The Issue The issue is whether Respondent is guilty of performing wrong-site surgery or performing a procedure without the patient's consent and, if so, what penalty should be imposed.
Findings Of Fact At all material times, Respondent has been licensed as a physician in the state of Florida. His license number is ME 85786. Respondent is Board-certified in anesthesiology and pain management by the American Board of Anesthesiology. Respondent has not previously been disciplined by the Board of Medicine. Patient K. D. suffered a back injury in November 1998. Following a laminectomy, Patient K. D. continued to suffer from chronic low-back pain. She visited Respondent's pain management clinic for pain relief and has been quite satisfied with the treatment that she has received from Respondent. On February 14, 2003, one of Respondent's partners performed a right-side lumbar rhizotomy by pulsed radiofrequency. The purpose of this procedure is to relieve or eliminate pain in the lower back. When performed by pulsed radiofrequency, the rhizotomy would probably not have been successful if the patient still experiences pain two weeks after the procedure. Two weeks later, on February 28, Patient K. D. presented for a left-side lumbar rhizotomy, which Respondent was to perform. Immediately prior to the surgery on February 28, while Patient K. D. was in pre-op, Respondent performed a physical examination and observed that Patient K. D. indicated pain on the right side. In response to questioning, Patient K. D. confirmed that her right side was more painful than her left side. Respondent said that he would therefore perform a right-side lumbar rhizotomy. Patient K. D. did not disagree or object, but consented to the procedure--in the presence of two nurses, as well as Respondent. Immediately after their pre-op discussion, Patient K. D. was administered Versed, which produces an effect of amnesia. To some extent, this drug may cause some retrograde amnesia, so that Patient K. D. might not recall events immediately preceding the administration of the drug, such as her physical examination and conversation with Respondent in pre-op. Respondent performed a right-side lumbar rhizotomy without incident. However, immediately after the procedure, Patient K. D. said that she also suffered left-side pain and questioned why Respondent had performed the procedure on her right side. When Patient K. D. complained that transportation problems would make it hard for her to re-schedule a left-side procedure, Respondent performed a left-side procedure, on the same day, and he completed this procedure also without incident. Prior to the February 14 and 28 procedures, Patient K. D. signed consent forms. The consent form for the February 14 procedure identifies a right-side procedure, and the consent form (actually, there are two identical forms) for the February 28 procedure identifies a left-side procedure. The forms state: It has been explained to me that during the course of an operation, unforeseen conditions may be revealed that necessitate an extensive exchange or change of the original procedure or different procedures, and I therefore authorize and require my physician or surgeon . . . to perform such surgical procedures as are necessary and desirable in the exercise of his and/or their professional judgement. . . . Petitioner's expert witness opined that a change in location, even under the above-described circumstances, "should" have been documented on a consent form, but later conceded that this is not strictly necessary. On cross-examination, Petitioner's expert witness admitted that a patient may give informed consent verbally or by conduct. Petitioner's expert witness properly discredited Respondent's theory that he had some form of ongoing consent because the forms bore no expiration date. However, to the limited extent that Petitioner's expert witness implied a requirement for written informed consent, his opinion is unsupported by Florida law, as set forth below. In contrast to Petitioner's expert witness, Respondent's expert witness did not equivocate on the issue of the required form of informed consent. Relying largely on the testimony of Patient K. D., Respondent's expert witness testified that Respondent had obtained the informed consent of Patient K. D. to perform a second right-side procedure. Aside from the obvious advantages of a written informed consent, Respondent's expert witness convincingly testified that informed consent is a state of mind, not a signature on a piece of paper, and, by this standard, which is consistent with Florida law, as set forth below, Respondent had Patient K. D.'s informed consent to perform a second right-side procedure on February 28 and thus had been duly authorized to do so.
Recommendation It is RECOMMENDED that Petitioner dismiss the Administrative Complaint, as amended, against Respondent. DONE AND ENTERED this 21st day of November, 2005, 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 21st day of November, 2005. COPIES FURNISHED: Larry McPherson, Executive Director Board of Medicine Department of Health 4052 Bald Cypress Way Tallahassee, Florida 32399-1701 R. S. Power, Agency Clerk Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Timothy M. Cerio, General Counsel Department of Health 4052 Bald Cypress Way, Bin A02 Tallahassee, Florida 32399-1701 Irving Levine Assistant General Counsel Department of Health 4052 Bald Cypress Way, Bin C-65 Tallahassee, Florida 32399-3265 Dennis A. Vandenberg Peterson Bernard 1550 Southern Boulevard West Palm Beach, Florida 33406
The Issue Should Respondent Patricia Dee G. Stehpenson's license to practice medicine in the State of Florida be revoked, suspended or otherwise disciplined based on the allegations contained in the Administrative Complaint filed herein?
