3?1 A. FROM LLUSM SURGERY CHAIR 989 558 21118 R. 1 Lame Linda University Medical Center Department omeger Chairman ?8 Of?ce 111 75 Campus Street, Room 21120 Loma Linda, CA 92354 (905?) 558-8 744 (909) 553-411? (For) FACSIMILE COVER SHEET Date: 3/12/2008 Time: 4:46 PM To: Sarah Frazier Location: Berg (ng Andronhv Fax No.: 713-529-3785 No. of Pages (including never eheet): 30 From: Leonard L. Bailov. MD Comments: Con?dentiality Notice The in?ammation contained in this facsimile document may contain information that is privileged. mn?dential, and exemp: from disclosure under applicable law. and Is inlendcd for rho use of the individual or cmity named above. If the recipient or reader of this document is not the intended recipient. or the employee or agent responsible for delivering :11: message to the intended recipient. you are hereby noti?ed that any dissemination. distribulim. 0r naming of this communicazion is strictly prohibited. H'you have received this communication in error, please notify us immediately by telephone. and return the original message To us at the above address. Thank you. 3-12?3218 FROM SURGERY CHAIR 9.9 558 211.1 18 P. 2 1 March 11, 200a 2 3 4 Stage: i?ai-dndroph? . 75 camper 3mg at 21:20 .0:ng AB Lam Linda, carafe; er'a 92354 Chm? - (.909) 5:2":51421 N4 6 3704 Trams Street . Fax: (909) ass-411 a TX 77002 7 Dear hit. Androphy: 9 You asked me to review medical records and other documents pertaining to 10 Civil Action No. Iii?944996, U. 8., ex rel Joyce Riley vs. St. Luke?s Episcopal Hospital, 11 12 et al. I have done that, and my Opinions follow. INTRODUCTION AND QUALIFICATIONS First, let me introduce myself. My name is Leonard L. Bailey. I am 65 years 15 old. I am a graduate of Loma Linda University School of Medicine. I completed surgical internship, a general surgical residency, and a residency in cardiothoracic is surgery each in the accredited programs at Lorna Linda University Medical Center and its affiliated hospitals. 1 completed a one?year fellowship in pediatric cardiac 22 surgery at The 1-105pital for Sick Children, Toronto, Ontario, Canada, and joined the 23 teaching facolty of Loma Linda University in 1976. I am certified by the American 24 '25 Board of Surgery and the American Board of Thoracic Surgery, with which I?ve been 25 most recently recero??ed in 2007. I am licensed to practice medicine and surgery in the state of califon?a. I am a full?time academic surgeon at Lorna Linda University in southern California, where I hold the rank of Distinguished Professor of Surgery. I 1 A SE INSTITUTION 3-12-2855 d:d9PM LLUSM SURGERY CHAIR 989 558 .4118 LII was Chairman of the Department of Surgery of Lorna Linda University and its School of Medicine between 1992 and 2007. In addition, I was Chief of Surgical Services at Lorna Linda University Medical Center. Presently, I am the Surgeon?in- Chief at Lorna Linda University Children?s Hospital. I have been actively engaged in the hill-time practice of cardiac surgery since July, 1976. My clinical practice has, since 1985, included cardiac tran5plantation in infants, children, and adults. I Originated the heart transplantation program at Lorna Linda University, where the ef?cacy of neonatal heart transplantation was first demonstrated, and where I am the of?cial director of cardiac transplantation services. The Loma Linda University heart transplant team has been responsible for over 600 heart transplantation procedures, including more than 35 re?transplanta?on operations. I have been the primary surgeon for nearly 250 of these cardiac transplantation procedures, and I have ?rst-assisted-with more than 100 others. I have participated in the training and mentorship of several dozen cardiothoracic surgical residents and both American and International research and clinical fellows. More information can be found in my curriculum vitae. You engaged my services as an expert on July 13, 2007, under the following ?nancial structure: Retainer of $4,500 by check made payable to Faculty Physicians and. Surgeons of Loma Linda University School of Medicine tax ID ?United for Organ Sharing, Richmond, Virginia. [0 3-42?2813 FROM LLUSM SURGERY CHAIR 9E9 558 ?1118 33-0672915. You are billed by for my services at the rate of $1,500 per how: for any additional time beyond the first three hours covered by the retainer. I would prefer to have my testimony at deposition or for trial taken at Lorna Linda University by Video or telephone conference at an hourly rate of $2,000, not to exceed $8,000 per day. If I am required to travel for testimony at deposition or trial, you will need to