The Issue The issue is whether the Dynamic Orthotic Cranioplasty band and related services to correct cranial asymmetry in a one-year- old child are covered benefits under the State of Florida State Employees' self-insured health plan.
Findings Of Fact At all material times, Petitioner Andres Gil has been a professor employed at Florida International University in Miami. At all material times, he has been a participant in the state group insurance programs, including the state group health insurance plan (Plan). The plan's benefits are described in the State Employees' PPO Plan Group Health Insurance Plan Booklet and Benefit Document (Benefit Document). At all material times, Petitioner's child, S. G., who was born on April 15, 2002, was a covered dependent under the Plan. At birth, S. G.'s skull appeared normal, but, at about two months of age, she began to exhibit a slight flattening of the head. The flattening became more pronounced by four months of age. The flattening was probably due to positioning of the infant at night so that she would sleep on her back and presumably be safer from sudden infant death syndrome. Petitioner and his wife took S. G. to a pediatrician, who diagnosed S. G. with severe bilateral deformational plagiocephaly. The pediatrician confirmed that S. G.'s condition was not congenital. After trying unsuccessfully conservative treatment, the pediatrician recommended the Dynamic Orthotic Cranioplasty band. This device is called a DOC Band?. The DOC Band? is among the type of devices that attempt to reshape the skull of infants through the application of focused pressure on the still-forming skull. The U.S. Food and Drug Administration has approved 38 such devices, and many of them have been used for many years. These devices include rigid helmets, which are initially fitted, but not later adjusted, and more-flexible bands, which are adjusted periodically during the period that the infants wear them. S. G. first wore the DOC Band? for four months, starting in May 2003. Although she received little benefit from the device, Petitioner, his wife, and the pediatrician decided to give the device another try, starting in September or October 2003. During the second application of the DOC Band?, which ended in February 2004, S. G.'s skull asymmetry reduced substantially. When the pediatrician first prescribed the DOC Band?, Petitioner submitted a claim to Blue Cross Blue Shield of Florida (BCBSF), which is the third-party administrator of the Plan. BCBSF denied the claim, and Petitioner appealed this decision to Respondent. By letter dated October 24, 2003, Respondent informed Petitioner that it was sustaining the determination of BCBSF. The letter states that the service or procedure was "experimental or investigational" or "not in accordance with generally accepted professional standards." On December 15, 2003, Petitioner filed a letter requesting a formal hearing. However, he never filed a claim for the second application of the DOC band. The Benefit Document lists under the "Summary of Plan Benefits" an "overview" of the "services and supplies" that are covered by the Plan. Benefit Document, p. 11. The "Summary of Plan Benefits" states that the Plan pays a percentage of the cost of "covered care and medical supplies," as long as the "care or supplies" are ordered by a covered physician and are "medically necessary" for treatment as a result of a covered accident, illness, condition, or mental or nervous disorder. Id. The Benefit Document generally covers "doctor's care" and "durable medical equipment." Benefit Document, p. 12. However, under "Limitations and Exclusions," the Benefit Document does not cover: "Services and procedures considered by BCBSF to be experimental or investigational, or services and procedures not in accordance with generally accepted professional medical standards, including complications resulting from these non-covered services." Benefit Document, p. 31. The Benefit Document defines "investigational or investigational services" as "any evaluation, treatment, therapy or device that:" cannot be lawfully marketed without approval of the US Food and Drug Administration or the Florida Department of Health if approval for marketing has not been given at the time the service is provided to the covered person is the subject of ongoing Phase I or II clinical investigation, or the experimental or research arm of a Phase III clinical investigation--or is under study to determine the maximum dosage, toxicity, safety or efficacy, or to determine the efficacy compared to standard treatment for the condition is generally regarded by experts as requiring more study to determine maximum dosage, toxicity, safety or efficacy, or to determine the efficacy compared to standard treatment for the condition has not been proven safe and effective for treatment of the condition based on the most recently published medical literature of the US, Canada or Great Britain using generally accepted scientific, medical or public health methodologies or statistical practices is not accepted in consensus by practicing doctors as safe and effective for the condition is not regularly used by practicing doctors to treat patients with the same or a similar condition BCBSF and [Respondent] determine whether a service or supply is experimental or investigational. The first two bullets of the above-cited definition of experimental or investigational services are not at issue in this case. The U.S. Food and Drug Administration has approved the DOC Band?, and it is not presently under clinical investigation or otherwise under study to determine its efficacy compared to other treatments. Nor is the safety of the DOC Band? at issue. Premature use, which is not applicable in this case, may present certain risks. Otherwise, the main risk is minor skin irritation, which obviously may be monitored. Thus, no substantial, unavoidable safety issues emerge in the use of the DOC Band? in this case. In addition to raising safety concerns, the third and fourth bullets of the above-cited definition of experimental or investigational services raise the issue of the efficacy of the DOC Band?. In 2003, the American Academy of Pediatrics released a position paper on the management of skull deformities in infants and reached no firm conclusions about the efficacy of cranial orthoses. However, a significant number of physicians find the DOC Band? to be effective in treating deformational plagiocephaly. The fifth and sixth bullets of the above-cited definition of experimental or investigational classify the DOC Band? as experimental or investigational if it is not accepted in "consensus" by practicing doctors as effective or if it is not "regularly used" by practicing doctors to treat deformational plagiocephaly. "Consensus" is defined as: "1.a. general agreement: UNANIMITY . . . [,] b. the judgment arrived at by most of those concerned[,] and 2. group solidarity in sentiment and belief." Merriam-Webster's Collegiate Dictionary (Tenth Edition 1999). Respondent has proved that DOC Band? has failed to reach these levels of acceptance and use. Although insureds may be absorbing the cost of DOC Bands? without filing claims, the fact that the Plan has received one claim for a DOC Band? in 2004 and one claim for a DOC Band? in 2003 militates against a finding of regular use, if not also widespread acceptance, of the device. Although significant numbers of physicians find the DOC Band? to be effective in treating deformational plagiocephaly, the record reveals disagreement in the acceptance of the DOC Band? and suggests that practitioners do not regularly use the device to treat deformational plagiocephaly. The research articles on which Petitioner relies assist in determining the efficacy of the DOC Band?, but do not assist in finding, at the practitioner level, the extent of acceptance and use of the device. The medical group endorsements suggest an invitation to the use of the DOC Band?, but assist little in finding the acceptance of the device by practitioners and do not assist at all in finding the extent of use of the device by practitioners. Against this evidence, the scant number of claims and the testimony of Respondent's expert witness to similar effect establish that the DOC Band? meets the fifth and sixth definitional bullets of experimental or investigational services.