Findings Of Fact Upon consideration of the oral and documentary evidence adduced at the hearing, the following relevant findings of fact are made: At all times material to this proceeding, the Respondent was a licensed physician in the State of Florida, having been issued license number ME 0051453. The patient, a 73 year old female, presented to Respondent on July 11, 1991, with complaints of flashes of light over the past ten years which had increased over the past two years. The patient also complained of seeing halos around street lights at night. During this visit, Respondent diagnosed the patient as having 20/30 corrected vision in her right eye and 20/40 plus 2 corrected vision in her left eye, and that the patient had cataracts. However, Respondent did not recommend cataract surgery at this time. In January, 1992, the patient took the State of Florida driver's license test, including the eye test, and received her driver's license. However, the examiner notice that the patient was having trouble with the eye test and, although the examiner gave the patient her driver's license, the examiner suggested that the patient see an opthalmologist. At the time the patient received her driver's license in January, 1992, the patient was enjoying golf, bowling and driving. Although the patient did not immediately follow the driver's license examiner's advice concerning her eyes, the patient did visit with Respondent on May 8, 1992. At this visit, the patient advised the Respondent that the flashes and floaters had improved but that her vision was interfering with her golfing and driving. Again, Respondent did not recommend removal of the cataract. The patient's vision continued to interfere with her golfing and driving, notwithstanding the patient's testimony to the contrary which I do not find to be credible. The patient's next visit with Respondent was on October 16, 1992. At this visit, the patient advised Respondent that her vision had "lessened a lot" in the left eye. Visual acuity testing indicated corrected vision of 20/30 in the right eye and 20/40 plus 2 in the left eye. However, while the level of vision at which the patient was able to perceive letters (20/40 plus 2) did not change, the refraction (stronger glasses) required to achieve that level indicated more myopia, indicating that the cataract had progressed which supports the patient's complaint that her vision had "lessened a lot". Also at the October 16, 1992, visit, Respondent tested the patient's vision using brightness acuity testing (glare test) and measured the patient's vision as 20/70, with glare in the left eye. The glare test is a method whereby the doctor shines a light in the person's eye to determine the effect of glare on the person's vision. Although some ophthalmologists consider the glare test of no value, other ophthalmologists consider the glare test as another tool to assist the surgeon in making a decision concerning the necessity for cataract surgery. During the October 16, 1992, office visit, Respondent discussed with the patient: (a) the effect the cataract was having on the patient's activities (life-style); (b) the patient's complaint that her vision had lessened; (c) the results of the glare test showing the patient's vision as 20/70 with glare and; (d) other visual acuity testing; and (e)advised the patient that cataract surgery was indicated. Also, Respondent explained the cataract surgery procedures and discussed with the patient the risks and the benefits of the surgery. The patient had no reservations or objections to the surgery and consented to the surgery in hopes of improving her eyesight as well as her life- style. For a person with cataracts, a corrected vision of 20/40 or worse is the vision level where some cataract surgeons will recommend cataract surgery, while other cataract surgeons consider a corrected vision of 20/50 or worse, with or without glare, as the vision level where cataract surgery should be recommended. However, because the vision as determined by visual acuity testing (the ability of the person to perceive letters) does not always accurately reflect the person's quality of vision (the quality of perception on a day to day basis), neither vision level referred to above when considered alone can be used as a hard and fast rule to form a basis for cataract surgery. Since the quality of vision can only be described by the person with the cataract(s), the cataract surgeon must also determine, after consultation with the person, that the cataract(s) are interfering with the person's life-style. Therefore, a person with corrected vision of somewhat better than 20/40 or 20/70 with or without glare, may be a candidate for cataract surgery, provided the cataract is causing a reduction in the person's quality of vision beyond what is indicated by visual acuity testing and thereby interfering with the person's life-style. Furthermore, there are no written standards or guidelines which set a particular vision level for the cataract surgeon to follow when making a decision to recommend cataract surgery. The surgeon must take into consideration all factors and make a decision based on the surgeon's judgment as to what is best for that person. The patient's vision level and the interference the patient was experiencing with her life-style because of the cataracts in her left