prearrange and lure-purchase first-class airline tickets (American Airlines Whenever possible), hotel, meals, and limousine transport in addition to my hourly rate of $2,000, that shall not exceed $10,000 per day. During the past four years, I rendered expert opinion and! or courtroom testimony in the following civil actions: Michelle Everwine and Christopher Everwine, as parents and natural guardians of Joshua Evermdne, a minor, Plainti?'s vs. Civil Action 05-3004 The Nemours Foundation, et a1, Defendants 3?12w283 Michael Roger and Kathleen Eager, as parents and natural guardians and admir?strators of the estate of Nicholas Roger, a miner, deceased, Plafnn??s vs. The emours Foundation, et a1, Defendants Allison and Paul Svindland, parents of Ian Svirtdland, Plaz?n??s vs. The Nemours Foundation, et a1, De?ndants Juliann Kerr and Adam Kerr, Plailm?'s vs. The emours Foundation, et a1, Defendants FROM LLUSM SURGERY CHAIR 558 4118 Civil Action 05-0661 Civil Action 05-00417 Civil Action 05-0662 25 26 27 23 Robert Daddio, as parent and natural guardian and administrator of the estate of Michael Daddio, a minor, deceased, and Robert Daddio and Tracie Daddio, individually and in their own right, Plaintiffs vs. A. I. duPont Hospital for Children, et a1, Defendants Gina Bonafede, administrators of the estate of Angela Bonafede, vs. Dartmouth Hitchcock Medical Center, Defendant In addition to my brief biography above, FROM LLUSM SURGERY CHAIR 999 558 4118 Civil Action 05-0441 Civil Action 05?0060 details of my academic career, publications, etc. can be found in the accompanying curriculum Vitae. FROM SURGERY CHAIR SEQ 558 ?1116 RECORDS AND DOCUMENTS REVIEWED case No. 1194?3996, U. 5. ex rel Riley vs. St. Luke?s Episcopal Hospital, et al, I have reviewed the following decuments: A copy of Federal Rule of Civil Procedure Plaintiff-Relator?s Third Amended Cemplaint filed May 16, 2007 Plaintiff?Relator?s Fourth Amended Complaint filed September 24, 2007 Deposition of Edward Massin, MD, dated July 27, 2007 Deposition of Joyce RileY, dated June 13, 2007 Plaintiff?Relations Designation of Expert Witnesses, and related materials ?led January 31, 2008 Deposition of O. H. Frazier, MD, dated October 24, 2007 Medical Records for Patient 1153455 (paper and digital) Medical Records for Patient 0524725 (paper and digital) Medical Records for Patient 1251716 (paper and digital) Medical Records for Patient 1108146 (digital only) Medical Records for Patient 1300735 (digital only) The False Claims Act (31 U.S.C. Sections 372963) Deposition of Ronald E. Bunger, dated October 1, 2007 3-12-2918 FROM SURGERY CHAIR 9E9 558 (1'opinions are a re?ection of my review of the above?described documents - and are based on my personal experience over three decades of practice, teaching, and research in cardiothoraeic surgery, including cardiac transplantation. 1. SUWINLARY OPINION My review of the documents and records listed previously suggests to me that Plaintiff-Renter Joyce Riley?s complaint challenges the defendant?s policies and procedures relating to the care of patients with end?stage heart failure before. during, and after cardiac transplantation. This complaint focuses on an earlier era in the development of clinical cardiac transplantation, ranging from the late 1980?s to the mid?1990's. Management of end-stage heart failure during that era was largely hospital-based, both in America and abroad- The complaint alleges two common themes in the defendants? evolving practice of providing medical and surgical care of patients Who were in the end-stages of heart failure. One allegation implies that many hospital admissions for these patients who were suffering from end?stage heart failure were either improper or downright contrived (?arti?cial?). A. secondary theme is that heart failure patients were transferred impmperly back and forth between basic care rooms and intensive care units at St. Luke?s Episcopal Hospital. This, it is alleged, was a form of programmatic chicanery designed to enable potential heart transplant recipients to advance on the UNOS 3-12w2l218 FROM SURGERY CHAIR 969 558 ?1118 (waiting list (thereby receiving a donor organ sooner). In addition, venue changes during the patients hospitalization were accomplished, it is alleged, as part of an organizational conspiracy to facilitate increased hospital and physician billings to Medicare. The complaint alleges that because patients were permitted simple requests, such as brief periods of nursing-assisted walking, or brief visits with family members and the like, that their hospitalization and intensive care surveillance was unnecessary and, therefore, inappropriate. The complaint alleges that these simple (often no more than 20?minute) activities negated the patient? 