ALJDEC decisions subject to certification as final

15A-27016-MDX · Arizona Medical Board · 2016-01-20

IN THE OFFICE OF ADMINISTRATIVE HEARINGS

HEARING: July 13, 14, 16, and 17, 2015 APPEARANCES: Frederick M. Cummings, Esq. and Marki A. Stewart, Esq. for Respondent; Anne Froedge, Esq. for the Arizona Medical Board ADMINISTRATIVE LAW JUDGE: Thomas Shedden _____________________________________________________________________

On January 29, 2011 and again on March 22, 2011, Edgardo D. Zavala- Alarcon, M.D. performed liposuction on patient “HC” at Ciao Bella Medical Spa and Vein Clinic. Ciao Bella is an accredited ambulatory surgical center founded by Dr. Zavala. HC died on March 24, 2011. The autopsy report shows that HC died of anoxic encephalopathy following resuscitation from cardiac arrest following liposuction of the back and arms for morbid obesity and that the manner was “natural.” The Arizona Medical Board alleges that Dr. Zavala committed acts of unprofessional conduct and violated standards of care by performing the procedure on a patient for which it was contraindicated, performing the procedure in an outpatient setting, by failing to have the patient undergo a preoperative evaluation by an appropriate specialist, by failing to provide appropriate post-operative care, and by failing to maintain adequate records. The Board has not shown by clear and convincing evidence that the alleged violations occurred.