eye justified Respondent's decision to recommend and perform the cataract surgery on the patient, notwithstanding any of the testimony of Dr. Leslie Monroe to the contrary. On November 3, 1992, Respondent performed phacoemulsification (removal of cataract) with posterior chamber intracular lens implant (implantation of lens) on the patient's left eye. While the patient was in the holding area being prepared for surgery there were complications with the anesthesia. The anesthesiologist, Robert Dienes, M. D., first gave the patient a retrobulbar block which was repeated apparently due to Dr. Dienes' conclusion that the first retrobulbar block was ineffective. Apparently, Dr. Dienes also concluded that the second retrobulbar block was ineffective and gave the patient a superior lid peribulbar block. After giving the peribulbar block, Dr. Dienes noticed a dissecting subconjunctival hemorrhage and notified Respondent. Upon examining the patient's eye, Respondent found the globe (whole eye) to be soft with no active bleeding, indicating the eye was not full of blood and that there was no retina tear or rupture of the globe. Respondent also noticed that "the conjunctiva was real chemotic or it had blood behind it". Respondent also measured the patient's eye pressure with a Schiotz tonameter because there was no slit-lamp in the holding area. The patient's eye pressure was 5, with a 5.5 gram weight, which was normal. The patient's medical records do not reflect an indirect ophthalmoscopy being performed by Respondent on the patient's left eye between Respondent being advised of the dissecting subjunctival hemorrhage by Dr. Diemes and the Respondent performing surgery on the patient's left eye to remove the cataract and implant the lens. Furthermore, Respondent has no independent recollection of performing an indirect ophthalmoscopy during the above period of time before surgery. Respondent's normal practice under conditions and circumstances similar to those in this case has been to perform an indirect ophthalmoscopy during the above period of time before surgery. Therefore, it is assumed that Respondent performed an indirect ophthalmoscopy on the patient after being advised of the subconjunctival hemorrhage but before surgery, notwithstanding the fact that patient's medical records do not reflect such procedure being performed or the fact that Respondent has no independent recollection of performing such procedure during the above period of time. However, assuming arguendo that Respondent did not perform the indirect ophthalmoscopy before surgery, the Agency has failed to establish facts to show that under the conditions and circumstances of this case that such failure amounted to the failure of Respondent to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances. After considering the conditions and circumstances surrounding the complication that arose while the patient was being anesthetized, Respondent made a decision that it was in the best interest of the patient to go forward with the removal of the cataract and implantation of the lens. The operation was completed without any further incident and there was a successful removal of the cataract and lens transplant. Respondent's decision to go forward with the surgery had no adverse effect on the subsequent treatment of the complication that arose while the patient was being anesthetized. In fact, the result of the treatment subsequent to the cataract surgery would have been the same even if Respondent had not gone forward with the surgery. Respondent, using a ophthalmoscope, was able to see the inside of the eye more clearly and assess the complication that arose while the patient was being anesthetized. While performing this indirect ophthalmoscopy, Respondent noted undulation of the vitreous with pigmented blood cells present and that the anesthesia needle had penetrated the globe. The patient was seen the next morning, November 3, 1992, by Respondent. After assessing the condition of the patient's left eye, Respondent referred the patient to Keye Wong, M. D., a retina specialist. Upon examining the patient's left eye on November 4, 1992, Dr. Wong noted vitreous hemorrhaging and retinal detachment. Dr. Wong performed an operation on the patient's left eye in an attempt to correct the damage and attach the retina. The patient's vision is not as good as it was before the operation, and still effects the patient's life-style. The patient has difficulty tolerating sunlight, which may or may not be a result of the complication experienced while the patient was being anesthetize. Respondent's action of going forward with the surgery after becoming aware of the complication that arose while the patient was being anesthetized did not cause, complicate, aggravate or result in any of the problems the patient has suffered postoperatively. Respondent did not fail to recognize, identify or treat properly the complications that arose before, during or after the surgery. The Agency has failed to establish facts to show that Respondent failed to practice medicine with that level of care, skill, and treatment which is recognized by a reasonably prudent similar physician as being acceptable under similar conditions and circumstances at anytime while Respondent was treating the patient, including both preoperative and postoperative treatment.