Recommendation It is RECOMMENDED that Respondent enter a final order denying Petitioner's claim to the Plan for payment for the DOC Band? and related services. DONE AND ENTERED this 22nd day of November, 2004, in Tallahassee, Leon County, Florida. S ROBERT E. MEALE 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 22nd day of November, 2004. COPIES FURNISHED: William Simon, Secretary Department of Management Services 4050 Esplanade Way Tallahassee, Florida 32399-0950 Alberto Dominguez, General Counsel Department of Management Services 4050 Esplanade Way Tallahassee, Florida 32399-0950 Andres G. Gil 206 Cameron Court Weston, Florida 33326 Sonja P. Mathews Assistant General Counsel Office of the General Counsel Department of Management Services 4050 Esplanade Way, Suite 260 Tallahassee, Florida 32399-0950
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 The issue is whether Respondent, Department of Health, Board of Medicine (“Department”), was “substantially justified” under section 57.111(3)(e), Florida Statutes, in initiating the underlying action against the electrolysis license of Petitioner, Claudia Patricia Orozco-Fandino, E.O. (“Petitioner” or “Ms. Orozco”).
Findings Of Fact Case No. 18-3899PL was initiated by the Department, a “state agency” for purposes of section 57.111(3)(f). Ms. Orozco qualifies as a “small business party” as defined in section 57.111(3)(d). Because the Final Order in Case No. 18-3899PL was entered in her favor, Ms. Orozco is a “prevailing small business party” under section 57.111(3)(c)1. The Department has stipulated that the $55,185.50 in attorneys’ fees and $2,226.53 in costs claimed by Ms. Orozco are reasonable. The only issue remaining at hearing was whether the Department was substantially justified in bringing the initial action against Petitioner’s electrolysis license. Section 57.111(3)(e) states that a proceeding is “substantially justified” if “it had a reasonable basis in law and fact at the time it was initiated by a state agency.” Starting in or around 2003, Ms. Orozco owned and operated Orozco Medical Center (“OMC”), a facility that is no longer in operation. OMC provided a range of cosmetic surgical procedures, including liposuction, Brazilian butt lifts, fat transfers or fat grafting, and vampire facials. Since 2013, Ms. Orozco has been the president of Orozco Surgical Center (“OSC”), which remained in operation as of the hearing date. OSC currently provides only facials and acupuncture services.1 The Board of Medicine’s probable cause panel decides whether there is a sufficient legal and factual basis for the Department to move forward with formal charges in license discipline cases. In Ms. Orozco’s case, Department Case No. 2017-13921, the information presented to the probable cause panel included an investigative report prepared by the Department’s investigator, 1 Ms. Orozco is a licensed electrologist, acupuncturist, facial specialist, and body wrapper. Cynthia Demetrovich. This 743-page report served as the basis for the probable cause determination made by the probable cause panel on April 20, 2018. As described in the investigative report, the investigation in Department Case No. 2017-13921 began on August 9, 2017, and was triggered by Ms. Orozco’s arrest by officers of the Hillsborough County Sheriff’s Office. She had been charged with four felony counts of aggravated battery, four felony counts of practicing medicine without a license, and four felony counts of fraud.2 Between August 24, 2017, and October 16, 2017, Ms. Demetrovich and Christopher Heuerman, another Department investigator, interviewed 15 OMC patients. Patients K.H., S.H., L.H., C.W., A.M., D.A., C.P., and M.A. underwent a surgical procedure known as a “Brazilian butt lift” (“BBL”) at OMC. A BBL is a specialized fat transfer procedure that augments the size and shape of the buttocks without implants. Excess fat is removed from the hips, abdomen, lower back, or thighs with liposuction, and a portion of this fat is then strategically injected into the buttocks. All eight of the patients stated that they witnessed Ms. Orozco perform their BBL procedures. Patients K.H., S.H., L.H., C.W., and A.M. expressed their willingness to testify in court about their experiences at OMC. Patients K.H., S.H., W.P., C.W., O.H., A.M., and C.P. stated that Ms. Orozco represented herself as a doctor when they met with her at OMC. Patient P.J. stated that Ms. Orozco treated her for weight loss by injecting her with HCG and vitamin B12 at OMC. HCG, or human chorionic 2 The criminal case against Ms. Orozco was resolved by a Pre-trial Intervention Agreement. gonadotropin, is a hormone produced during pregnancy that is sometimes used as a weight loss medication. Patients T.M. and L.H. stated that Ms. Orozco gave them phentermine as an appetite suppressant at OMC. Phentermine is a prescription drug. Patient K.O. stated that she was treated by Ms. Orozco at OMC for weight loss. Ms. Orozco administered HCG injections and personally gave an appetite suppressant to Patient K.O., who could not recall the name of the suppressant. Patient O.H. stated that Ms. Orozco injected dermal fillers into her face at OMC. Patients N.M. and K.B. stated that Ms. Orozco administered vampire facials to them at OMC. A “vampire facial,” or “platelet-rich plasma facial,” is a procedure in which blood is drawn from a patient’s arm and placed in a centrifuge. The resulting platelet-rich plasma is then injected into the patient’s face. “Electrolysis or electrology” is defined by section 478.42(5) as “the permanent removal of hair by destroying the hair-producing cells of the skin and vascular system” using equipment and protocols approved by the Board of Medicine. An electrologist is not competent to perform surgical procedures such as BBLs; to treat a patient for weight loss; to prescribe or administer weight loss drugs; to inject dermal fillers; or to perform vampire facials. On August 10, 2017, the Department mailed a letter to Ms. Orozco advising her that a case had been opened against her and that she had 20 days from receipt of the letter to submit a response or schedule an interview. Ms. Orozco’s counsel responded by letter dated August 28, 2017, addressed to Ms. Demetrovich. The letter enclosed a copy of Ms. Orozco’s curriculum vitae and stated that she intended to “vigorously defend the criminal allegations which were the subject of her arrest.” Counsel noted that formal charges had yet to be filed against Ms. Orozco and concluded by requesting the Department “to refer to my correspondence in the related Department of Health Investigation No. 2016-16104.” The referenced correspondence included two letters from Ms. Orozco’s attorneys. Both letters were addressed to Ms. Demetrovich and addressed an earlier Department investigation of Ms. Orozco. The first letter, dated July 7, 2016, included a three-page chart identifying the names of patients, their dates of surgery, and the names of the physicians who performed the surgeries. The chart listed 46 patients whose procedures were stated to have been performed by Mark Kantzler, D.O., and 12 patients whose procedures were stated to have been performed by Amina Edathodu, M.D. The second letter, dated August 26, 2016, asserted that Ms. Orozco was a “certified Surgical First Assistant,” and set forth the job description and duties of a surgical assistant as defined by the American Board of Surgical Assistants and the Association of Surgical Assistants. The letter stated that all surgical procedures at OMC were performed by licensed physicians with assistance from certified surgical assistants, including Ms. Orozco. The August 28, 2017, letter from Ms. Orozco’s counsel was included in Ms. Demetrovich’s investigative report. However, the referenced letters of July 7, 2016, and August 26, 2016, were not included in the investigative report and therefore were not placed before the probable cause panel. Ms. Demetrovich testified that she is not allowed to “share cases,” i.e., to mix materials from separate investigations into a single file. Because the letters dated July 7, 2016, and August 26, 2016, were in reference to Department Case No. 2016-16104, Ms. Demetrovich did not include them in her investigative report for Department Case No 2017-13921. The investigative report included the complete medical records, including before and after photographs, received from OMC for Patients K.H., S.H., C.W., O.H., N.M., K.B., T.M., A.M., D.A., A.B., K.O., P.J., C.P., and M.A. The investigative report also included the Hillsborough County Sheriff’s Office criminal report affidavit and arrest report for Ms. Orozco. The criminal report affidavit named four additional patients who told detectives that Ms. Orozco performed their BBL or liposuction procedures at OMC. All four patients named in the criminal report affidavit stated that Ms. Orozco led them to believe she was a medical doctor who could perform the surgical procedures offered by OMC. The patients variously stated that Ms. Orozco referred to herself