FINDINGS OF FACT 1. On January 22, 2015, the Board issued a Notice of Hearing setting the above-captioned matter for hearing beginning on February 26, 2015, at the Office of Administrative Hearings in Phoenix, Arizona. 2. The matter was continued and the hearing was conducted on July 13, 14, 16, and 17, 2015. 3. Dr. Zavala holds license #27016 issued by the Board. 4. As discussed in more detail below, Dr. Zavala is a cosmetic surgeon whose initial training and experience is in cardiology and internal medicine. Dr. Zavala originally practiced in Mexico; in 1998 he was licensed in Arizona where he eventually became Director of Cardiology at Maricopa Medical Center and at Phoenix Memorial Hospital. 5. Dr. Zavala planned to perform three sessions of large volume liposuction on HC using the super wet tumescent technique while she was under conscious sedation. Large volume liposuction is generally considered to be a procedure in which more than 5000 cc of fat is removed. 6. The procedure was scheduled for three sessions because Dr. Zavala wanted to limit the lidocaine exposure and because he would not remove more than 5000 cc in one session. According to Dr. Zavala, there is no scientific literature related to the 5000 cc per session limit, but it is an accepted value in the community. 7. In tumescent liposuction, saline with lidocaine and epinephrine is infused into the area of treatment and then suctioned out with the fat. Benefits of the tumescent method include reduced pain and reduced (or insignificant) blood loss. 8. In the super wet tumescent technique, the ratio of fluid infused to fat removed is reduced from a ratio of about three-to-one to one-to-one. 9. After a liposuction procedure, the holes that have been created are not sealed and they weep or leak the tumescent fluid that is always tinged with blood. This fluid is serosanguinous with about 1% blood. Liters of fluid are typically leaked and the leakage can continue for several days so the patient should be prepared to deal with it at home after discharge from the facility. 10. About 70% of the tumescent fluid will end up in the vascular system and a potential complication of tumescent liposuction is pulmonary edema due to this influx of fluid. This is why IV fluids are not required when tumescent liposuction is completed with good technique; the injudicious use of IV fluids is one of the main risks of tumescent liposuction. 11. Dr. Zavala added however that because the patients are typically a bit dehydrated on arrival, fluids are given at 50 to 60 cc per hour throughout the procedure and maintenance fluids are given during recovery. Patients are monitored and increased fluids are given only if necessary. 12. Dr. Zavala testified on his own behalf and presented the testimony of Michael Desvigne, M.D., a plastic surgeon who now works with Dr. Zavala; Jennifer Magnuson, RN; and Melvin Shiffman, M.D., a cosmetic surgeon. 13. The Board presented the testimony of investigator Anita Shepherd; Michael Murray, M.D., Ph.D., an anesthesiologist and internist; and Michael L. Brownstein, M.D., a plastic surgeon. 14. In addition, the Board had entered into evidence Medical Consultant Reports and Summaries and Supplemental Reports prepared by Daniel M. Caruso, M.D., a vascular surgeon, and Richard Fisher, M.D., a cosmetic surgeon, but the Board did not present testimony from either one. The Complaint and the Board’s Investigation 15. On April 16, 2013, HC’s husband, MC filed with the Board a Complaint against Dr. Zavala. The Board initiated this matter as case number MD-13-0426A. 16. MC’s Complaint includes what he purports is an account of the events of March 22, 2011, including statements MC attributes to Dr. Zavala. 17. Many of the allegations in MC’s Complaint were disproven at hearing (e.g., that Dr. Zavala administered a rousing agent to HC and that Dr. Zavala’s staff could not obtain blood pressure readings) and Dr. Zavala provided credible evidence showing that he had not made all the statements MC attributed to him.[1] 18. MC’s Complaint does not have sufficient indicia of reliability to be accorded appreciable weight in the absence of corroborating evidence. 19. After receiving MC’s Complaint, at the Board requested that Dr. Fisher review the matter. Richard Fisher, M.D. 20. Dr. Fisher prepared a Medical Consultant Report and Summary dated July 10, 2013, in which he concluded that “a careful examination” of the medical records failed to reveal any deviations from the standard of care for providing liposuction or post-operative care. 21. Dr. Fisher found that the standard of care for liposuction requires: a thorough initial consultation, preoperative history and physical, appropriate laboratory evaluation, careful review of informed consent, appropriate pictures, written pre- and post- operative instructions and prescriptions given to the patient. Dr. Zavala met all of these, he had the proper technique, and he provided the proper post-operative care. In addition, the procedure must be performed in an adequately designed surgical suite with proper resuscitative equipment, and appropriate operating room staff in attendance. Dr. Zavala also met this requirement. 22. Dr. Fisher concluded that HC was carefully monitored during her recovery, with appropriate testing completed. Dr. Fisher was of the opinion that HC’s blood pressure readings showed a definite and persistent trend, but no life threatening readings were recorded.[2] 23. Although the records show that the criteria for a “safe discharge home were apparently met,” Dr. Fisher was of the opinion that there must have been a problem given the length of time HC was in recovery and he raised questions related to Dr. Zavala’s decision to discharge HC to her husband’s care. It appears however that Dr. Fisher may have been relying on statements from HC’s husband (MC) that were disproven at the hearing. 24. After reviewing Dr. Zavala’s Response dated August 8, 2013, Dr. Fisher produced a second report in which he concluded that Dr. Zavala’s decision related to HC’s discharge was reasonable and that his actions had not deviated from the standard of care. In reaching this conclusion, Dr. Fisher considered the testing and monitoring that occurred during HC’s time in recovery and that HC was stable on discharge. Dr. Fisher then concluded that Dr. Zavala’s actions did not deviate from the standard of care. 25. The Board’s Staff Investigational Review Committee recommended that the matter be dismissed. The Board however voted to return the case for further investigation, including a review by a plastic surgeon and an internist. 26. Dr. Caruso reviewed the matter and prepared a Medical Consultant Report and Summary dated March 1, 2014 and a Supplemental Report dated June 14, 2014. 27. Dr. Brownstein reviewed the matter and prepared a Medical Consultant Report and Summary dated April 18, 2014 and a Supplemental Report dated May 27, 2014. 28. Dr. Murray reviewed the matter and prepared a Medical Consultant Report and Summary dated May 12, 2014 and a Supplemental Report dated June 6, 2014 29. None of the Board’s experts were provided the autopsy report prior to preparing their Medical Consultant Reports or Supplemental Reports. Daniel M. Caruso, M.D. 30. Dr. Caruso is an internal medical consultant for the Board, who is board-certified in surgery with special qualifications in surgical critical care. As of the hearing dates he was the Executive Chairman of the Department of Surgery at the University of Arizona, College of Medicine in Phoenix, and the Chairman of the Department of Surgery at Maricopa Medical Center. 31. In his March 1, 2014 Report, in “Section 2. Proposed Standard(s) of Care,” Dr. Caruso wrote: “Standard of care also mandates that adequate post-recovery care is provided to include adequate documentation, monitoring and clinical interventions that are determined by changes in the physiological measurements…. Once clinical interventions are performed, further evaluation and subsequent follow-up is then required. As noted previously, this reviewer feels these standards were not met.” 32. In his March 1, 2014 Report, in “Section 3. Deviations from the Standard of Care,” Dr. Caruso wrote: “… Dr. Zavala fell below the standard of care in terms of: 1) Intra-operative documentation and post-operative/recovery documentation. … 2) the patient is discharged to home (i.e. hotel) when [Dr. Zavala] himself, recommends that [HC] not go home but “stay close” due to [HC’s] extended recovery time and demonstrated hypotension post-operatively….” 33. In Section 3, Dr. Caruso also wrote that he did not agree (with Dr. Fisher) that HC was closely monitored, because even with the testing that was conducted, “the lack of clinical documentation of [HC’s] overall status in addition to no documentation of interventions for HC’s sustained relative or defined hypotension are very worrisome and frankly fall below standard of care.”[3] 34. In his March 1, 2014 Report, in “Section 8. Consultant’s Summary,” Dr. Caruso wrote: “This reviewer differs with the previous reviewer of this case finding substandard documentation as well as substandard post-operative care.” 35. Other experts do not agree that HC experienced hypotension during her recovery on March 22, 2011, and it was not proven at the hearing that she did. Because many of Dr. Caruso’s initial conclusions and opinions[4] are based on his opinion that HC did experience hypotension, these opinions are of limited evidentiary value. 36. Dr. Caruso’s March 1, 2014, Report also contains factual errors or misunderstandings that further limit the weight of the opinions in that Report. For example: a. Dr. Caruso wrote: “Upon discharge [MC was] told by Dr. Zavala it would be best if he did not drive[ HC] back to Sedona.” The evidence at hearing showed however that throughout HC’s second recovery, Dr. Zavala had been trying to convince MC not to return to Sedona and that MC’s instance on doing so increased the time HC spent in recovery. b. In the “Deviations from Standard of Care” section, Dr. Caruso relies on MC’s allegation that HC was administered a rousing agent during her recovery, which was disproven at the hearing. c. Dr. Caruso accepted that MC had “blood soaked” bandages, but this was not proven at hearing, and in fact, the bandages were almost certainly soaked in serosanguinous (tumescent) fluid.