Recommendation Based upon the foregoing Findings of Fact and Conclusions of Law, it is recommended that the Petitioner Agency for Health Care Administration enter a final order dismissing the Administrative Complaint filed herein against Respondent Patricia Dee G. Stephenson, M. D. DONE and ENTERED this 23rd day of January, 1996, at Tallahassee, Florida. WILLIAM R. CAVE, 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 23rd day of January, 1996. APPENDIX TO RECOMMENDED ORDER, CASE NO. 95-1560 The following constitutes my specific rulings, pursuant to Section 120.59(2), Florida Statutes, on all of the proposed findings of fact submitted by the Petitioner and the Department in this case. Agency's Proposed Findings of Fact. Proposed findings of fact 1-2 are adopted in substance as modified in Findings of Fact 1 and 2. The first sentence of proposed finding of fact 3 is adopted in Finding of Fact 3. The second and third sentence are not supported by evidence in the record. Proposed finding of fact 4 is adopted in substance as modified in Finding of Fact 5, otherwise not supported by evidence in the record. Proposed finding of fact 5 is adopted in substance as modified in Finding of Fact 7, otherwise not supported by evidence in the record. Proposed finding of fact 6 is adopted in substance as modified in Findings of Fact 12, 13, and 14, otherwise not supported by evidence in the record. Proposed findings of fact 7 and 8 are adopted in substance as modified in Findings of Fact 21 and 22, otherwise not supported by evidence in the record. Proposed finding of fact 9 is a restatement of Dr. Monroe's testimony and is not a finding of fact. However, see Findings of Fact 16 and 17. 8, Proposed findings of fact 10, 16, 17 and 19 are adopted in substance as modified in Findings of Fact 15, 16, 10, 8 and 9. Proposed finding of fact 11 is adopted in substance as modified in Finding of Fact 16, otherwise not supported by evidence in the record. Although proposed findings of fact 12, 13 and 15 are findings of fact, they are neither material nor relevant to this proceeding. See Finding of Fact 9. Proposed finding of fact 14 is a restatement of Dr. Grabow's testimony and is not stated as a finding of fact, but see Finding of Fact 10. Dr. Grabow's testimony was 20/50 vision with or without glare which is different than just 20/50 vision. 11. Proposed findings of Fact 18 and 20 are not supported by evidence in the record. Respondent's Proposed Findings of Fact. 1. Proposed findings of fact 1 through 27 are adopted in substance as modified in Findings of Fact 1 through 25. COPIES FURNISHED: Marm Harris, M. D., Executive Director Board of Medicine Northwood Centre 1940 North Monroe Street Tallahassee, Florida 32399-0770 Jerome W. Hoffman, Esquire Agency for Health Care Administration Fort Knox Building Number Three 2727 Mahan Drive Tallahassee, Florida 32308 Steve Rothenburg, Esquire Agency for Health Care Administration 9325 Bay Plaza Boulevard, Suite 210 Tampa, Florida 33619 William E. Partridge, Esquire Lutz, Webb, Partridge, BoBo, and Baitty One Sarasota Tower 2 North Tamiami Trail, Suite 500 Sarasota, Florida 34236
Findings Of Fact Dr. Gans is a chiropractor licensed in Florida on the basis of examination. Dr. Gans prepared and filed an application for examination and licensure with the Florida State Board of Chiropractic Examiners. Dr. Gans answered the question on the application, "Do you have a chiropractic license in any state?" by stating: "Ohio - Mechanotherapy." The Ohio authorities recognized several professions whose functions would be included under the practice of chiropractic in Florida. Mechanotherapy generally would be limited to the practice of manipulation only. Dr. Gans was licensed in Ohio as a mechanotherapist. Dr. Gans answered the question on the application, "Have you ever been refused licensure in any state?" by stating, "No." Dr. Gans had applied for, taken, and failed the Ohio chiropractic examination whereupon he was not issued a license as a chiropractor by the State of Ohio. Dr. Gans was eligible to reapply to take the Ohio examination. At the time of his application to Florida, Dr. Gans had appealed the determination by the Ohio authorities that he had failed the Ohio examination.