as “doctor,” conducted the preoperative consultations, or showed them pictures of previous surgeries she had performed. Patient N.M. stated that another non-physician, Marlon Barcelo, performed the fat removal in her procedure. Mr. Barcelo was a surgical assistant employed by Ms. Orozco. Patient N.M. stated that Ms. Orozco performed the fat injection portion of the procedure. Patients U.L., A.B., and H.P. stated that their liposuction procedures were performed entirely by Ms. Orozco. The criminal report affidavit stated that on April 22, 2016, a Hillsborough County Sheriff’s detective interviewed Dr. Edathodu, who stated that she had worked at OMC. Dr. Edathodu referred to Ms. Orozco as a “doctor” and stated that Ms. Orozco had performed fat removal and injection procedures at OMC. Dr. Edathodu reviewed the medical records for Patient N.M., which indicated that Dr. Edathodu performed her procedure. Dr. Edathodu denied to the detective that the signatures and handwriting on N.M.’s medical records were hers. The criminal report affidavit stated that on May 5, 2017, a Hillsborough County Sheriff’s detective interviewed Dr. Kantzler, who stated that he would be present in the OMC facility while liposuction procedures were performed, but that the surgical assistants performed them. The criminal report affidavit stated that Patient A.B. reported that about two weeks before she met with the detective, she received a text message from Ms. Orozco. The text message stated that if Patient A.B. got a phone call from anyone, she should tell them that Dr. Kantzler had performed her surgery. On December 27, 2017, counsel for the Department provided Ms. Orozco’s counsel with a CD copy of the Department’s complete investigative file for Department Case No. 2017-13921. In the accompanying letter, counsel for the Department reminded Ms. Orozco’s counsel that he had 20 days in which to file a written response to the information contained in the investigative file, pursuant to section 456.073(10). On April 20, 2018, the Department’s probable cause panel met to review and discuss the investigative report. The panel found probable cause for both counts of the Administrative Complaint. At the hearing in the instant fee case, Ms. Orozco contended that the probable cause panel’s determination was based on an incomplete record. She argued that the Department’s investigative report omitted exculpatory material and that Ms. Demetrovich failed to make inquiries that might have led the probable cause panel to a different decision. Ms. Orozco noted that Ms. Demetrovich began investigating OMC in 2016, well before the investigative report in Department Case No. 2017- 13921 was prepared. Ms. Orozco testified that Ms. Demetrovich visited the offices of OMC on August 11, 2016, in the guise of accompanying a Department dispensing practitioner inspector. While at OMC, Ms. Demetrovich interviewed Ms. Orozco directly and took photographs of every room in the building. She photographed the surgical suite and the equipment therein. Ms. Demetrovich testified that she did not interview Ms. Orozco on August 11, 2016. She testified that if any photographs were taken during the visit, they were taken by the other inspector. Ms. Orozco contended that at the time she submitted her investigative report, Ms. Demetrovich was aware that the OMC surgical suite contained a drape between the patient’s head and the surgical field that wholly obstructed the patient’s view of who was performing their surgery. Ms. Orozco contended that if this information had been provided to the probable cause panel, the panel would have discounted the numerous patient statements attesting that Ms. Orozco performed their surgeries. Ms. Orozco also questioned why Ms. Demetrovich did not ask the patients how they could possibly know Ms. Orozco was performing their procedures when they could not see the surgical field. Ms. Orozco noted that the 2016 investigation prompted her counsel to submit the July 7, 2016, and August 26, 2016, letters referenced above. Ms. Orozco questioned why the contents of those letters were not included in the investigative report. Ms. Orozco pointed out that the medical records that were included in the investigative report were replete with indications that the surgeries were performed by Dr. Edathodu and Dr. Kantzler, including the consent forms in which the patients expressly acknowledged the name of the physician who would perform the procedure. Ms. Orozco contends that Ms. Demetrovich was obliged to confront the patients with this evidence and ask them to reconcile it with their statements that Ms. Orozco performed their procedures. Ms. Orozco argued that Ms. Demetrovich should have interviewed Dr. Edathodu, Dr. Kantzler, and other members of the OMC staff before completing her investigative report. Ms. Demetrovich testified that Dr. Edathodu evaded several attempts to interview her. Ms. Demetrovich stated that she interviewed Dr. Kantzler in another case, but did not include a summary of that interview in the investigative report of this case. Ms. Demetrovich testified that neither Dr. Edathodu nor Dr. Kantzler submitted affidavits in relation to this case. Ms. Demetrovich testified that her role in the investigation of Ms. Orozco and OMC did not include evaluating records obtained from the subjects of the investigation, or their attorneys, apart from checking for completeness. She testified that the determination as to whether to pursue disciplinary action based on the investigation rested with the Department’s attorneys. Ms. Demetrovich’s testimony as to the limits of her job responsibilities is credited. The investigative report included an identification key with the full names of the patients. Ms. Demetrovich acknowledged that she neglected to include the full names of Patients W.P. and L.H. in the identification key. It is found that the information before the probable cause panel was sufficient to support the panel’s decision to pursue an Administrative Complaint against Ms. Orozco. The investigative report included interviews with eight OMC patients who stated to the Department’s investigators that Ms. Orozco had performed BBLs on them. All eight patients stated that they witnessed Ms. Orozco perform the procedure. Five of the eight stated their willingness to testify against Ms. Orozco in any future court proceeding. Seven patients stated that Ms. Orozco had presented herself to them as a physician. Four other patients interviewed by the Department’s investigators stated that Ms. Orozco had provided them with injections of medications. Two patients stated that Ms. Orozco had performed vampire facials on them. One patient stated that Ms. Orozco administered dermal fillers to her. Four patients interviewed by detectives from the Hillsborough County Sheriff’s Office stated that Ms. Orozco presented herself as a medical doctor. Three of the four stated that Ms. Orozco performed their liposuction procedures. The patient statements alone justified a finding of probable cause. Ms. Orozco pointed to contrary evidence in the investigative report, such as the patient consent forms that clearly indicated the surgeries were performed by Dr. Edathodu and Dr. Kantzler. Such documentation might weigh against the patient statements, but is insufficient to support a finding that the probable cause panel should have disregarded the word of 19 patients that Ms. Orozco performed procedures on them that exceeded the scope of her professional licensure. Further, the probable cause panel would have been justified in discounting the patient consent forms in light of the statements the two physicians gave to the Hillsborough County Sheriff’s detectives that surgical procedures were in fact performed by Ms. Orozco and/or Mr. Barcelo. None of the items that Ms. Orozco claims were omitted from the investigative report would change this finding. The July 7, 2016, letter from her counsel naming the patients and their respective physicians was of no more significance than the signed consent forms that were included in the report. The August 26, 2017, letter setting forth the definitions of “surgical assistant” and stating that licensed physicians performed all surgeries at OMC merely contradicted the patients’ statements. It did not disprove or invalidate the patients’ statements in such a way as to justify their disregard by the probable cause panel. Finally, it was a matter of dispute whether Ms. Demetrovich had in her possession photos of the OMC surgical suite that she declined to include in the investigative report. Nothing prevented Ms. Orozco from submitting such photos on her own if she believed they would help her case. Such photos might raise questions, but again would not disprove or invalidate the statements of 19 patients to the degree that the probable cause panel could reasonably disregard the patients’ statements to the investigators and detectives.3
The Issue The issue in this case is whether Kayla Mackenzie Stowers sustained a birth-related neurological injury.
