Mobic, an anti-inflammatory medication. M.G. came back to visit Dr. Gillis on October 7, 2009. The chief complaint said M.G. had good and bad days and that the last surgery did not have good results. His pain level was down to six out of ten, with medications, and ten out of ten, without. Chronic lower back pain continues to be the assessment and treatment plan notation. Nonetheless, he was prescribed the exact same levels of oxycodone and oxycontin as all of the other visits. On November 4, 2009, M.G. returned to see Dr. Gillis. A different patient chart form was utilized by Dr. Gillis at that visit. The form includes a question, "Hello, how are you doing?" to which M.G. responded, "Terrible." M.G. said the ongoing treatment was working, but that he was not sleeping better. His pain level on that day was back up to seven out of ten, with medications. In her notes, Dr. Gillis said to "refill with adjustment with valium." There is no explanation as to why valium would be added to M.G.'s medication regimen. M.G. then visited Dr. Gillis on December 2, 2009. In response to the question about how he was feeling, M.G. said he was "planning for surgery; not doing good." He said the treatment was working and he was sleeping better. The assessment update on the chart said chronic lower back pain with exacerbations. The exacerbations were not explained. M.G. was prescribed the same medications as the previous visit. M.G.'s thirteenth and last monthly visit to Dr. Gillis occurred on December 20, 2009. When asked how he felt, M.G. answered "Alright." He said the treatment was working, but that some of his medications had been stolen. He reported not having oxycodone for nine days and oxycontin for seven days (or, possibly, not having nine oxycodone tablets or seven oxycontin tablets, the record is not clear.) He also said he had taken his medications that very day, but there was no indication in the record as to which medications he was talking about. He said his lower back pain was at a level of seven to eight on that day. Dr. Gillis did not inquire about the inconsistent statements and refilled his prescriptions anyway. The patient records for M.G. do not discuss whether he was paying for the cost of the prescriptions out-of-pocket or whether insurance was covering some of the cost. The cost of the medications would have been approximately $600.00 per month. It is clear that M.G. presented as a complex patient and was obviously receiving medical care elsewhere at the same time he was being treated by Dr. Gillis. He was apparently receiving medications from other sources at the same time Dr. Gillis was treating him. Dr. Gillis was at least somewhat aware of M.G.'s other medical care, but she never did monitoring or screening of M.G. that would have given her insight into how her treatment plan was interacting with M.G.'s other treatment. And, once Dr. Gillis saw that her treatment was not alleviating M.G.'s pain, she should have referred him to a board-certified pain management specialist. Dr. Marc Gerber was accepted at final hearing as an expert witness for the Department. Dr. Gerber is a board- certified pain management specialist who currently treats patients with pain management issues. Dr. Gerber's testimony was clear, concise, and credible. He did not appear to have any prejudice against Dr. Gillis as a person, but was very concerned about how she was practicing medicine. His testimony forms the basis for the following findings of fact. Relying upon the patient charts and patient information sheets provided by Dr. Gillis, there does not appear to have been a diagnosis of intractable pain for M.G. Intractable pain is pain for which, in the generally accepted course of medical practice, the cause cannot be removed and otherwise treated. There does not appear to have been an appropriate and complete physical examination of M.G. performed by Dr. Gillis. The oxycodone and oxycontin prescriptions for M.G. over a 13-month period are excessive. Despite her initial note wherein she advised M.G. that his medication levels must be decreased, Dr. Gillis continued the same regimen of oxycodone and oxycontin throughout M.G.'s treatment. There is no indication the medications were working, as M.G. continued to complain about pain for the entire 13 months he was under Dr. Gillis' care. Other than adding other medications, Valium, Mobic, Percocet, and Ambien for very brief periods, there was no change to M.G.'s prescription regimen. The patient charts for the visits to Dr. Gillis do not contain any justification for why the medications were prescribed in those quantities. The amount