Recommendation Based upon the foregoing findings of fact and conclusions of law, the Hearing Officer recommends that the Florida State Board of Chiropractic Examiners revoke the license of Ray E. Gans. DONE AND ORDERED this 2nd day of October, 1978 in Tallahassee, Florida. STEPHEN F. DEAN Hearing Officer Division of Administrative Hearings 530 Carlton Building Tallahassee, Florida 32304 (904) 488-9675 COPIES FURNISHED: John R. Sutton, Esquire 250 Bird Road, Suite 310 Coral Gables, Florida 33146 Paul Lambert, Esquire 1311 Executive Center Drive Tallahassee, Florida 32301 C. A. Hartley, Director Florida State Board of Chiropractic Examiners Suite 202, Building B 6501 Arlington Expressway Jacksonville, Florida 32211
The Issue The issues to be determined are whether Respondent violated section 478.52(1)(m), Florida Statutes (2017),1/ by accepting and performing professional responsibilities that she knew or had reason to know she was not competent to perform; and, if so, what penalty should be imposed for the violations proven.
Findings Of Fact The Department is the state agency charged with the licensing and regulation of electrolysis pursuant to section 20.43 and chapters 456 and 458, Florida Statutes. At all times material to the Administrative Complaint, Respondent has been licensed as an electrologist in the State of Florida, having been issued license number EO2650. Respondent is also licensed by the State of Florida as an acupuncturist, license number AP 1378. Respondent is a certified surgical assistant, having obtained certification through the American Board of Surgical Assistants. Documents in the record indicate that in 1998, Respondent completed medical school at Universidad Libre in Barranquilla, Columbia. However, Respondent is not a licensed medical doctor in the State of Florida. Respondent’s address of record is 8210 West Waters Avenue, Tampa, Florida 33615. At all times material to the Administrative Complaint, Respondent owned and operated Orozco Medical Center (“OMC”), located at 8210 West Waters Avenue, Tampa, Florida 33615. Patient N.M. Patient N.M. is a female born in 1964. She testified that she was familiar with OMC because she had therapy there following a car accident in 2000. N.M. presented to OMC in early 2015 for consultation regarding a liposuction with fat transfer procedure, commonly called a “Brazilian Butt Lift” (“BBL”). Fat is taken from one part of the body and reinjected into the buttocks. N.M. testified that Blanca Cabrera, who performs massages at OMC, recommended a “doctor” at OMC named Marlon Barcelo to perform her BBL. Marlon Barcelo worked at OMC as a surgical assistant but was not a medical doctor. N.M. testified that she believed Mr. Barcelo would perform her BBL procedure and that she never knew that he was not a physician. Ms. Cabrera told her that Mr. Barcelo had been a very good doctor in Columbia. N.M. testified that at her initial consultation at OMC regarding the BBL, she met exclusively with Respondent, who showed her where the fat would be removed and where it would be injected. N.M. testified that she met with Respondent three times before her surgery. N.M. testified that, at the conclusion of the initial consultation, she was given an appointment card directing her to return to OMC on January 13, 2015, for an electrocardiogram, lab work, and the medication she would be expected to take before the procedure. The medical records indicate that N.M. was confused as to the dates. It appears from the records that her initial consultation was on January 13, 2015, that her EKG and lab work were performed on March 2, 2015, and the date of her surgery was March 13, 2015. N.M. testified that each time she visited OMC prior to the surgery, she met only with Respondent, who examined her and explained the procedure to her with no other persons present. N.M. testified that on the date of the surgery, her daughter drove her to OMC. After she checked in at the front desk, N.M. was taken to an exam room and told to change into a hospital gown. Respondent then marked her body to identify the locations where fat was to be removed. Respondent gave N.M. a medication to calm her prior to the procedure. The medical record indicates that N.M.’s pre- operative medications included Keflex (cephalexin, an antibiotic), lorazepam (a sedative and anti-anxiety medication), and Benadryl (diphenhydramine, an antihistamine with sedative properties). N.M. described the medication’s effect as “like a Xanax.” N.M. testified that the medication relaxed her but did not affect her recollection of the procedure. She testified that she was awake throughout the surgery and was allowed to use her cell phone during the procedure. N.M. did not recall meeting Dr. Mark Kantzler and denied ever meeting Dr. Amina Edathodu. She believed that Mr. Barcelo was going to perform the surgery, though up until the morning of the procedure she had not met him. N.M. was taken to the surgical room