Findings Of Fact Tatiana C. Stowers and Robert M. Stowers are the natural parents of Kayla Mackenzie Stowers, a minor. Kayla was born a live infant on October 12, 2009, at Orange Park Medical Center, a licensed hospital located in Orange Park Florida. Eric J. Edelenbos, M.D., provided obstetric services at the birth of Kayla, and at all times material to this proceeding, was a “participating physician” as defined in section 766.302(7), Florida Statutes. Kayla weighed 3,078 grams at birth. On October 12, 2009, Mrs. Stowers, who was at full term, was admitted to Orange Park Medical Center at 6:28 a.m., for induction of labor. Her prenatal course had been uneventful. The baby?s baseline fetal heart rate on admission was 150 bpm, and the fetal heart rate monitor did not show any fetal distress during labor or delivery. At 8:05 a.m., Pitocin was administered to augment Mrs. Stowers? labor. During her labor, the dosage of Pitocin was increased. At 1:48 p.m., Dr. Edelenbos ruptured Mrs. Stowers? membranes, and the medical records indicate that the amniotic fluid was clear and odorless. At 9:40 p.m., Mrs. Stowers delivered Kayla by normal spontaneous vaginal delivery. At birth, Kayla?s mouth and nose were suctioned, but no other resuscitative measures were needed or administered in the delivery room. No complications were noted at her birth, and she was in stable condition. Kayla?s Apgar scores at one and five minutes were eight and nine respectively. At 10:30 p.m., Kayla was noted to have respiratory distress. Her left nasal passage was tight and her right nare was patent. She was transferred to the hospital?s neonatal intensive care unit. On October 13, 2009, at 12:05 a.m., Kayla was placed on a nasal cannula and an IV was started. Antibiotics were given at 12:20 p.m., and Neo-Synephrine was administered for nasal stuffiness. By 3:45 p.m., on October 13, 2009, Kayla had increased retractions and grunting and was placed on neonatal CPAP at 100% oxygen. During the evening of October 13, 2009, Kayla experienced two apneic episodes with jerking movements of her arms and leg. On October 14, 2009, Kayla was on CPAP for four hours and then intubated due to the apneic episodes the previous evening. A chest X-ray taken of Kayla on October 13, 2009, was within normal limits. On October 14, 2009, Kayla had a normal neonatal head ultrasound. On October 15, 2009, it was noted that Kayla had not experienced any abnormal movements for 24 hours. At 6:00 p.m., on October 17, 2009, Kayla experienced periodic episodes of jerking of hands and legs, in addition to the arching of her back. On October 18, 2009, Kayla had jerky movements of all extremities, including her eyes rolling back. The movements stopped with restraint, but were not typical seizure-like movements. On October 19, 2009, due to suspected seizures, respiratory distress, and suspected sepsis, Kayla was transferred from Orange Park Medical Center to Wolfson Children?s Hospital for further workup. An EEG performed on Kayla on October 20, 2009, was within normal limits. A follow-up video EEG on November 4, 2009, was normal. An MRI was done on Kayla on October 21, 2009, and the followings findings were reported: Moderate image degradation secondary to patient?s motions. Normal variant cavum septus pellucidum and cavas vergae. Prominent extra-axial fluid at the anterior aspect of both middle fossae, and with „apparent? suboptimal opoerculation of the Sylvian fissures ? clinical signicance. Followup US may be helpful for further evaluation. Remainder of the examination appears otherwise unremarkable. Kayla?s attending physician at Wolfson Children?s Hospital indicated in her discharge summary dated November 10, 2009, that the MRI was normal. On December 9, 2009, Kayla was taken to the emergency room at Wolfson Children?s Hospital. While in the emergency room, Kayla experienced apneic episodes that required intubation. She was admitted to Wolfson Children?s Hospital. While admitted to Wolfson Children's Hospital, Kayla had abnormal movements that were nonspecific and not due to seizures. Kayla was discharged on December 22, 2009. In his discharge summary, Clifford David, M.D., summarized the hospital course as it related to the seizure-like activities. Neurology-wise, the patient was again worked up for this possible seizure-like activity, which was possibly due to reflux. This workup included another EEG and MRI. The CT of the head that was done on admission was reported as positive for a remote area of ischemia involving the basal ganglia but repeat MRI on admission showed no area of acute ischemia. The patient was witnessed to have back arching and head extension with some clenching of the arms and chest, again unsure whether this was seizure versus reflux versus obstructive airway. Neurology examined the patient and EEG showed no epileptiform discharges although was limited secondary to movement artifact. The repeat MRI referenced in Dr. David?s discharge summary was done on December 12, 2009. The findings of this MRI indicated that there was no acute ischemic event. Respondent retained Donald C. Willis, M.D., to review the medical records for Kayla. Dr. Willis reviewed the fetal heart rates of Kayla as recorded by the fetal heart rate monitor during labor. It is Dr. Willis? opinion that the fetal heart rate monitor did not show any fetal distress during labor. On the issue of whether there was an obstetrical event which resulted in loss of oxygen or mechanical trauma to Kayla during labor or delivery, Dr. Willis opined: In summary, there was no fetal distress during labor. The baby was not in distress at birth. Apgar scores were 8/9. Immediately after delivery, the baby was placed on the mother?s abdomen for bonding. The newborn course was complicated by a complex history of apnea episodes, respiratory distress and possible seizures. EEG?s and MRI studies were normal. There was no apparent obstetrical event that resulted in loss of oxygen or mechanical trauma to the baby?s brain during labor or delivery. Raymond J. Fernandez, M.D., a pediatric neurologist, reviewed Kayla?s medical records and examined Kayla on April 30, 2013. He opined as follows: There is ample evidence for substantial mental and motor impairment, but this is of unknown etiology. There is no evidence in the medical record for oxygen deprivation or mechanical injury of brain or spinal cord during labor, delivery, or the immediate post delivery period that explains Kayla?s substantial and global impairment. Petitioners have presented no expert opinions that refute the opinions of Dr. Willis and Dr. Fernandez. The opinions of Dr. Willis and Dr. Fernandez that Kayla?s mental and motor impairments are not due to oxygen deprivation or mechanical injury of the brain or spinal cord during labor, delivery, or the immediate post delivery period are credited.