5 need to be hospitalized or managed in an intensive care environment. Plaintiff?Relator Joyce Riley?s complaint further alleges that Dr. Branislav Radovancevic was engaged in the practice of medicine without-a Valid license from the State of Texas, a fraudulent behaviOI that was supported by defendant St. Luke?s Episcopal HoSpital. This complaint is based on Dr. Radovanceidc?s name (or nicknames ?Brano,? or ?Bruno,?- or "Brauno?) appearing from time to time in nursing and physician notes within patients' records. In addition, Plaintiff-Relator Joyce Riley alleges that?Dr. Radovancevic was fraudulently engaged in the organ recovery process through Life Gift, Inc, a Texas-based organ procurement agency. In all, the Plaintiff-Relator listed approximately 30 direct and indirect references to Dr. 3?12?2l38 FROM LLUSM SURGERY CHAIR 9E9 558 11118 Radovancevic, references which were discovered to exist Within the complete hospital and Outpatient records of the ?ve individual patients surveyed. Plamtiff-Relator Joyce Riley?s complaint, in essence, suggests that there existed a broad, multi?instiui?onal conspiracy in Houston relating to the heart support program based at St. Luke?s Episcopal Hospital. This conspiracy was aimed at enabling the hospital and its physicians to fraudulently increase their billings and revenues through the Federal Medicare program. Additionally, the conspiracy was designed to speci?cally cover up the alleged clandestine practice of medicine by transplant team member Branislav Radovancevic. It is my view that Plaintiff?Relator Joyce Riley?s complaints are based on a fundamental ignorance of the gravity of end-stage congestive heart failure, and the evolution of its manageth both in the heapital environment and outside. Furthermore, I believe the plaintiff?s cemplajnts are based on an important misperception relating to the composition and function of a hospital?based heart transplantation team, which is a collaborative group of professiOnals charged with the management of end?stage heart failure recipients, before, during, and after cardiac transplantation. With regard to Plaintiff?Relator?s ignorance of the gravity of end-stage congestive heart failure, it is my opinion that each of the patients reviewed in this action met .18 3?12?2918 FROM L.L.LJSM SURGERY CHAIR SIZEcriteria for end?stage congestive heart failure, and all but one, who became too advanced in the course of his illness to remain suitable, were valid candidates for cardiac transplantation. Statistically, one of the four candidates who were ultimately transplanted, would have been expected to die before a donor heart became available. However, none of the four waiting candidates died prior to transplantation. This suggests to me that their pie?transplant care was thoughtfully and superbly accomplished. Patients with end?stage congestive heart failure are exceedingly vulnerable to such terminal events as sudden cardiac death, stroke, multi-organ failure (particularly lung, liver, and kidney), hemorrhage relating to anticoagulation, and infection relating to their general state of disability. In addition, many such patients have a vast array of collateral illnesses, including obesity, atherosclerosis, hypertension, and diabetes. Many potential candidates for cardiac transplantation fail to be registered for the procedure because of the extreme nature of their collateral illnesses. One such patient reviewed for this action failed to remain registered with UNOS for cardiac tramplentation because of the advancing nature of his. collateral illnesses; specifically, his lung vascular pathology. It is the responsibility of any cardiac transplantation team to thoroughly evaluate and rte-evaluate patients with end-stage heart disease to be absolutely certain that they either meet or fail to meet current criteria for 10 .11 3?12-2218 FROM LLUSM SURGERY CHAIR 989 558 3.118 heart transplantation, and then act accordingly. This is a particularly .: important process for an avant-garde transplant team, such as the St. Luke?s Episcopal Hospital team, which has contributed heavily to the worldwide development of accepted standards for heart transplantation. Of course, where each individual candidate (a person, a human being with family and friends) for heart transplantation is concerned, the decision for or against this ?last hope" procedure can be exceedingly complex, particularly in marginal cases, and when criteria might still