and placed on a table. She stated that there was a drape that blocked her view of the surgical area, but that it was low enough to allow her to see everyone in the room. She could see two men, Mr. Barcelo and someone identified as “Abel,” and Ms. Cabrera, the massage therapist, who appeared to be assisting. N.M. testified that Mr. Barcelo performed the liposuction. She testified that everyone in the room was wearing surgical gowns and gloves but no surgical masks. N.M. testified that during the liposuction procedure, Respondent told her that she would be performing the fat injections because she was very good at that procedure. N.M. testified that after the liposuction was completed, Mr. Barcelo called on Respondent to perform the fat injections into her buttocks. N.M. stated that she saw Respondent walk into the room carrying a syringe. During this portion of the procedure N.M was positioned on her stomach but stated that she knew from the conversation in the room that it was Respondent who was placing the injections into her buttocks. Upon conclusion of the procedure, Respondent gave N.M. pain medication for post-surgical pain. N.M. returned to OMC for a follow-up visit regarding the lack of drainage from her incision. During this visit, Respondent examined N.M. and gave her medication to reduce the swelling she was experiencing. Dr. Edathodu testified that she has been a licensed physician in the State of Florida for over 25 years. From 2015 through 2017, she worked as a contract physician at OMC and acted as medical director for the facility. Dr. Edathodu developed the protocols for OMC’s tumescent liposuction procedures and ensured they were followed. Dr. Edathodu remembered N.M. as a patient who had undergone previous surgeries and presented for further liposuction and fat transfer. Dr. Edathodu testified that she performed the liposuction procedure on N.M. Dr. Edathodu’s signature is on the cosmetic surgery consent form that was also signed by N.M. on March 3, 2015. The “Liposuction and Autologous Fat Transfer” consent form signed by N.M. on March 3, 2015, specifically names Dr. Edathodu as the surgeon who will perform the procedure and was signed by Dr. Edathodu. Dr. Edathodu testified that she reviewed the procedure with N.M., discussing the risks and benefits. Dr. Edathodu does not speak Spanish and uses Respondent to translate with Spanish speakers such as N.M. She identified herself to N.M. as a surgeon through Respondent’s translation. Dr. Edathodu spoke to N.M. about having realistic expectations and cautioned her that she may not obtain an optimal result because of her previous procedures. Dr. Edathodu testified that, aside from her, the persons in the surgical theater were three surgical assistants: Respondent, Mr. Barcelo, and Pavel Cabanes. It is found that Mr. Cabanes must have been the “Abel” referred to by N.M. Dr. Edathodu testified that during the surgery, there is a drape between the surgical field and the patient’s face and head, to prevent the patient from being disturbed by the sight of the procedure. The drape is made of disposable paper and is about five feet high. When performing the surgery, Dr. Edathodu is unable to see the patient’s face and the patient is unable to see past the drape. Dr. Edathodu testified that she performed the entire surgical procedure on N.M. Dr. Edathodu made the site markings on N.M. while Respondent took photographs. Respondent did not perform any part of the surgical procedure. Respondent performed none of the fat transfer on N.M. Respondent did nothing other than what Dr. Edathodu specifically directed her to do. Dr. Edathodu testified that she met with N.M. on four or five occasions after the surgery. Dr. Edathodu’s testimony, as supported by the medical records, is credited. Perhaps because of her inability to speak English, N.M. appeared confused and inconsistent in her testimony, at least as it appeared in the Transcript. N.M.’s credibility was strained by her uncertainty as to dates and medications. She offered improbable details, such as the lack of coverage by the surgical drape and the failure of the surgical team to wear masks. N.M. was certain that Respondent was performing the fat injection, even though N.M. could not see what was happening. Though N.M. testified that she was awake and alert during the procedure, the undersigned cannot disregard that she had been given a medication that she likened to Xanax, most likely the lorazepam. The undersigned hesitates to rely upon N.M.’s disjointed testimony where it conflicts with the straightforward and credible testimony of Dr. Edathodu.3/ Based on the foregoing findings of fact, it is found that the Department has failed to establish by clear and convincing evidence that Respondent performed an invasive/surgical medical procedure on Patient N.M. Patient R.C. Patient R.C. is a female born in 1988. At the time of the hearing, she worked as a claims specialist. She testified