[5] d. Dr. Caruso was of the opinion that Dr. Zavala took a hemoglobin reading because HC had low blood pressure, whereas the evidence at hearing shows that Dr. Zavala does not agree that HC was hypotensive and that such readings are standard when the patient has a recovery time of more than a few hours. 37. In his June 14, 2014, Supplemental Report, in the “Summary and Final Recommendation,” Dr. Caruso wrote “This reviewer still feels that Dr. Zavala-Alarcon [fell] below the standard of care in terms of documentation and the detail of such documentation…. The performance of the procedure was justified and without technical issue.” 38. As such, Dr. Caruso explicitly affirmed his original opinion that Dr. Zavala’s record keeping deviated from the standard of care, but nowhere in his Supplemental Report did Dr. Caruso affirm his opinion that Dr. Zavala violated any standard of care regarding his treatment and care of HC during her second recovery.[6] Dr. Zavala’s Objection to Dr. Caruso’s Reports and Opinions 39. Dr. Zavala argues that Dr. Caruso is not qualified to render an opinion in this matter because he is not a cosmetic surgeon and lacks experience in liposuction procedures. This objection goes to the weight and probative value of Dr. Caruso’s opinions 40. Dr. Zavala also argues that the opinions of Dr. Caruso should be excluded because he does not meet the Board’s requirements for a medical consultant based on conflict of interest. 41. Dr. Zavala testified that while he was chief of cardiology at Maricopa Medical Center, Dr. Caruso was chief of surgery and a “turf war” developed. Dr. Zavala also testified that the two men had argued before hospital administration and as to his opinion that Dr. Caruso was a little bit demeaning to him. At one point, Dr. Zavala charted a note to which Dr. Caruso took offense, which led to a situation where Dr. Caruso would turn from Dr. Zavala whenever their paths crossed. 42. The Board submitted two affidavits from Dr. Caruso in which he states his belief that there was no conflict of interest and that there was no “turf war.” Dr. Zavala submitted affidavits from several persons who made statements in support of his position. 43. The Board’s Medical Consultant Orientation materials show that being an enemy of the respondent physician is a common conflict of interest. The Orientation also shows that even the appearance of impropriety constitutes a conflict and that the consultant should notify the Board if he may have a real or potential conflict. 44. There is sufficient evidence to show that Dr. Caruso’s past relationship with Dr. Zavala may create a conflict of interest, which affects the weight that can be given his opinions.[7] Michael Murray, M.D., Ph.D. 45. Dr. Murray is board certified in general internal medicine, in anesthesia and in two areas of critical care medicine. He teaches and lectures, and has written several textbooks on anesthesia and critical care medicine. 46. For the ten months prior to the hearing dates, Dr. Murray worked in outpatient surgical centers. Prior to that he worked at the Mayo Clinic for twenty-eight years and he also spent time on active duty working in military hospitals. 47. In addition to his testimony, Dr. Murray prepared a Medical Consultant Report and Summary and a Supplemental Report that were entered into evidence. 48. In his Medical Consultant Report, Dr. Murray opined that Dr. Zavala deviated from the standard of care by failing to provide adequate post-procedure care by failing to properly evaluate HC during the time she was in the recovery room. Dr. Murray’s Supplemental Report shows that he was still of the opinion that the standard of care for managing a patient in the recovery room of an outpatient surgical center was not met. 49. In forming his opinions, Dr. Murray was not aware that HC suffered from anxiety, that she was taking medication for it, or that she did not take her medication prior to the procedure on March 22nd. 50. Dr. Murray did not read HC’s hospital records and merely “glanced” at them because he was not asked to give an opinion on the care provided by the hospital. 51. Dr. Murray acknowledged that he did not know how much blood loss would be normal in a liposuction procedure such as HC’s. 52. Dr. Murray acknowledged that he did not understand why Dr. Zavala elected to hold HC for more than one to three hours; he read Dr. Zavala’s report, but he could not understand it.[8] 53. Dr. Murray testified that “The most important and most critical deviation from the standard of care was keeping the patient in the recovery room for seven hours after she had a, quote, quote, panic attack, clearly hyperventilating and tachycardic, but without an explanation.” 54. Dr. Murray’s testimony shows that he did not understand why HC was in the recovery room for as long as she was. The only reason Dr. Murray appeared to be aware of was that HC had a panic attack. 55. Dr. Murray’s testimony shows that he assumed that there must have been a medical cause for HC’s stay. Because there was no record of testing to show that Dr. Zavala was trying to identify the cause, he concluded that Dr. Zavala did not properly care for HC.[9] 56. Dr. Murray was of the opinion that postsurgical management is the same for all procedures, with some exceptions. He did not agree that post-procedure fluid-management for liposuction was different than fluid management for other procedures. Dr. Murray added however that fluid intake is restricted during recovery from any procedure. 57. Dr. Zavala argues that Dr. Murray is not qualified to render an opinion in this matter because he is not a cosmetic surgeon and lacks experience in liposuction procedures. This objection goes to the weight and probative value of Dr. Murray’s opinions. Michael L. Brownstein, M.D. 58. Dr. Brownstein is a board certified plastic surgeon whose specialty was transgender surgery. Early in his career, Dr. Brownstein did a lot of liposuction, but in the 1970s or 1980s as his transgender work expanded the number of liposuction cases dropped off dramatically, with the liposuction being ancillary to the transgender surgeries. During his career, liposuction was less than 5% of his work, and at the time of his retirement in 2012, 100% of his work was transgender surgery. 59. Dr. Brownstein acknowledged that in preparing his opinions he did some research to refresh his knowledge because he was retired and was not performing liposuction to any significant degree, and he acknowledged that he does not stay as current with medical journals as he did before he retired. 60. During his testimony Dr. Brownstein acknowledged that he could not say what the American Society of Plastic Surgeons’ 2009 standards regarding patient selection were. 61. Dr. Brownstein was not familiar with the super wet tumescent liposuction procedure that was used by Dr. Zavala.[10] 62. Dr. Brownstein spent his career working in San Francisco and it appears that his opinions related to the standards of care may have been based on requirements specific to California (and the preferences of the institutions at which he worked), rather than general standards of care. For example, Dr. Brownstein’s opinion was that standard of care required that any procedure in which more than 5000 cc was removed had to be conducted in an acute care hospital or setting. The evidence at hearing showed however, that this standard is found California’s regulations and that Dr. Brownstein was unaware of those regulations.[11] 63. Dr. Zavala argues that Dr. Brownstein is not qualified to render an opinion in this matter because he is not a cosmetic surgeon and because his area of expertise was transgender reconstructive surgery, not liposuction. This objection goes to the weight and probative value of Dr. Brownstein’s opinions. Michael Desvigne, M.D. 64. Dr. Desvigne is board certified in plastic surgery, general surgery, hyperbaric medicine, and wound care. 65. In January 2014, Dr. Desvigne was contacted by a recruiter and began investigating working with Dr. Zavala. In July 2014, he began working with Dr. Zavala on a two-day a week basis. Dr. Desvigne also maintains his own practice. Prior to joining Dr. Zavala, Dr. Desvigne performed plastic and cosmetic surgery for the Banner Health organization and was performing liposuction procedures in the Phoenix area. 66. Dr. Desvigne was aware to the incident at issue, but provided no testimony specifically about those events. 67. Dr. Desvigne testified positively as to Dr. Zavala’s skill and thoroughness as a surgeon, the quality of Dr. Zavala’s facility, Ms. Magnuson’s “superb” skills as a nurse, and Ciao Bella’s current process when conducting medical evaluations for patient safety and policies regarding recovery room stays. Jennifer Magnuson, R.N. 68. Ms. Magnuson graduated from nursing school in 2001. She worked for Advanced Cardiac Specialists for about seven years, which is where she met Dr. Zavala. In 2014, Ms. Magnuson became certified in conscious sedation techniques, but that certification is not a requirement for providing conscious sedation, and she administered conscious sedation on a daily basis while working at Advanced Cardiac Specialists (and has continued to do so at Ciao Bella). Ms. Magnuson also has an advanced cardiac support license. 69. After Advanced Cardiac Specialists closed, Ms. Magnuson contacted Dr. Zavala and, as of the hearing dates, had been working for him for about five and a half years. 70. Ms. Magnuson was the nurse providing conscious sedation to HC (under Dr. Zavala’s supervision) and also the nurse attending to HC in the recovery room. Melvin Shiffman, M.D. 71. Dr. Shiffman is board certified in general surgery and certified in cosmetic surgery by the American Board of Cosmetic Surgery (i.e., not the American Board of Medical Specialists, which does not certify cosmetic surgeons). 72. Dr. Shiffman practices in the areas of cancer surgery, reconstructive surgery, and cosmetic surgery. Although Dr. Shiffman still practices and performs liposuction, health issues have limited the number and nature of the procedures he now does. 73. In the last ten years, Dr. Shiffman has lectured extensively on tumescent liposuction technique, he has observed hundreds of procedures, and corresponded and interacted with other experts in the field. 74. Dr. Shiffman has been the editor of several cosmetic surgery journals, and was editor of the first and second editions of “Liposuction Practices and Principles.” The second edition was scheduled for release about thirty days after the hearing dates.