of oxycodone and oxycontin prescribed was, in itself, excessive. According to the prescriptions, M.G. was supposed to take one oxycontin every six hours. Oxycontin is a time-release medication that should only be taken once every 12 hours at most. M.G. was prescribed eight tablets of 30 mg oxycodone per day, i.e., one every four hours or two every eight hours--in addition to the oxycontin. The totality of those medications could be lethal. There are no indications in the patient charts that Dr. Gillis was taking vital signs and doing a physical evaluation of M.G. at every visit. Nonetheless, she continued to prescribe the high dosages of potentially lethal medications. Most importantly, Dr. Gillis never had a urine drug screen done on M.G. Such a test would have revealed whether M.G. was actually taking the drugs he was prescribed. It would have provided a determination of the level of drugs or other substances in M.G.'s body and then how the drugs were affecting him. A urine drug screen done at the time of M.G.'s earliest visit would have established a baseline for measuring the effectiveness and utility of future prescriptions. For a patient such as M.G., with a history of surgeries, a need for psychiatric evaluation, and a propensity to take large amounts of drugs, a urine drug screen would have been an essential element of the periodic review required for all such patients. Dr. Gillis erroneously stated that she had rejected and R.S. as patients after their first and second visits, respectively. The evidence shows that both "patients" voluntarily stopped visiting the clinic after completing their undercover work. Neither of the patients was told by Dr. Gillis not to return (although D.H. was told not to come back without bringing his medical records). Dr. Gillis did not testify at final hearing and did not provide any credible rebuttal to the facts asserted by the Department's witnesses. Dr. Gillis did demonstrate an understanding of the practice of medicine through her questioning of the Department's medical expert, but her treatment of patients R.S., D.H. and M.G. was deficient. The Department did not specifically allege, nor was there any evidence to support that Dr. Gillis intentionally practiced medicine in an inappropriate manner. However, her treatment of the patients in question indicates serious shortcomings in her ability to effectively and appropriately manage pain for her patients. Furthermore, Dr. Gillis represented herself at final hearing and, without assistance of counsel, was not able to effectively present a strong defense to the Department's allegations. Although she was given ample opportunity to testify concerning her care and treatment of the patients at issue, she declined to do so. Although the Department's perception of Dr. Gillis' treatment of D.H., R.S. and M.G. was based on its expert's review of medical records only, Dr. Gillis's refusal to testify left Dr. Gerber's perception as the only reliable source of information.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that a final order be entered by the Department of Health suspending the license of Respondent, Jacinta Irene Gillis, M.D., until such time as Dr. Gillis can demonstrate competency in the practice of medicine, especially as it relates to pain management, to the satisfaction of the Board of Medicine. It is further RECOMMENDED that the final order assess the cost of investigating and prosecuting this case and that payment of such costs be a condition precedent to ending the suspension of Dr. Gillis's license to practice. DONE AND ENTERED this 3rd day of February, 2012, in Tallahassee, Leon County, Florida. S R. BRUCE MCKIBBEN Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (850) 488-9675 Fax Filing (850) 921-6847 www.doah.state.fl.us Filed with the Clerk of the Division of Administrative Hearings this 3rd day of February, 2012.
The Issue Whether Respondent violated Sections 459.015(1)(o),(t), and (x), Florida Statutes, and, if so, what penalty should be imposed on his license to practice as an osteopathic physician.