that a friend from her previous job at HealthPlan Services referred her to OMC for a consultation. She first went to OMC on or about June 6, 2016. R.C. testified that this initial consultation was with Respondent. She told Respondent that she wanted liposuction on her back and waist and wanted the fat transferred to her buttocks. They discussed the procedure and pricing. From that point until the day of the surgery, R.C. went to OMC only to drop off periodic payments for the surgery. Her only contact was with the person at the front desk. She testified that she did not see Respondent again until the day of her surgery. R.C.’s surgery was scheduled for August 5, 2016. R.C. testified that she was dropped off at OMC by her children’s father. She went in and met Respondent and a few workers in the front of the facility. When she went to the back to prepare for the procedure, she met a man wearing scrubs whom she had never seen before. Two other staff persons were present, but R.C. stated she only talked with the one staff person who spoke English. R.C. testified that Respondent and the man in scrubs marked her body for the surgery. She believed that Respondent was going to perform the surgery. R.C. stated that she was not familiar with Dr. Edathodu. R.C. stated that she filled out the consent forms on August 5, 2016. An assistant gave her medication, saying it would calm her down. R.C. was not told the name of the medication, but testified that she took a blue pill and half of a white pill. The medical records indicate she was given Ativan (a brand name for lorazepam) and Benadryl. R.C. testified that the medications made her drowsy. R.C. was assisted to the room where the surgery would be performed. R.C. testified that she was placed on her stomach, face down. Everyone in the room was wearing a surgical mask. In the room were Respondent, the man in the scrubs, and two assistants. R.C. stated that she was awake during the procedure, but was drowsy and did not recall much about it. She could hear Respondent’s voice and the noise of the liposuction machine. She could not see who actually performed the procedure. After it was over, one of the assistants phoned R.C.’s driver and helped R.C. get up and walk. Respondent handed her a bag containing pills that R.C. believed were antibiotics. She received post-operative instructions. R.C. testified that she returned to OMC for a follow- up visit about a month after the surgery and met with Respondent. Dr. Edathodu testified that she performed the surgical procedure, called “tumescent liposuction,” on R.C. on August 5, 2016. On August 2, 2016, R.C. signed a “liposuction & autologous fat transfer consent” form that specifically named Dr. Edathodu as the surgeon who would perform the surgery. Dr. Edathodu ordered, reviewed, and signed R.C.’s lab results. Dr. Edathodu met with R.C. prior to the procedure and completed a “pre-operative clearance” form to document R.C.’s fitness and willingness to go through the surgery. Both R.C. and Dr. Edathodu signed the pre-operative clearance form. Dr. Edathodu testified that she met with R.C. three or four times post-surgery. As in the case of N.M., all of the medical records support the version of events described by Dr. Edathodu.4/ Dr. Edathodu’s testimony, as supported by the medical records, is credited. R.C. frankly conceded that she did not remember much about the surgery and could not see who performed it. Dr. Edathodu clearly and credibly recalled performing the procedure. The greater weight of evidence supports the finding that Dr. Edathodu performed the surgery, assisted by Respondent and Mr. Barcelo. The evidence could not sustain a finding that Respondent performed a surgical procedure on R.C. R.C. was a more credible witness than N.M., and her testimony on some of the details regarding her consultations and pre-operative events was persuasive. However, it must be kept in mind that the only relevant factual question is whether Respondent performed an “invasive/surgical medical procedure” on R.C. The evidence on this question is not persuasive. Based on the foregoing findings of fact, it is found that the Department has failed to establish by clear and convincing evidence that Respondent performed an invasive/surgical medical procedure on Patient R.C. Patient K.H. Patient K.H. is a female born in 1989. She learned of OMC from a friend at work. She first came into OMC for a consultation regarding a liposuction and fat transfer on November 29, 2016. K.H. testified that she met only with Respondent at this initial consultation. On November 29, 2016, K.H. signed an “information certification” form accepting Dr. Mark Kantzler as the physician who would be in charge of her liposuction procedure. K.H. came back to OMC on January 9, 2017, to make a $500 deposit and to schedule the surgery. The procedure was scheduled for February 11, 2017. Again, K.H. testified that she met alone with Respondent, who told her