75. Dr. Brownstein testified that one could spend a lifetime reading what Dr. Shiffman has written and Dr. Shiffman testified that he had spent a lifetime writing. 76. Dr. Shiffman was also a surveyor or examiner for the Accreditation Association for Ambulatory Health Care. As part of his work in this matter, he conducted an evaluation of Ciao Bella following the same basic procedures he employed when working for that organization. 77. Dr. Shiffman’s opinion is that Dr. Zavala is a qualified cosmetic surgeon in this community and that, based on his review of the records, Dr. Zavala met the standard of care with respect to HC. The Cause of Death 78. The autopsy report shows that HC died of anoxic encephalopathy following resuscitation from cardiac arrest following liposuction of the back and arms for morbid obesity and that the manner was “natural.” 79. HC showed no signs of shock during the recovery. The autopsy did reveal signs of hemorrhagic fat in HC’s arms, but this is a natural consequence of the liposuction procedure, which creates trauma. 80. Dr. Murray’s opinion was that HC died of hemorrhagic shock. 81. Dr. Brownstein did not offer an opinion on the cause of death, but his testimony was to the effect that if exsanguination had been the cause of death, the autopsy report would have shown bruising or hematoma, which it did not. 82. Dr. Shiffman testified that there was no evidence of hemorrhage and to the effect that hemorrhagic shock was not the cause of death because the autopsy showed no signs of volumetric blood. 83. Dr. Shiffman’s opinion is that ordinarily deaths such as this one are caused by cardiac arrhythmia, but the cause cannot be proven. 84. Dr. Zavala also testified to the effect that the autopsy did not support a finding that the cause of death was hemorrhagic shock, and as to his opinion that the cause was sudden arrhythmic cardiac death. 85. There was information showing that paramedics who treated HC after she left Ciao Bella reported that she had blood soaked bandages. Dr. Zavala’s experience is that untrained individuals (those who have not seen a post-liposuction patient) can find the volume of fluid to be dramatic, but this fluid is only about 1% blood and is primarily the tumescent. 86. Dr. Shiffman also was of the opinion that what the paramedics saw was serosanguinous fluid, not blood.[12] 87. Dr. Fisher wrote that there was no evidence of blood loss from the procedure itself, specifically no excessive bruising, hematoma formation, or perforated organ or body cavity. 88. Dr. Murray testified that the autopsy report did not change his opinion that the cause of death was hemorrhagic shock and that it actually confirmed his opinion, because it showed of the abdomen: "The subcutaneous fat is hemorrhagic and has no volumetric blood accumulations." 89. Dr. Murray testified that he would not expect to see volumetric blood accumulations (i.e. measurable blood). When asked if he nevertheless thought that this was evidence of hemorrhagic shock, Dr. Murray explained that “Shock is defined on a physiologic basis. It's not found on an autopsy.” 90. Dr. Murray acknowledged that HC was never reported to be pale or ashen, that there were no signs that she had rapid ecchymosis, or hematomas or bruising. But he did not agree that these were signs of hemorrhagic shock, but rather his opinion is that they are signs of hemorrhage. 91. The weight of the evidence does not establish that HC died as a result of hemorrhagic shock. 92. The weight of the evidence does not establish that HC died as a result of Dr. Zavala’s actions. The Standards of Care and Alleged Violations 93. “The standard of care requires a physician to recognize when liposuction is not an appropriate treatment for body-contouring, obesity and/or weight reduction, and especially morbid obesity.” 94. The Board alleges that Dr. Zavala “deviated from the standard of care by performing liposuction when it was contraindicated for HC.” 95. The Board asserts that the “standard of care requires that any liposuction aspirate greater than 5,000cc requires the procedure to be performed in an acute care hospital or setting.” Dr. Zavala denies that this is the standard of care. 96. The Board alleges that Dr. Zavala “deviated from the standard of care by performing liposuction on patient HC in an outpatient setting at his own facility.” 97. “The standard of care requires that patients with comorbid conditions of diabetes and/or hypertension be properly screened preoperatively and properly monitored postoperatively.” 98. The Board alleges that Dr. Zavala “deviated from the standard of care by performing liposuction on HC, who was a sixty year old patient with diabetes and hypertension, without benefit of a preoperative evaluation by appropriate specialists or early transfer to an acute care facility and appropriate care after a prolonged and difficult postoperative course.” 99. “The standard of care requires a physician to provide adequate post-procedure care to the patient.” 100. The Board alleges that Dr. Zavala “deviated from the standard of care by failing to provide adequate post-procedure care.” 101. A physician must keep adequate records as set out in Ariz. Rev. Stat. section 32-1401(2). The Board alleges that Dr. Zavala’s medical records were inadequate and did not meet the standard of care. Dr. Zavala and Ciao Bella 102. Dr. Zavala received his initial training at the National Autonomous University of Mexico and training in cardiology at the National Institute of Cardiology in Mexico City. 103. Dr. Zavala then practiced internal medicine and cardiology, which at that time was primarily cardiac surgery, but as interventional cardiology began to develop, he was trained in that field and was board certified in both. 104. Concern for his family’s safety led him the move to the United States. He took and passed the USMLE exams and was licensed in California in 1997 (No. A 056463) and in Arizona in 1998. 105. Dr. Zavala served a residency at the Maricopa Medical Center from 1995 to 1998 and was chief resident in his last year, during which time he was participating in decisions related to cardiology patients. On his licensure in 1998, he joined the cardiology staff. 106. Dr. Zavala worked at Maricopa Medical Center for about ten years, during which time he developed an interventional cardiology program. Dr. Zavala was Director of the Cardiology department and vascular surgery at Maricopa Medical Center from 2002 to 2007 and Director of Cardiology at Phoenix Memorial Hospital from 2003 to 2006. 107. Maricopa Medical Center served many indigent people, and over the course of several years, Dr. Zavala became frustrated as the responsible health plan began denying coverage for what he considered to be even basic medications and procedures. Dr. Zavala felt he was ethically complicit in the situation and he decided to practice cosmetic surgery because he trusted his skill as a surgeon and because it is one of the few areas not dominated by the insurance industry. 108. Dr. Zavala trained in cosmetic surgery during a three year fellowship at the Millennium Cosmetic and Laser Institute in Tijuana, where about 60 to 70% of his work was liposuction. He worked there for about three years, initially primarily on weekends when an influx of Americans would obtain treatment, but in the last year he was there “pretty much all the time.” 109. Dr. Zavala did not pursue board certification in plastic surgery because of his age, and he was of a belief that because of his age, he would not have been admitted into a program for such. As of the hearing dates, Dr. Zavala was not actively practicing cardiology, but he was a reviewer for two cardiology journals and was board certified in internal medicine. 110. In 2007, Dr. Zavala founded Ciao Bella. 111. Dr. Zavala’s intention was that Ciao Bella would meet the standards for the plastic surgery setting and Ciao Bella has been accredited by the Accreditation Association for Ambulatory Health Care, which requires a review every three years. Dr. Zavala has a full-time person working to ensure that Ciao Bella meets these requirements. 112. Dr. Zavala had submitted into evidence Certificates showing Ciao Bella’s first accreditation expired in 2010, with subsequent certificates showing expiration dates of August 14, 2013 and August 14, 2016. 113. On June 4, 2015, Dr. Shiffman conducted an inspection of Ciao Bella. Dr. Shiffman found that Ciao Bella and its personnel met the Accreditation Association for Ambulatory Health Care’s standards. 114. In 2011, when the events at issue occurred, Ciao Bella had about fifteen employees and Dr. Zavala was the only physician (although other physicians who were being trained rotated through Ciao Bella). 115. As of the hearing dates, Ciao Bella had twenty-three employees including four surgeons, Dr. Zavala, his son Andres Zavala, D.O., a vascular specialist who now does the vein work, and two board-certified plastic surgeons, Carlos Mata, M.D., and Dr. Desvigne, and three full-time nurses trained in conscious sedation.[13] 116. Dr. Zavala associated with Drs. Mata and Desvigne, at least in part, as a consequence of the Board’s investigation in this matter, with a goal being to allow patients different perspectives and to ensure that there were no questions about whether the assessment and decision process had been thorough. 117. At Ciao Bella, Dr. Zavala initially performed a lot of vein procedures, which were closely related to his training in interventional cardiology, but then began to perform mostly liposuctions. Since he founded Ciao Bella, about 60% of Dr. Zavala’s work has been liposuction and he estimated that he had performed over 2000 “big” liposuction surgeries, meaning the torso and full thighs, and between 1000 and 2000 “small” procedures (e.g., neck or arms). 118. Throughout his career, Dr. Zavala has engaged in teaching, including teaching cardiology and liposuction. Dr. Zavala also published an article showing that lidocaine could safely be limited to a concentration of 400 milligrams of lidocaine per liter. The Patient and Procedures 119. HC was referred to Dr. Zavala by High Definition Liposuction for which Dr. Zavala had been training physicians in his liposuction technique. 120. HC was sixty years old and was morbidly obese with a history of diabetes and mild hypertension. HC’s obesity was not visceral, and the diabetes and hypertension were both well controlled. Dr. Zavala testified that he had rarely seen a patient with better controlled diabetes; her last A1c was 6, whereas 5.7 is a non- diabetic value.[14] HC was an insulin user, but not insulin dependent. 121. HC also had a history of anxiety, for which she took medication. Prior to her liposuction procedures, HC was required to stop taking certain of her medications, including anti-anxiety medications, because these had a potential to increase the risk of lidocaine toxicity. 122. Initially, Dr. Zavala consulted with HC and her husband, MC, by telephone. At that time he learned that HC had tried to lose weight, but had been unable to do so and that their concern was a lack of mobility, not esthetics. Dr. Zavala explained to HC and MC that liposuction was not a weight-loss procedure, but that many patients became more active after liposuction, which led to weight loss. 123. On January 4, 2011, Dr. Zavala conducted a formal consultation at Ciao Bella, which he described as the cosmetic exam. A history and physical and an exam were conducted, which included an EKG. 124. Dr. Zavala verified that HC was aware of the limitations of the procedure and that she would likely not see an esthetic improvement, and he emphasized that this was not a weight-loss procedure. Dr. Zavala explained that given the volume to be removed, he would be required to conduct HC’s procedure in three stages. 125. HC’s concerns included her large pannus and related skin issues and that she was getting more limited in her ADLs. Dr. Zavala discussed a panniculectomy that he performs and tummy-tucks. At some point, Dr. Zavala also talked to HC about bariatric surgery. HC was totally opposed to these kinds of surgery. 126. Dr. Zavala did not consider HC to be an ideal candidate for liposuction because the usual goal of liposuction is to make an esthetic improvement (i.e. it is cosmetic surgery). This opinion did not relate to her obesity or comorbidities; these are not unusual in Dr. Zavala’s practice and can be controlled. 127. The first procedure was scheduled for January 29, 2011. Prior to the surgery HC experienced an anxiety attack and left Ciao Bella. She then returned and the procedure was completed on that date. 128. On January 29, 2011, HC’s initial blood pressure was 173 over 59, which was higher than at the preoperative physical. Dr. Zavala found that to be normal and predictable for surgery patients. 129. On January 29, 2011, HC spent about, two and a half to three hours in recovery. In evaluating patients for discharge, Dr. Zavala uses the modified Aldrete Score. A score of nine or ten (out of ten) indicates that the patient can be discharged. 130. After the first session, HC wanted to get the second session scheduled quickly and it was set for March 22, 2011, in part to coincide with HC’s plans to be in Arizona at that time. 131. Ciao Bella has a waiting list for surgery, which must be considered when scheduling any procedure. In addition, Dr. Zavala considers factors including how well the patient did in the first procedure and recovery, and that the patient does not have unreasonable expectations. Because HC’s second session of liposuction would cover different areas of her body, and because she had had a good recovery and was more active, Dr. Zavala saw no problem with the March 22nd date. 132. On March 22, 2011, Dr. Zavala conducted a thorough physical exam of HC, at which time her blood pressure was 115 over 70. During the pre-procedure assessment it was 148 over 80, and when the procedure started it was 153 over 78. The elevated blood pressure readings were to be expected, given HC’s knowledge of what the second procedure would entail. 133. At the pre-procedure assessment, HC had a hemoglobin value of 11.8, which is normal for women. 134. Stress, including the stress of surgery, results in physiologic changes that raise glucose levels, which is controlled with insulin. 135. HC’s blood sugar was at 138, which is acceptable. Given her diabetes and insulin use, Dr. Zavala would routinely be checking the blood sugar during the procedure. 136. The only concern at the second pre-procedure assessment was once again HC’s anxiety, but HC was not as anxious as she was at the first session. 137. The second procedure began at 9:20 a.m. and ended at noon. 138. During the second procedure, Dr. Zavala removed 4.8 liters of fat (4800 cc) from HC’s back and arms. 139. Dr. Zavala was of the opinion that HC’s blood pressure stayed a little bit high during the second procedure because liposuction of the back is more painful than on the abdomen (even with very good tumescent and sedation). 140. After HC was able to walk (with assistance) she was transferred to the recovery room, where she was reattached to the medical monitoring equipment. Ms. Magnuson was present to monitor HC one- to-one with no other duties to attend to. Dr. Zavala was also attending to HC on an intermittent basis and available if Ms. Magnuson felt his assistance was required. 141. There may have been some issues getting a good blood pressure readings for HC, but nothing out of the ordinary considering that liposuction, which causes swelling, had been performed on HC’s upper arms. Blood pressure readings are taken by machine, but if she had any reason to doubt the machine, Ms. Magnuson took manual readings as a matter of course. 142. Dr. Zavala saw no evidence that HC was experiencing issues with her blood pressure during the recovery. To the contrary, her mean arterial pressure was seventy millimeters of mercury, whereas sixty millimeters allows for good perfusion. In addition, HC was drinking fluids, twice urinated, and was not tachycardic except during the panic attack. HC was never hemodynamically unstable. 143. Immediately after the second procedure, her blood pressure was at 116 over 60. Dr. Zavala considers a patient’s baseline blood pressure to be that which occurs when the patient is under no stress and experiencing no pain. 144. During the second procedure, Dr. Zavala considered HC’s baseline blood pressure to be 115 over 70. In contrast, Dr. Caruso wrote that HC “lives” with a blood pressure in the 150 systolic range. 145. When Dr. Murray was asked by the Board if he agreed that HC’s blood pressure showed a definite and persistent downward trend, but no life-threatening readings, he responded that he saw nothing alarming about HC’s blood pressure. 146. Drs. Fisher and Caruso were of the opinion that HC showed sustained hypotension during the second procedure. 147. Dr. Shiffman agreed that HC’s baseline blood pressure was 115 over 70. Dr. Shiffman was of the opinion that HC was not hypotensive while in the recovery room on March 22, 2011. 148. The evidence adduced does not show that “HC displayed relative and sustained hypotension and that her blood pressure exhibited a definite and persistent downward trend” during her recovery from the second procedure. 149. Routine blood sugar readings were taken and insulin was administered to keep the level below 200. 150. At about 13:30, HC appeared to be sleeping, when she suddenly jumped up in what was determined to be a panic attack. 151. Dr. Zavala had seen a lot of panic attacks when practicing as a cardiologist and he found these to be common. In HC’s case, her husband informed Dr. Zavala that the two nights prior to the second procedure HC had awoken with “night terrors” that were like the attack HC experienced in the recovery room. 152. HC’s panic attack was treated appropriately by having her breathe into a bag to increase the carbon dioxide in her system. 153. After the second procedure, HC spent just over eight hours in the recovery room. With the exception of the panic attack however, Dr. Zavala did not consider the second recovery to differ from first recovery, particularly with respect to her vital signs. 154. All liposuction patients are sleepy because they have been sedated. HC was sleepier during her second recovery than she was in the first, but she had been without sleep for two nights due to “night terrors” and during the second procedure she was given Benadryl, which prolongs the recovery. 155. MC had been insisting on returning to Sedona with HC that day, which would take several hours. This added to the time HC spent in recovery because Dr. Zavala wanted to insure that HC was totally calm before discharge to reduce the possibility that she might suffer another panic attack during the drive. 156. It was not until 5:00 p.m. that Dr. Zavala and his staff convinced MC not to drive to Sedona that night. Then it took time for the Ciao Bella staff to arrange for a hotel room. 157. On discharge, HC had an Aldrete score of ten. 158. Patient care is a paramount concern at Ciao Bella, which to Dr. Zavala means not only a good surgical result, but also patient comfort. Ciao Bella is not a mill, and patients who are nauseous or sleepy or in pain are not released. Other times patients are held simply because their caregiver is not in a position to adequately care for them or because the patient expresses a desire to stay longer.[15] 159. Dr. Zavala does not charge by the hour for recovery room time, the price for which is included in the overall price of the procedure, and there is no need to hurry patients out the door. Other than from a patient safety and comfort perspective, it does not matter to him whether the patient stays for two hours or overnight. 160. Dr. Zavala does not release patients until they are totally stable, which usually occurs within two hours, but other patients stay longer. Ms. Magnuson testified that every patient is different and there is no “normal” recovery time, but about 20% of patients stay in recovery for more than three hours. About once a month patients stay overnight for reasons including inadequate support at home, nausea, or sleepiness. 161. Dr. Zavala would have had HC transferred to a hospital if he had any concerns that she required a transfer. Admitting privileges would not have been required because HC could have gone to the emergency department. The Board alleges that Dr. Zavala deviated from this standard of care by performing liposuction when contraindicated for HC.