The Issue When, as here, obstetrical services were not provided by a "participating physician" at the infant's birth, does the administrative law judge have jurisdiction to resolve whether the Respondent may, nevertheless, be estopped to deny coverage under the Florida Birth-Related Neurological Injury Compensation Plan (Plan), and, if so, whether the proof supports a claim of estoppel. If the proof supports a claim of estoppel, whether Austin K. Joshnick (Austin), a minor, suffered a "birth-related neurological injury," as defined by the Plan.
Findings Of Fact Preliminary findings Craig Joshnick and Debbie Joshnick are the natural parents and guardians of Austin K. Joshnick, a minor. Austin was born a live infant on January 18, 2001, at Morton Plant Hospital, a hospital located in Pinellas County, Florida, and his birth weight exceeded 2,500 grams. None of the physicians who provided obstetrical services during Austin's birth (Doctors Michael A. Dawson, David O. Peterfreund, or Patricia St. John) were "participating physician[s]" in the Florida Birth-Related Neurological Injury Compensation Plan, as defined by Section 766.302(7), Florida Statutes.4 Coverage under the Plan In resolving whether a claim is covered by the Plan, the administrative law judge must resolve "[w]hether the injury claimed is a birth-related neurological injury"5 and "[w]hether obstetrical services were delivered by a participating physician in the course of labor, delivery, or resuscitation in the immediate postdelivery period." § 766.309(1), Fla. Stat. An award may be sustained only if the administrative law judge concludes that the "infant has sustained a birth-related neurological injury and that obstetrical services were delivered by a participating physician at the birth." § 766.31(1), Fla. Stat. In this case, Petitioners and Intervenors are of the view that the claim is compensable since, in their opinion, Austin suffered a "birth-related neurological injury" (because he suffered an "injury to the brain . . . caused by oxygen deprivation or mechanical injury occurring in the course of labor, delivery, or resuscitation in the immediate postdelivery period . . . which render[ed] . . . [him] permanently and substantially mentally and physically impaired"), and because, while obstetrical services were not rendered by a "participating physician" at Austin's birth, Respondent is estopped from denying coverage on that basis. In contrast, NICA is of the view that the claim is not compensable since, in its opinion, Austin did not suffer a "birth-related neurological injury" (because his impairments are not associated with any event that occurred during labor, delivery, or resuscitation, and because Austin is not permanently and substantially mentally and physically impaired), and because obstetrical services were not rendered by a "participating physician" at Austin's birth. As for the claim of estoppel, NICA is of the opinion that the administrative law judge is without jurisdiction to address the issue and, if subject to resolution in the administrative forum, the facts do not support a claim of estoppel. Here, for reasons appearing in the Conclusions of Law, it is concluded that the issue of estoppel is appropriately resolved in the administrative forum. As for the claim of estoppel, it must be resolved, based on the Findings of Fact and Conclusions of Law which follow, that the record does not support such a claim. Consequently, given the lack of a participating physician at birth, the claim is not compensable, and it is unnecessary to address whether Austin suffered a birth-related neurological injury. Findings relating to Austin's birth and the giving of NICA notice by the hospital At or about 11:30 p.m., January 16, 2001, Mrs. Joshnick (with an estimated date of delivery of February 28, 2001, and the fetus at 34 weeks' gestation) experienced the onset of severe abdominal pain and was advised by her obstetrician (Dr. Peterfreund), to proceed to the hospital for evaluation. Mrs. Joshnick's husband called 911, and Mrs. Joshnick was transported by ambulance to Morton Plant Hospital, where she was received at 1:04 a.m., January 17, 2001. On arrival, Mrs. Joshnick complained of uterine cramping (since 11:30 p.m., January 16, 2001) and severe pain. Initial evaluation revealed the membranes were intact, no vaginal bleeding, and the cervix at 1 centimeter dilation, effacement at 30 percent, and the fetus at -3 station. Evaluation further revealed the fetus was active, and fetal monitoring revealed a reassuring fetal heart rate, with a baseline of 145-155 beats per minute. Mrs. Joshnick was admitted for evaluation and pain relief, and at 7:50 a.m., Terbutaline was started to discourage premature labor. Evaluation by renal ultrasound was negative, without evidence of stone, mass, or hydronephrosis, and urinalysis failed to reveal any evidence of infection. Nevertheless, Mrs. Joshnick was started on antibiotics, with the expectation that if her pain was associated with a urinary tract infection, it would resolve with the antibiotics. However, Mrs. Joshnick's abdominal pain persisted, and at 5:00 p.m., her attending obstetrician (Dr. Dawson) made the following observations: . . . abd[ominal] pain - ? etology- doubt kidney stone or U[terine] T[ract] I[nfection] @ present . . . in light of fetal tachycardia (although variability reassuring) and abdominal pain w/uterine irritability - must consider possible abruption or chorioamnionities [an infection of the placental and fetal membranes] . . . . D[iscussed]/W[ith] pt. above differential . . . [and] decision made to proceed w/amnio[centesis] to evaluate F[etal] L[ung] M[aturity]/infection. At 6:30 p.m., the amniocentesis was performed by Dr. Dawson, with Dr. St. John assisting. The amniocentesis revealed a large number of maternal blood cells, and Dr. Dawson made the following observations: . . . in light of continued pain/uterine irritability & blood on amnio & fetal tachycardia consider at least partial placental separation - will plan for delivery @ this time by induction[.] Will monitor baby closely for sym[ptoms] of intolerance to labor or fetal distress. Pt & husband aware of R[isks]/B[enefits]/A[lternatives] of expectant mgmt vs active induction/augmentation of labor of preterm infant. They are aware of risks of fetal lung immaturity, interventricular hemorrhage & necrotizing enterocolitis. They were understanding & agree w/plan to proceed w/induction of labor. Will start Petocin for augmentation. At 7:15 p.m., Mrs. Joshnick was admitted to labor and delivery for active induction/augmentation of labor. Following admission, at or about 10:00 p.m., the labor and delivery