that she would need to come in a couple of days before the surgery to get medication and a list of things she would need for post-operative care. K.H. testified that she believed that Respondent was a physician and that she would be performing the liposuction procedure. The “liposuction and autologous fat transfer consent” form that K.H. signed on February 9, 2017, authorized Dr. Kantzler to perform the liposuction and fat transfer procedure. The “surgery certification” form that K.H. signed on February 9, 2017, indicated that Dr. Kantzler reviewed the entire medical file with her before performing the procedure. On February 11, 2017, K.H. was driven to OMC by her mother. Shortly after arriving, K.H. noted the presence of a tall man with white hair and blue eyes. An OMC assistant escorted K.H. to a room with a bed and a chair. Respondent came in to the room and marked K.H. for surgery. Respondent then called in the tall man with white hair and blue eyes, who looked at the surgical markings and then asked K.H. some questions about her stretch marks. During her direct examination, K.H. testified that she was not given the man’s name. During cross-examination, K.H. was forced to concede that during an August 2017 interview, she told Department investigators that she had been introduced to the tall man with white hair and blue eyes and that his name was Dr. Mark Kantzler. K.H. testified that Respondent gave her a pill to take before surgery. She was taken to the surgical suite and was placed on the table. K.H. testified that the surgical drape prevented her from seeing the surgical area. The only people she had noted in the room were Respondent and “Claudia,” a woman K.H. recognized as a massage therapist at OMC. She could not be certain whether or not Dr. Kantzler was in the room. K.H. testified that she was awake during the surgery. She stated that she was in pain during the surgery and complained, in Spanish, to Respondent. K.H. stated that Respondent told her she had “a little stubborn fat” and continued the procedure without doing anything to alleviate her pain. K.H. testified that all conversation during the procedure was in Spanish. She heard no English being spoken. K.H. confirmed that Dr. Kantzler was the physician who signed the letter requesting that she be excused from work immediately after her surgery. Dr. Kantzler testified that he had no specific recollection of K.H. or of her procedure. He stated that he worked on a contract basis with OMC for about three years. He came in about once a week to perform liposuction procedures, conforming to the protocols established by Dr. Edathodu. He saw the patients only briefly before their procedures, relying on Respondent to perform the patient consultations and Dr. Edathodu to prescribe the pre-operative tests in her role as medical director. He was paid by the procedure. Dr. Kantzler testified that he does not speak Spanish, but that his surgical assistants, Respondent and Mr. Barcelo, would often converse in Spanish during surgery. Dr. Kantzler reviewed the medical records and confirmed that he signed the documents and performed the surgery on K.H.: Q. Is there any doubt in your mind about whether or not you performed these procedures? A. Not when I’m looking at the files, no. Q. And if you had not done the procedures, would you have signed off on the documentation? A. I wouldn’t have had them to sign. No. Dr. Kantzler’s lack of a clear recollection distinguishes this procedure from those involving Dr. Edathodu. However, an offsetting distinguishing factor is that K.H. had a clear recollection of seeing and speaking with Dr. Kantzler at OMC on the morning of her surgery. She did not see him enter the surgical suite or hear him speak during the procedure, but she was unable to say that he was not in the room. The medical record is replete with indications that Dr. Kantzler performed the liposuction and fat transfer procedure on K.H. Dr. Kantzler testified that he voluntarily relinquished his Florida medical license in 2017 “for my own reasons not relevant to this [case].” The Department’s Proposed Recommended Order suggests that this relinquishment was “in response to or in anticipation of disciplinary proceedings.” There is no record evidence to support the Department’s suggestion, and it is disregarded here. Based on the foregoing findings of fact, the Department has failed to establish by clear and convincing evidence that Respondent performed an invasive/surgical medical procedure on Patient K.H.
Recommendation Based on the foregoing Findings of Fact and Conclusions of Law, it is RECOMMENDED that the Department of Health enter a final order dismissing Count I of the Administrative Complaint against Respondent, Claudia Patricia Orozco-Fandino, E.O. DONE AND ENTERED this 18th day of April, 2019, in Tallahassee, Leon County, Florida. S LAWRENCE P. STEVENSON 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 18th day of April, 2019.