162. The Board alleges that Dr. Zavala deviated from the standard of care by performing liposuction when contraindicated for HC. In support of this allegation the Board presented the testimony of, and reports prepared by, Dr. Brownstein. 163. Dr. Brownstein’s opinion is that HC was not an appropriate patient for liposuction with removal of five liters of fat, and that her morbid obesity was a contraindication for liposuction. And in his Supplemental Report, Dr. Brownstein opined that to operate on HC for Dr. Zavala’s stated intentions is definitely a violation of standard of care for any practitioner doing liposuction.[16] 164. Dr. Brownstein’s opinion is not consistent with Dr. Fisher’s opinion that there was no deviation from the standard of care, nor is it consistent with Dr. Caruso’s opinions that a BMI such as HC’s was not necessarily a contraindication, that Dr. Zavala has the requisite knowledge of liposuction pros and cons, and that the performance of the procedure was justified. 165. Dr. Shiffman’s opinion was that HC was an acceptable candidate for the procedure and he did not agree that morbid obesity was a contraindication for liposuction. He did agree however that liposuction was not appropriate as a weight loss measure. 166. Dr. Shiffman testified that HC met the American College of Cardiology and The American Heart Association 2007 guidelines on perioperative cardiovascular evaluation for noncardiac surgery.

167. HC was rated at a two on the American Society of Anesthesiologists’ rating, because although she had comorbidities, these were under control, and she had no heart or lung problems, which was confirmed by the autopsy. A patient rated at a two on this scale is considered to be a suitable candidate for surgery. 168. Dr. Shiffman did not agree that controlled hypertension or controlled diabetes necessarily puts a patient at higher risk. And he testified that one of the reasons patients with diabetes and hypertension are considered acceptable for liposuction is that liposuction can help ameliorate both. 169. Dr. Shiffman did not agree that a 5000 cc removal of fat was a riskier procedure than a lesser volume, and he was of the opinion that the risk did not increase until the “mega- liposuction” range of over 10,000 cc was reached. 170. Dr. Shiffman agreed that age could increase the risk to a patient, but that was primarily in cases of general anesthesia. He also testified that the time it took to complete HC’s procedure was short enough that her age was not a risk factor. 171. Dr. Brownstein took the position that HC’s second procedure was staged too closely to the first. In contrast, Drs. Fisher and Caruso considered the first procedure to be a factor in mitigation. 172. The evidence adduced does not show that liposuction was contraindicated for HC or that Dr. Zavala deviated from the standard of care by performing liposuction on HC. The Board alleges that Dr. Zavala deviated from the standard of care by performing liposuction on HC in an outpatient setting at his own facility.