nurse on duty at the time, Cynthia Collins, R.N., presented three forms for Mrs. Joshnick or, if she were unable to do so, Mr. Joshnick's signature: an Informed Consent for Epidural Anesthesia Authorizing Anesthesia Associates of Pinellas County to administer an epidural anesthetic; a Record of Informed Consent and Consent for Procedure, authorizing Mrs. Joshnick's obstetrician to perform a vaginal delivery with possible episiotomy, forceps-assisted vaginal delivery, or vacuum extraction or cesarean section, and acknowledgment of receipt of a "NICA Pamphlet"; and a Record of Informed Consent for Procedure, authorizing Austin's circumcision. (Petitioners' Exhibit 2, Tab 2, page 5, and Tab 3, pages 3 and 4). Mrs. Joshnick signed the consent for epidural anesthesia, and Mr. Joshnick, who was present at the time, signed the consent for procedure and acknowledgment of receipt of the NICA pamphlet, as well as the consent for Austin's circumcision. Notably, it is the circumstances surrounding the giving of NICA notice, discussed infra, which form the predicate for Petitioners' claim of estoppel.6 At or about 2:17 a.m., January 18, 2001, following execution of the consents, hydration and other preparations, epidural anesthetic was started, and, at 3:30 a.m., Petocin was started via pump. Thereafter, Mrs. Joshnick's labor steadily progressed, and at 12:46 p.m.,7 Austin was delivered.8 Petitioners' claim of estoppel In this case, Petitioners' claim of estoppel, although occasionally blurred, is two-fold. First, Petitioners contend that certain comments made by Nurse Collins when she delivered the NICA pamphlet, together with Mrs. Joshnick's reliance on those statements in deciding not to insist on a cesarean section, support a finding of coverage by estoppel. On that issue, Mrs. Joshnick offered the following testimony, at hearing: Q. Did you have medical care during the pregnancy? A. Yes. * * * Q. . . . who was your primary obstetrician? A. Dr. St. John. * * * Q. On one of your initial visits, did Dr. St. John discuss anything with you? A. Yeah. She discussed the fact that I had a small pelvis and that they had to use smaller speculums, so must likely I'd be having a C-section. * * * Q. . . . [A]t the time you got the NICA pamphlet [were you in pain?] A. Oh, yeah. I was out of it. I would say I was in severe pain. Q. Had you been sedated? A. No. I wasn't given any drugs up until -- you know, after that pamphlet and signatures came. Q. No drugs for pain? A. No. Q. And you were in substantial pain? A. Yes. Q. In fact, did you sign the receipt for the NICA pamphlet? A. I think I had Craig handle that. I believe Craig signed for it . . . . * * * Q. What did Nurse Collins say to you about the NICA pamphlet? A. She said it was like an insurance policy. We were covered if anything were wrong with the baby at delivery. Q. Okay. Had Dr. St. John mentioned any -- for reasons to do a vaginal delivery in your discussions? Did she mention any problems you might have? A. She -- when I questioned her about the C- section, she said that I was in grave condition and I had lost too much blood. And I said, really, because I didn't realize I had lost that much blood. So I was like, okay. I believed that I was in grave condition and lost too much blood to have a C-section. Q. So in short, you understood that there were dangers to you from a Cesarean Section? A. Yes. Q. Okay. At the same time, you had testified you were entertaining the possibility of leaving the hospital? A. I had said to my brother, Keith, quite frankly, get me some drugs or get me the hell out of here; there's a problem. I felt we were going on too long without pain medication, and the baby was in duress [sic] and all these other things. I wanted some action taken. * * * Q. I guess I'm leading up to the question. Did you feel even at that stage that you had options? A. Yes. Q. And what did those options include? A. Leaving -- you mean leaving the hospital? My options were to, you know, seek other medical advice or get a second opinion or do something, because I felt it was lagging. I felt that this was going terribly wrong. Q. Okay. Okay. Did the NICA pamphlet and the nurse's explanation give you some comfort? A. Yes. * * * Q. And that's not your signature on the . . . [receipt for the NICA pamphlet?] A. No. Q. And that signature, is that of your husband? A. Correct. Q. So this nurse comes in; you were in severe pain; you were in and out of it, as you said before, but you specifically remember the nurse coming in and describing this NICA pamphlet? A. Yes. Q. Now, do you recall where your husband signed this? Was this at the bedside, or did -- because earlier you testified that you told your husband, just take care of it, which I guess is one reason why his signature's on it. Did they step to the side and sign it, or did he sign it right there at the bedside with you? A. I believe what happened was he stepped to the side -- the nurse came over here in the corner. There was a sink on this side, if I remember correctly. * * * Q. . . . [Y]ou testified that Dr. St. John consulted with four other doctors -- A. Correct. Q. . . . Do you remember what that consultation was about? A. About natural delivery versus the C- section. Q. And it was those four doctors that agreed that you were to have a vaginal delivery; isn't that correct? A. That was my interpretation, yes. * * * Q. . . . so it's fair to say that you had a lot of faith and confidence in Dr. St. John? A. Yes. I trusted her. Q. And she advised you that a vaginal delivery was the best means to go; is that correct? A. Well, yeah. She told me that's what I was having. Q. So regardless of you ever seeing a NICA pamphlet, you followed Dr. St. John's orders on her advices; is that correct? A. Well, I was relying upon my doctor's final say. Q. Okay. Which was to have a vaginal delivery; is that correct? A. Correct. * * * Q. Earlier, you testified that the two times that you signed for the receipt of the NICA pamphlet, as we've been calling it, neither of those times you ever read the pamphlet; is that correct?