Findings Of Fact Petitioner, the Department of Health, is the state agency charged with enforcing the statutes and regulations governing the practice of osteopathic medicine in the State of Florida. However, at the time the complaints in this cause were filed, this responsibility was assigned to the Agency for Health Care Administration. Respondent, Frank Sterling Miles, Jr., D.O., is, and has been at all times relevant to this proceeding, a licensed osteopathic physician in the State of Florida, having been issued License No. OS004200. Patient B.E., a forty-two year old female, first presented to Respondent on July 25, 1986, for an annual routine checkup. Respondent treated Patient B.E. from 1986 to 1990 and from 1992 to 1995. Because Respondent did not practice medicine from 1990 to 1992, during that time Patient B.E. was treated by Respondent's brother, Dr. Robert R. Miles. During her initial visit, Respondent took a medical history of Patient B.E. by having her complete a patient history questionnaire which included a listing of her current medications. Patient B. E. also verbally discussed with Respondent her medical history, which included a history of seizure disorders. Respondent requested from Patient B.E.'s prior physicians her medical records, which included information relative to her seizures. Tegretol and Phenobarbital (anticonvulsants) were prescribed for Patient B.E. by prior physicians for her seizures and were continued by Respondent. This course of treatment was appropriate as evidenced by the absence of seizure activity during the period of time she was being treated by Respondent. On her initial presentation to Respondent, Patient B.E.'s primary concern was severe headaches that she was experiencing. According to Patient B.E., she had a long-standing history of severe headaches and was currently taking Tylenol #3 for these headaches. Patient B.E. also complained that these headaches were a source of anxiety for her. Respondent diagnosed these headaches as migraine headaches and treated them initially by performing osteopathic manipulations. When Patient B.E.'s migraine headaches became more severe, Respondent prescribed Vicodin ES, a pain medication indicated for the relief of moderate to moderately severe pain. The Vicodin ES provided some relief for Patient B.E.'s migraine headaches if she took the medication in advance of the headache's becoming extremely severe. With the administration of Vicodin ES, it is recommended that the dosage be adjusted according to the pain and response of the patient. It is not unusual for patients experiencing severe pain to develop a tolerance to the medication and in such cases for the dosage to be increased. When Patient B.E.'s headaches became even more severe, Respondent prescribed Stadol NS, a pain medication indicated for relief of moderate-to-moderately severe pain. The Stadol NS consistently provided Patient B.E. relief from her severe migraine headaches. Like Vicodin ES, the usual dosage of Stadol ES may need to be adjusted according to the severity of the pain and the response of the patient due to the patient's developing a tolerance to the medication. Both the Vicodin ES and the Stadol NS are legend drugs. Vicodin ES contains hydrocodine bitartrate, a Schedule III controlled substance listed in Chapter 893, Florida Statutes. Hydrocodine bitatrate is a semisynthetic narcotic analgestic with effects similar to that of codeine and may be habit forming. Some side effects of hydrocodine may include, but are not limited to, sedation, nausea, vomiting, anxiety, mood changes, psychic dependence, urinary retention, and constipation. Stadol NS contains butorphanol tartrate, a synthetic opiod narcotic analgestic which is administered via a nasal spray. The most frequently reported adverse reaction of Stadol are somnolence, dizziness, nausea and/or vomiting, nasal congestion, insomnia, constipation, headache, anxiety, upper respiratory infection, sinusitis, and ear pain. During the time Patient B.E. received ongoing treatment by Respondent, there was no indication that any one of her symptoms or conditions was caused by or associated with her taking either the Vicodin ES or Stadol NS. Respondent's prescriptions to Patient B.E. for Vicodin ES were appropriate and did not exceed the recommended prescribed amount of Vicodin ES. Respondent's prescriptions to Patient B.E. for Stadol NS were appropriate and did not exceed the recommended amount. After her initial visit to Respondent and after appropriate testing, Respondent diagnosed Patient B.E. with Epstein Barr Virus Syndrome, a chronic condition. Epstein Barr Virus Syndrome weakens a patient's immune system and produces a large spectrum of diseases, including severely profound chronic fatigue, headaches, pain, and light sensitivity. In 1989 or 1990, Dr. Miles appropriately diagnosed Patient B.E. as suffering from chronic fatigue syndrome. Chronic fatigue syndrome may cause fibromyalgia-type pain, severe headaches, sore throat, sinus problems, sore muscles and joints, irritable bowel symptoms, neurological symptoms, and depression. While being treated by Respondent, Patient B.E. presented to Respondent many