173. The Board takes the position that the standard of care requires that any liposuction with aspirate greater than 5000 cc requires the procedure be performed in an acute care hospital or setting.

174. The Board alleges that Dr. Zavala deviated from the standard of care by performing liposuction with an aspirate of greater than 5000 cc in a facility other than an acute care hospital or setting. 175. Dr. Brownstein’s opinion was that liposuctions with greater than 5000 ccs of removal must be conducted in a hospital or acute care setting. Dr. Brownstein had no knowledge of, and no opinions about, Ciao Bella’s equipment, certifications or personnel. This information was not pertinent to Dr. Brownstein’s opinion, which was, in effect, that there is a per se requirement. 176. Drs. Fisher and Caruso found no deviation from standard of care in this regard. 177. Dr. Shiffman testified that California there are regulations that require large liposuction procedures to be done in a hospital, but absent such a regulation, there is no standard of care that requires it. 178. Dr. Brownstein was not aware that the 5000 cc limit was a requirement of California’s regulations. 179. Dr. Shiffman testified that the American Society of Aesthetic Plastic Surgery’s 2009 guidelines show that a procedure such as HC underwent should be done in a hospital or in an accredited facility. Ciao Bella is such an accredited facility. 180. The evidence adduced does not show that standard of care requires that liposuction with an aspirate of greater than 5000 cc must be performed in an acute care hospital or setting. 181. The evidence adduced does not demonstrate that Dr. Zavala deviated from any standard of care by performing the procedures at issue at Ciao Bella. The Board alleges that Dr. Zavala deviated from this standard of care by performing liposuction on HC without benefit of a preoperative evaluation by appropriate specialists.