[9] A. That's correct. Q. And you didn't read the pamphlet until, you would say, two weeks or a week after -- A. I would say the first week . . . . Also speaking to the estoppel issue was Mr. Joshnick, who testified at hearing, as follows: Q. This is the consent . . . and also . . . a receipt for the NICA form. Is that your signature? A. Yes, it is. Q. Okay. Why did you sign this document? A. Well, the nurse handed me the pamphlet of the NICA and gave a brief explanation for what it was, and I figured, well, I guess I should sign. * * * THE COURT: . . . When did you ultimately read the pamphlet? THE WITNESS: Actually, I really didn't read the pamphlet until quite a while later when I -- when we were realizing that things had gone wrong. THE COURT: You're talking about months later? THE WITNESS: I really don't even know how long [it] was. THE COURT: After Austin's discharge from the hospital? THE WITNESS: Yes. * * * Q. What do you recall the nurse -- Nurse Collins saying about the pamphlet, the NICA? A. Just saying that it was somewhat like an insurance policy. If things went wrong with delivery and all that we'd be covered to a certain degree. * * * Q. And when you signed for that, did you sign for that at the bedside or away from the bedside? A. At the bedside. Q. Were you given any other papers to sign? A. It's very possible. It's quite a while ago. I don't really recall. A lot of things were happening. Q. And did the nurse describe any of those other papers that you saw? A. I really don't recall anything on that, no. Q. So you recall the nurse discussing the NICA pamphlet but no other documentation; is that correct? A. Correct. Contrasted with Petitioners' testimony, Respondent offered the deposition testimony of Nurse Collins. Not unexpectantly, Nurse Collins did not recall the incident, but offered the following testimony regarding her normal practice: Q. . . . What was your normal business practice of saying to patients about the NICA pamphlet? A. I would hand them the form that needed to be signed, and I would tell them there were two places that needed to be signed. The first one, I would usually hand them the pamphlet and say -- customarily say, "Here is this pamphlet. You are signing that you received this pamphlet; not that you've read it, just that you've received it. And you need to sign here, and then you need to sign down at the bottom here for consent for these procedures," and I would read over those procedures with them. Q. Would you volunteer anything about the pamphlet? A. If I volunteered anything at all, it would only have been that if it was the neurological information -- well, what is it? --Neurological Injury Compensation Association, and that if somebody [sic] happened, you might have the possibility of being covered. * * * Q. In your normal practice, what is your understanding of the NICA pamphlet . . . [?] A. I didn't really -- I never read the pamphlet. But I guess my understanding was that if during the course of the birth of a baby there was some neurological accident or impairment, there might possibly be some compensation available to them. Finally, in the opinion of Dr. St. John, which stands uncontradicted, there was no medical justification to deliver Austin by cesarean section, and absent medical justification surgery would be contraindicated and against her ethical obligations. (Respondent's Exhibit 6, pages 21, 27 and 30). Here, the testimony and other proof offered on the issue of estoppel, predicated on Nurse Collins' remarks, have been carefully considered, and found less than compelling on some key issues. First, the proof failed to demonstrate, with the requisite degree of certainty, that Nurse Collins made an affirmative assurance, without limitation, as opposed to a general comment as to the nature of the program. In so concluding, it is noted that, given the passage of time and anxieties of the moment, it is unlikely either Mr. or Mrs. Joshnick would recall any comment Nurse Collins made regarding the NICA program, much less recall her remarks with any degree of accuracy, and that the remarks they attribute to her are so general, as not to reasonably support an assurance of coverage, without limitation. Moreover, given Mrs. Joshnick's condition on presentation to the hospital, and the events that ensued, it is evident that it was Dr. St. John's opinion that vaginal delivery, not cesarean delivery was medically appropriate, that Petitioners accepted that opinion, and that Petitioners did not rely in whole or in part on NICA coverage in deciding not to insist on a cesarean delivery. Finally, apart from Nurse Collins' comments, Petitioners contend that NICA should be estopped to deny coverage based on the NICA brochure. Pertinent to this claim, the brochure provided: Criteria and Coverage Birth-related neurological injuries have been defined as an injury to the spinal cord or brain of a live-born infant weighing at least 2500 grams at birth. In the case of multiple gestation, the live birth weight is 2000 grams for each infant. The injury must have been caused by oxygen deprivation or mechanical injury, which occurred in the course or labor, delivery or resuscitation in the immediate post delivery period in a hospital. Only hospital births are covered. The injury must have rendered the infant permanently and substantially mentally and physically impaired. The legislation does not apply to genetic or congenital abnormalities. Only injuries to infants delivered by participating physicians, as defined in s. 766.302(7), Florida Statutes, are covered by the Plan. * * * You are eligible for this protection if your doctor is a participating physician in the NICA Plan. If your doctor is a participating physician, that means that your doctor has purchased this benefit for you in the event that your child should suffer a birth-related neurological injury, which qualifies under the law. If your health care provider has provided you with a copy of this informational form, your health care provider is placing you on notice that one or more physician(s) at your health care provider participates in the NICA Plan. (Petitioners' Exhibit 3) According to Petitioners: A reasonable person would have concluded, "If [Morton Plant] has provided [Petitioners] with a copy of [the Pamphlet], . . . one or more physician(s) at [Morton Plant] participates in the NICA Plan." A fair reading of the Pamphlet as a whole, is that this participation of a Morton Plant physician--regardless of particular obstetricians' participation--was enough to give Petitioners NICA coverage. (Petitioners' Proposed Findings of Fact & Conclusions of Law, paragraph 20) However, a "fair reading" of the NICA pamphlet does not support Petitioners' interpretation. Rather, the brochure provides, unequivocally, that "[o]nly injuries to infants delivered by participating physicians, as defined in s. 766.302(7), Florida Statutes, are covered by the Plan." Moreover, Petitioners never read the pamphlet until well after Austin's birth and, therefore, could not have relied, detrimentally or otherwise, on its provisions.
The Issue The issue for determination at formal hearing was whether Respondent committed the offenses set forth in the administrative complaint, and, if so, what action should be taken.