complaints of associated with and often experienced by individuals suffering from chronic fatigue syndrome. In addition to severe headaches, Patient B.E.'s complaints also included anxiety, ear pain, sinus problems, and irritable bowel syndrome. In addition to chronic fatigue syndrome, Respondent diagnosed Patient B.E. with somatic dysfunction, a medical term indicating the patient exhibits unverifiable complaints. Chronic fatigue syndrome and Epstein Barr Virus Syndrome are treated symptomatically because the conditions themselves can not be treated. Thus, the goal of the physician treating patients with chronic fatigue syndrome and Epstein Barr Virus Syndrome is to make the patient more functional by reducing the level and intensity of their pain. Dr. Miles saw Patient B.E. on a frequent and regular basis, during which time he monitored Patient B.E.'s condition by performing regular diagnostic testing. While being treated by Respondent, Patient B.E. was under the care of the Gulf Coast Jewish Family Services for mental health counseling. Thus, there was no need for Respondent to refer the patient for such services. However, to treat Patient B.E.'s anxiety, Respondent, at various times during his course of treatment, prescribed Valium, Xanex, and Buspar. Respondent's prescriptions of Valium, Xanex, and Buspar for Patient B.E. were appropriate and not excessive. Respondent prescribed Dyazide and Maxide, diuretic medications, to Patient B.E. These medications were prescribed by Respondent for Patient B.E.'s fluid retention and were to be taken on alternating days. Respondent's medical records for B.E. are incomplete and sparse and do not justify the prescription for Dyazide and Maxide nor the manner in which the medications were to be taken. While some of Patient B.E.'s complaints and symptoms recorded in Respondent's medical record may have been caused by Respondent's drug regimen, there is no evidence that they were, in fact, caused by the medications prescribed by Respondent. Except as noted in paragraph 23 above, Respondent's medical records justify the course of treatment of Patient B.E. In January 1994, Patient L.C. first presented to Respondent with complaints of pain, lesions, dry skin, heartburn, and pain on urination, among other complaints. Patient L.C. provided Respondent with a medical history that she had undergone silicone breast implant surgery in November 1989 and had developed chronic pain as a result of the surgery. Due to the chronic pain she was experiencing, Patient L.C. underwent removal of the silicone breast implants. However, following the removal of the implants, Patient L.C. continued to experience chronic pain and discomfort. After evaluating Patient L.C. and performing diagnostic testing, Respondent appropriately diagnosed Patient L.C. with fibromyalgia and mixed connective tissue disease related to her having had silicone implants. Patient L.C.'s condition caused her to suffer from chronic, devastating pain. A patient suffering from chronic pain for which there is no cure or treatment available is said to suffer from intractable pain. Pain is considered intractable when it is chronic pain for which there is no cure. Patient L.C. suffered from intractable pain as a result of her fibromyalgia and mixed connective tissue diseases. Typically, the goal of the physician treating such patient suffering from chronic pain is to make the patient functional, with less pain. Florida law permits the administration of controlled substances under Schedules II-IV to a person for the treatment of intractable pain. To treat the severe pain, that Patient L.C. suffered from, Dr. Miles initially prescribed Lorcet. To further assess Patient L.C. in attempting to deal with her severe pain, Dr. Miles instructed Patient L.C. to keep a journal detailing her daily functioning. Because Patient L.C. was unable to achieve adequate and effective pain relief from the Lorcet, Dr. Miles began prescribing Percodan to Patient L.C. Percodan is a pain medication indicated for the relief of moderate to moderately severe pain. With the administration of Percodan, it is recommended that the usual dosage be adjusted according to the severity of the pain and the response of the patient because the patient may develop tolerance to the medication. This is especially true with patients like Patient L.C. who suffer from chronic pain. Approximately one month after Respondent began prescribing Percodan for Patient L.C., Patient L.C.'s husband, William McGee, called Respondent to express concern about the Percodan prescriptions. At that time, Patient L.C.'s husband told Respondent