182. The Board alleges that Dr. Zavala deviated from the standard of care by performing liposuction on HC without benefit of a preoperative evaluation by appropriate specialists. 183. Dr. Zavala conducted the preoperative evaluation on HC. 184. Dr. Brownstein testified that there was “potentially” a bias on Dr. Zavala’s part, but he acknowledged that the examination was “probably complete enough.” 185. Dr. Fisher concluded that Dr. Zavala’s pre-procedure evaluations were within the standard of care, and Dr. Caruso acknowledged that the preoperative work-up was probably sufficient. 186. Dr. Shiffman testified that: Dr. Zavala was qualified to his own preoperative evaluation based on his training and experience as a cardiologist and as a medical internist; both preoperative evaluations were done in accordance with the standard of care; he did not see that there was anything “missing” from the March 22, 2011 evaluation; he did not see any evidence that Dr. Zavala’s evaluations were not objective; and that standard of care did not require Dr. Zavala to obtain HC’s medical records. 187. As a cardiologist, Dr. Zavala did “a ton of clearances for many surgeons,” and it was one of the things he did almost every day. Performing these clearances was “sacred” to Dr. Zavala and required assessing the safety of the procedure, the status of the patient, and the abilities of the surgeon. 188. The evidence adduced does not show that Dr. Zavala was not competent to do the preoperative evaluation or that he did not conduct a proper preoperative evaluation.[17] 189. The weight of the evidence does not show that Dr. Zavala deviated from the standard of care by “performing liposuction without benefit of preoperative evaluation by appropriate specialists.”[18] The Board alleges that Dr. Zavala deviated from the standard of care by performing liposuction on HC, who was a sixty year old patient with diabetes and hypertension, without early transfer to an acute care facility and appropriate care after a prolonged and difficult postoperative course, and by failing to provide adequate post-procedure care.

190. The Board alleges that Dr. Zavala deviated from the standard of care by performing liposuction on HC without early transfer to an acute care facility and appropriate care after “a prolonged and difficult postoperative course” and that Dr. Zavala deviated from the standard of care by failing to provide adequate post- procedure care. 191. Dr. Caruso’s opinion that HC did not receive adequate post- procedure care appears was based (at least in part) on his opinion that she was hypotensive during the recovery. As set out above however, there is disagreement about how to interpret HC’s blood pressure readings and it was not proven that she was hypotensive.[19] 192. Dr. Murray’s opinion that Dr. Zavala violated the standard of care was based on his belief that HC’s panic attack would not require more than two hours of recovery. But as set out above, Dr. Murray did not understand why HC remained in the recovery room as long as she did. 193. Dr. Brownstein’s understanding was that the recovery time was based on the panic attack and on cross examination he testified to the effect that he was not aware that there was a concern related to MC’s plan to drive HC to Sedona. 194. Dr. Caruso’s opinion is that standard recovery times in hospitals are sixty to ninety minutes, and few and far between are those of two to three hours. Dr. Caruso added that the cause of the longer recoveries must be determined through a thorough review of the peri-operative course and current status, and then it must be determined if this recovery is “out of the norm” such that an overnight stay is required. Similarly, Dr. Murray’s opinion was that if a recovery room stay in an outpatient facility lasts longer than two hours, a search for the cause must be conducted. 195. Although Dr. Zavala did not agree to the time limits Drs. Caruso and Murray espouse, in effect, he complied with Drs. Caruso’s and Murray’s opinions in this regard because he was aware of HC’s medical status and aware of why her recovery extended beyond the proposed time limits. 196. In HC’s case, there were at least five factors that caused her “prolonged” stay in the recovery room: Dr. Zavala’s emphasis on the patient’s comfort and experience; MC was insisting on returning HC to Sedona; she had a panic attack; she was sleep deprived; and after MC relented and agreed to stay locally, it took time for Ciao Bella’s staff to locate a room. 197. Dr. Shiffman’s opinion was that HC’s post-operative care was appropriate and safe. Considering that HC had been medicated, the fact that she was sleepy but arousable, was not a problem. The length of recovery depends on patient and the doctor. Patient care dictates how long the recovery is; Dr. Shiffman’s patients averaged a recovery time of about four hours. In a hospital a standard time of one or two hours is appropriate so that the recovery room can be used by other patients; the same does not hold true in a private facility. 198. Dr. Shiffman saw no evidence that HC required any additional testing during her second recovery and conducting tests that are not required violates the standard of care. 199. The evidence of record does not show that HC had a difficult post-operative course. 200. The evidence of record does not show that Dr. Zavala deviated from the standard of care by failing to provide HC with adequate post-procedure care. The Board alleges that Dr. Zavala’s medical records were inadequate and did not meet the standard of care.