Findings Of Fact The Department of Professional Regulation (now, the Agency for Health Care Administration), Board of Medicine (Petitioner), is the state agency charged with regulating the practice of medicine pursuant to Section 20.30, Florida Statutes, and Chapters 455 and 458, Florida Statutes. At all times material hereto, Arthur J. Schatz, M.D. (Respondent), has been a licensed physician in the State of Florida, having been issued license number ME 0024745. On or about September 7, 1988, Patient A. H., a 61-year-old female, presented to her internist with complaints of left pelvic pain. The internist ordered a pelvic sonogram and an MRI. Both procedures revealed a five centimeter mass on the left side of Patient A. H.'s pelvis. The internist referred Patient A. H. to Respondent. On or about September 16, 1988, she presented to Respondent who performed an examination by palpation, which revealed a mass on the left side of her pelvis. Respondent diagnosed Patient A. H. as having a left ovarian tumor. Respondent scheduled Patient A. H. for exploratory laparotomy and probable total abdominal hysterectomy and bilateral salpingo-oophorectomy. Exploratory laparotomy is a surgical procedure in which a patient's abdomen is opened to explore the abdominal cavity in order to determine whether there is any pathology present. Exploratory laparotomy was indicated, and Respondent was qualified and credentialed to perform the surgical procedure. Because of the location of the mass and because of Patient A. H.'s history, especially her age, pre-operatively, Respondent believed that the mass was highly suggestive of a malignancy. Respondent did not perform or order any other diagnostic test or seek any consultation with any other physician or any specialist. Such conduct by Respondent was within the acceptable standard of care, skill, and treatment in the practice of medicine. On or about September 25, 1988, Respondent admitted Patient A. H. to Parkway Regional Medical Center for the surgical procedure to be performed. On or about September 26, 1988, Respondent performed the exploratory laparotomy. Upon entering Patient A. H.'s abdomen, Respondent took washings. Respondent then proceeded to examine her female organs and discovered that they were normal. Continuing, Respondent palpated the mass on the left side of Patient A. H.'s pelvis in the retroperitoneal area, behind a very thin layer of tissue called the peritoneum. Pre-operatively, Respondent could not have known that the mass was retroperitoneal. The overwhelming majority, ninety-eight percent, of gynecologic surgery is performed on the intra-peritoneal structures, while only two percent is performed retroperitoneally. General gynecologists are trained to and do perform surgical procedures retroperitoneally. Respondent appropriately elected to open the peritoneum and entered the retroperitoneal space to identify and surgically address the area of suspected pathology. He found a somewhat soft mass, approximately five centimeters in diameter, on the pelvic side wall with a white structure running through the middle of the mass. The mass, a tumor, which was encapsulated was round in shape and yellowish in color. Encapsulation is more commonly associated with benign tumors than malignant tumors. Unsuccessfully, Respondent attempted several times to dissect the mass off the white structure. Respondent recognized the white structure as the obturator nerve which was later identified as such. Respondent observed that the mass had the general appearance of a lymphoma which is a benign, fatty, slow-growing tumor. However, he was unable to precisely identify the nature of the mass which could also have been lymphosarcoma, malignant, since no analysis had been performed on the mass. Respondent believed that the tumor was more likely benign than malignant. Confronted with a most unusual situation in that the tumor was in a very unusual location and the obturator nerve was within the mass itself, Respondent requested that the entire hospital be paged for a gynecologic oncologist. He was informed that neither of the two gynecologic oncologists on the hospital staff were in the hospital or scheduled to be in the hospital. Respondent's act of not having a gynecologic oncologist present or on call during the scheduled surgery was not practicing medicine below the acceptable standard of care, skill, and treatment. Respondent then requested the paging of a general surgeon. A board certified general surgeon responded and entered the operating suite where Respondent was operating on Patient A. H. The general surgeon did not scrub to assist Respondent but came into Respondent's operating suite and viewed the operating field. He advised Respondent that he had never seen a condition like that of Patient A. H. and could offer no suggestions. Getting no assistance from the general surgeon, Respondent requested that a neurosurgeon or orthopedist be called. A board certified orthopedist was in surgery in an adjacent operating suite. Respondent broke scrub, left his operating suite and entered the orthopedist's operating suite. He questioned the orthopedist regarding the function of the obturator nerve and the anticipated effect of sacrificing the nerve, if that were necessary, in order to remove the tumor in its entirety. The orthopedist advised Respondent that the obturator nerve was a major nerve which governs the muscles involved in the adduction of the thigh and affects the ability to walk. He further advised Respondent that sacrificing the nerve should result in only a minimal disability which could be adequately addressed with physical therapy. Generally, a general gynecologist, including Respondent, has a cursory understanding of the function of the obturator nerve. Arising from the lumbar section of the spinal column, the obturator nerve is a major nerve and is extremely important in allowing a person's legs to move to the midline for the purpose of walking. After being advised by the orthopedist, Respondent re-scrubbed and returned to his operating suite. He again attempted, without success, to dissect the tumor from the obturator nerve. Thereupon, Respondent decided that Patient A. H. would benefit from a complete resection of the tumor even though it would mean sacrificing the obturator nerve in order to remove the tumor in its entirety. He had no experience in the removal of lymphomas from nerves. Respondent appropriately decided against performing a frozen section on the tumor, prior to removal, because such a procedure might expose Patient A. H. to the risk of cancer cells being spread through the retroperitoneal space if the tumor was malignant. His action was within the acceptable standard of care, skill, and treatment in the practice of medicine. A frozen section is a procedure in the intraoperative period 2/ in which a surgeon attempts to remove a piece of a tumor or mass to send to a pathologist to determine whether the mass is malignant or benign. The procedure is important because it provides the surgeon with direction as to how to proceed in terms of treatment and care of a patient while the patient is under anesthesia and in the operating room. Furthermore, Respondent appropriately decided against removing only portions of the tumor, thereby leaving some of it behind, because such a procedure could result in the tumor re-growing, and possibly as a malignancy. His action was within the acceptable standard of care, skill, and treatment in the practice of medicine. Respondent removed the tumor in its entirety which included removing the portion of the obturator nerve to which the tumor was attached to and incorporated within the tumor. Respondent sent the specimen to the pathology lab for analysis which revealed that the tumor was a fatty, benign lymphoma and that the white structure incorporated within the tumor was nerve tissue. Prior to removing the tumor in its entirety, there was no acceptable method available to Respondent for him to definitively know that the tumor was benign. Respondent failed to record his contacts with the general surgeon and the orthopedic surgeon in his operative notes for the surgery but recorded the contacts in his discharge summary. It is customary and appropriate to record intra-operative consultations in an operative report. Neither the general surgeon nor the orthopedist considered their contact with Respondent as a consultation. Patient A. H.'s postoperative recovery was not as anticipated in that she suffered severe, instead of minimal, disability which has affected her ability to walk. She is unable to walk without the assistance of either a cane or a leg brace. No literature or authority exists which supports the sacrifice of the obturator nerve for a benign tumor or a tumor which appears to be benign. Patient A. H.'s condition was a rare case because of the location of the tumor and because the tumor was attached to the obturator nerve which was incorporated within the tumor. Neither the expert for Petitioner nor for Respondent had ever experienced, or heard or read of such a situation. Furthermore, because of Respondent's experience with Patient A. H. and her resulting condition, both experts have greater knowledge of the obturator nerve. Respondent's removal of the tumor in its entirety, including removing a portion of the obturator nerve, was within the acceptable standard of care, skill, and treatment in the practice of medicine.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Agency For Health Care Administration, Board of Medicine, enter a final order dismissing the administrative complaint. DONE AND ENTERED in Tallahassee, Leon County, Florida, this 2nd day of December 1994. ERROL H. POWELL Hearing Officer Division of Administrative Hearings The DeSoto Building 1230 Apalachee Parkway Tallahassee, Florida 32399-1550 (904) 488-9675 Filed with the Clerk of the Division of Administrative Hearings this 2nd day of December 1994.