that his wife was addicted to Percodan. Furthermore, Mr. McGee informed Respondent that prior to being treated by Respondent, Patient L.C. had been arrested for forging Percodan prescriptions. Despite having this information, there is no indication that Respondent inquired further into the matter. Rather, Respondent continued to prescribe Percodan for Patient L.C. and Patient L.C.'s consumption of Percodan increased during Respondent's treatment of her. Respondent's medical records for Patient L.C. reveal that on April 22, 1994, Respondent wrote a report on Patient L.C.'s medical condition in which he stated that Patient L.C. suffered from opiate addiction. Nonetheless, between February 7, 1994, and February 24, 1995, prescribed more than 1600 Percodan tablets for Patient L.C. It was not until October 1994, that Respondent, upon the recommendation of Mr. McGee, referred Patient L.C. to a pain management clinic at the University of Washington in Seattle, Washington. Patient L.C. was never treated at the pain clinic at the University of Washington, but in January 1995, Respondent admitted Patient L.C. to the University General Hospital for treatment of her chronic pain and pain management. This was almost nine months after Respondent noted in a report that Patient L.C. suffered from opiate addiction. Respondent's prescription of Percodan to Patient L.C. was excessive and inappropriate, in that Respondent: prescribed Percodan for Patient L.C.'s use at her discretion; failed to attempt less addictive alternative medication (tricyclic antidepressants) or other alternative therapies; continued to prescribe Percodan to Patient L.C. when he had been informed that she was addicted and had exhibited drug-seeking behavior; and prescribed Percodan without adequate medical justification. Respondent's medical records for Patient L.C. do not justify his course of treatment or the types and amounts of drugs and controlled substances prescribed. Respondent practiced medicine below the standard of care, in that Respondent: inappropriately prescribed Percodan to patient L.C. when he had been informed that she was addicted; failed to employ less addictive treatment alternatives for L. C.; continued Patient L.C.'s addiction by providing her with increasing amounts of Percodan; and inappropriately delayed referring Patient L.C. to a chronic pain specialist. In treating Patient L.C., Respondent failed to practice osteopathic medicine with that level of care, skill, and treatment which is recognized by reasonably similar osteopathic physicians as being acceptable under similar conditions and circumstances.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Board of Osteopathic Medicine enter a final order finding Respondent guilty of violating Section 459.015(1)(o),(t), and (x), Florida Statutes, as to Patient L.C. and guilty of violating Section 459.015(1)(o), Florida Statutes, as to Patient B.E. RECOMMENDED that the license of Respondent, Frank Sterling Miles, D.O., be placed on probation for a period of one year, beginning on the date of the final order, under the terms and conditions specified by the Board of Osteopathic Medicine. Furthermore, Respondent shall pay a fine of $3000 within ninety days of the final order. RECOMMENDED that Count One and Count Three in the matter relating to Patient B.E. be dismissed. DONE AND ENTERED this 1st day of August, 1997, in Tallahassee, Leon County, Florida. CAROLYN S. HOLIFIELD Administrative Law Judge Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-3060 (904) 488-9675 SUNCOM 278-9675 Fax Filing (904) 921-6847 Filed with the Clerk of the Division of Administrative Hearings this 1st day of August, 1997. COPIES FURNISHED: Hugh R. Brown, Senior Attorney Agency for Health Care Administration Post Office Box 14229 Tallahassee, Florida 32317-4229 Christopher J. Schulte, Esquire Bruce D. Lamb, Esquire Shear, Newman, Hahn and Rosenkrantz, P.A. 201 East Kennedy Boulevard Tampa, Florida 33601 Angela Hall, Agency Clerk Department of Health 1317 Winewood Boulevard Building 6, Room 102E Tallahassee, Florida 32399-0700 Pete Peterson, General Counsel Department of Health 1317 Winewood Boulevard Building 6, Room 102E Tallahassee, Florida 32399-0700 Dr. James Howell, Secretary Department of Health 1317 Winewood Boulevard Building 6, Room 102E Tallahassee, Florida 32399-0700 Jerome W. Hoffman, General Counsel Agency for Health Care Administration 2727 Mahan Drive Tallahassee, Florida 32308-5403 William H. Buckhalt, Executive Director Agency for Health Care Administration Board of Osteopathic Medicine Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0792