201. The Board alleges that Dr. Zavala’s medical records were inadequate and did not meet the standard of care. 202. Dr. Fisher determined that there were no deviations from the standard of care. Several of the Board’s other consultants were of the opinion that Dr. Zavala had failed to document the interventions he took during HC’s recovery. The evidence of record shows however, that there were no such interventions and that these consultants’ opinions were based on misunderstandings of the applicable facts or on differences of medical opinion related to HC’s blood pressure. 203. Ms. Magnuson was doing the charting using “charting by exception,” which is an established way for nurses to chart. Only material or significant changes are charted, so for example, if the patient requested water or briefly woke up and then went back to sleep, those entries would not be charted (unless the reason for waking was pain).[20] 204. Ms. Magnuson testified as to her opinion that the charting met the standard of care based on her training as a nurse. 205. The Board presented no evidence to rebut Ms. Magnuson’s testimony or to show that charting-by-exception was not within the standard of care. 206. Considering Dr. Fisher’s opinion and Ms. Magnuson’s unrebutted testimony, the Board has not shown that Dr. Zavala deviated from the standard of care by maintaining inadequate records. Other Issues Hemodilution 207. Dr. Zavala routinely takes hemoglobin values when a patient experiences other than a short recovery. The purpose is to check for hemodilution as the tumescent fluid gets absorbed, which will not occur until about three hours after the procedure. 208. During HC’s second recovery, at 18:30 a hemoglobin value of 10.5 was recorded. Although this was lower than the preoperative value of 11.8, Dr. Zavala considered it to be normal considering the volume of tumescent fluid used. Dr. Brownstein also testified that the infusion of fluid causes some hemodilution. 209. While at the hospital, HC had a hemoglobin reading of 5.5, which her treating physician found to be caused at least in part by dilution. 210. Drs. Caruso[21] and Murray were of the opinion that it would have been physiologically impossible for the fluids HC received to cause the hemoglobin reading of 5.5 by dilution, and Dr. Murray’s opinion was that the fluid would not have a measurable effect. 211. On the other hand, Dr. Murray also agreed that it would have been physiologically impossible for HC’s hemoglobin to have risen from 4.6 to 13.6, which it did, based solely on the 3 units of blood that she received in the hospital. 212. The evidence adduced does not show that Dr. Zavala caused HC’s hemoglobin values to drop below that which would expected in a large volume liposuction procedure. Admitting privileges 213. Admitting privileges are not a requirement for cosmetic surgeons in Arizona (or California). 214. Dr. Zavala did not have admitting privileges in March 2011, because he did not believe they were necessary. He has obtained privileges since then, but has never used them. Because he has not admitted five patients every two years, he is required go through the process of obtaining them again each two years. EKGs 215. HC had a bifascicular block that appeared on her EKG prior to the first procedure. These are not uncommon and about 10 to 15% of the population over sixty or sixty-five have them.[22] 216. Dr. Zavala’s preoperative evaluation showed that HC had no ventricular limitation, no ventricular hypertrophy, no valve disease, and no ischemic heart disease. 217. An EKG conducted at the hospital at or about the time that HC was in code arrest, shows what was possibly an infarct. 218. Dr. Shiffman testified that a later EKG and the autopsy report both show that there was no infarct, and that the autopsy report shows that the vessels and entire cardiovascular system were clear. CONCLUSIONS OF LAW 1. The Board is the duly constituted authority for licensing and regulating the practice of allopathic medicine in the State of Arizona. This matter lies within its jurisdiction. See Ariz. Rev. Stat. § 32-1401 et seq. 2. The Board alleges that Dr. Zavala committed unprofessional conduct by violating Ariz. Rev. Stat. sections 32-1401(27)(e), (27)(q), and (27)(ll). The Board has the burden of proof by clear and convincing evidence to show that the alleged violations occurred. Ariz. Rev. Stat. § 32-1451.04. 3. Clear and convincing evidence is “[e]vidence indicating that the thing to be proved is highly probably or reasonably certain.” Black’s Law Dictionary 674 (10th ed. 2014). 4. The scope of the hearing is limited to matters officially noticed. See Ariz. Rev. Stat. § 41-1092.07(F)(6). 5. The standard of care generally is “what is recognized as acceptable in the community of physicians involved in [a] practice” and may consider individual physicians’ personal approaches to patient care. Smethers v. Campion, 210 Ariz. 167, 175 ¶ 28 and n.7, 108 P.3d 946, 954 (App. 2005) (citing authorities). 6. A physician commits unprofessional by failing or refusing to maintain adequate records on a patient. Ariz. Rev. Stat. § 32- 1401(27)(e). 7. The Board has not shown by clear and convincing evidence that Dr. Zavala’s records for HC were inadequate. The Board has not shown by clear and convincing evidence that Dr. Zavala committed the alleged violation of Ariz. Rev. Stat. section 32- 1401(27)(e). 8. A physician commits unprofessional by engaging in conduct that is or might be harmful to the public. Ariz. Rev. Stat. § 32- 1401(27)(q). The Board has not shown by clear and convincing evidence that Dr. Zavala committed the alleged violation of Ariz. Rev. Stat. section 32-1401(27)(q). 9. A physician commits unprofessional conduct by engaging in conduct that “the board determines is gross negligence, repeated negligence or negligence resulting in harm to or the death of a patient.” Ariz. Rev. Stat. § 32-1401(27)(ll). The Board has not shown by clear and convincing evidence that Dr. Zavala committed the alleged violation of Ariz. Rev. Stat. section 32- 1401(27)(ll). 10. Consequently, the Complaint in this matter should be dismissed.

RECOMMENDED ORDER IT IS ORDERED that the Complaint in matter MD-13-0426A is dismissed. In the event of certification of the Administrative Law Judge Decision by the Director of the Office of Administrative Hearings, the effective date of the Order is five days after the date of that certification.

Done this day, January 20, 2016.

/s/ Thomas Shedden Thomas Shedden Administrative Law Judge

Transmitted electronically to:

Patricia E. McSorley, Executive Director Arizona Medical Board ----------------------- [1] Other statements in MC’s Complaint were neither proven nor disproven at the hearing. Of particular import is MC’s assertion that his narrative was written the day after HC’s death (rather than at the time the Complaint was filed). [2] As set forth below, the experts did not all agree that HC’s blood pressure showed this trend, and at the hearing it was not proven to have occurred. [3] Dr. Zavala does not agree that HC was hypotensive, and the Dr. Caruso has misconstrued the facts regarding the discharge to a hotel. [4] In particular, Dr. Caruso was of the opinion that Dr. Zavala failed to treat this hypotension. [5] In his Supplemental Report, Dr. Caruso wrote that the fact that the Board’s reviewers were not trained in liposuction may be true, but was “meaningless.” It appears reasonable to conclude that doctors experienced in liposuction would not have taken the report of blood soaked bandages at face value and would have questioned whether it was actually tumescent fluid. [6] Dr. Caruso did not explicitly disavow that conclusion, and he continued to maintain that HC was hypotensive. [7] Whether there was an actual conflict is a question that may have been resolved if Dr. Caruso had been subject to cross examination. [8] Dr. Murray was not present when Dr. Zavala testified and he was never asked whether that testimony clarified Dr. Zavala’s reasoning or caused him to change his opinion regarding the amount of time HC spent in recovery. [9] In his testimony, Dr. Murray appeared to say that Dr. Zavala violated the standard of care by releasing HC without knowing why she had a long recovery. [10] Dr. Brownstein was familiar with tumescent liposuction. [11] The evidence also shows that other states may have similar restrictions. [12] Although Dr. Shiffman testified as to the 1%-value, he also noted that there are studies showing a content of 2 to 3%. [13] The doctors are actually independent contractors. [14] Dr. Shiffman testified that an A1c of 6 could be considered non- diabetic. [15] In contrast, Dr. Murray made a point about how he had convinced a patient who did not want to leave recovery to do so. [16] Dr. Brownstein, in his Supplemental Report, also opined that with respect to Dr. Zavala’s written statement that the procedure was not for weight loss, but to rather reduce the size of HC’s pannus to improve her lifestyle, liposuction is not an adequate treatment for this because it does not address the excess skin and that a panniculectomy is more appropriate. [17] To the contrary, the weight of the evidence shows that Dr. Zavala is competent to conduct the evaluation and that his preoperative evaluations met the standard of care. [18] The experience with HC and the Board’s investigation has caused Dr. Zavala to reevaluate everything he was doing. One thing that he changed is that as of the hearing date, he asks the PCP whether a patient can undergo the procedure, and he sends patients to a cardiologist if review by a cardiologist is necessary. Dr. Zavala then does his own evaluation of each patient and will not do a procedure if he has any concerns, even if the PCP has given their approval. Dr. Desvigne testified that he “was quite comfortable” with Dr. Zavala’s evaluations of patients, albeit that it is safer for the patient to receive both the outside evaluation and Dr. Zavala’s. [19] Also, as set out above, on the evidence adduced, it is not clear that at the time Dr. Caruso wrote his Supplemental Report he was still of the opinion that HC did not receive adequate post-procedure care. [20] While this matter has been pending, Dr. Zavala became more involved in the charting and Ciao Bella has stopped using charting by exception, despite the fact that he finds that the new method fills charts with repetitive information that is not necessary. As an example, under the old method, if a patient was not feeling any pain, that section of the chart would be left blank, whereas now “no pain” is recorded repeatedly. [21] Dr. Caruso based his opinion on his belief that HC was hypotensive and on the report that she had blood soaked bandages. [22] Dr. Zavala included.

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