be in flux, pending clinical research outcomes. Because of the capricious nature of end-stage heart failure with regard to catastrophic and frequently terminal events, much of the care of patients with this illness, during the era cited in this action, was accomplished in UNOS-approved transplant medical centers such as St. Luke?s EpiscoPal HoSpital. And, much of that observation and care was rendered in intensive care wards within these specialized. hospitals. Patients were admitted, evaluated, and vigorously treated. This often involved the use of diuretics, to reduce the potential for lethal and intravenous heart stimulants. Patients? florid congestive heart failtIre would usually improve someWhat with this type of intense medical management. During the are cited in Plaintiff?Relator Riley?s complaint, physicians were still 11 .12 3-42-3218 FROM LLUSM SURGERY CHAIR SE19 558 1.1.118 learning the limitations of administering intravenous heart stimulants in envirorunents other than within an intensive care unit. Patients were placed in intensive care and administered fairly generous doses of intravenous heart stimulants. As their heart function improved, the stimulants would he weaned down, and sometimes discontinued. And for a period of time, improvement in the patient?s heart function might persist. During this time of improvement, these patients may have been transferred for observation to basic hospital wards, or even managed as outpatients. lnevitably, however, they would once again decompensate and require readmission to the hospital, where additional intravenous heart stimulants would be expected to produce a gradual, but limited recovery of heart function. Again, this recovery might persist for a few days, weeks, or even months. This cycle might be repeated dozens of times during a potential recipient?s wait for a donor organ. Today, after nearly two decades of experience, there has been a gradual shift in the management of these patients from ill-hOSPita]. venues to outpatient facilities. Their lives have been made somewhat safer and considerably more palatable, in terms of their environment. Their New York Heart Association classi?cation, a measure of personal and physical freedom, has been gradually enhanced by the use of newer combinatiOns of drugs. In the era covered by this complaint, however, much of the cyclical medical management, 12 -13 3?12-238 FROM LLUSM SURGERY CHAIR 91219 558 r1116 17 1.8 19 20 particularly as it related to pre~transplant patients, was accomplished in the hospital, and a large portion of it in intensive care units. The experience of the five patients included in this action is representative of this mode of appropriate and successful pre?transplant surveillance and care. After carefully reviewing the records of patients that were cited in this action, it is my opinion that each individual patient was managed cautiously and appropriately.? Care was focused on treating these vulnerable individuals as human beings, granting them minor exceptions to ordinary rules, so they might experience some level of self-detennination. They did not appear to be objects of impersonal investigation, nor of seine ill-conceived fraudulent scheme to obtain additional revenues from Medicare. Nor did they appear to be participants in some consPiracy to game the waiting list rules, established through UNOS. In fact, many of the rules for organ distribution were still. evolving, during the era outlined by this action, and were being forged by panels of' physicians and surgeons that included Dr. Frazier and myself, among many others, to ensure appropriateness and fairness of organ distribution. I could ?nd no pattern of behavior on the part of the St. Luke?s Episcopal Hospital transplant team to circumvent the era-specific UNOS rules 'My review afirzdividual patient records, plaintiff complaints, and my opinion, beet-d on review of said follows later in this report. 13 -ld. 3-12?288 FROM LLUSM SURGERY CHAIR .989 558 ill 18 10 1.and regulations relating to the ?ve patients in question. Patients moved in and out of an intensive care setting based on their response to intravenous and oral therapy. Had the transplant team been trying to arti?cially advance the patient further up the list, the team would more likely have kept each of these patients in an intensive care environment continuously until a donor organ became available. In regard to Dr. Branislav Radovancevic, I first became acquainted with ?Brand" in 1985, as we were both engaged in leaninig the appropriate immunoregulation of pediatric heart tran5p1antation patients. Our acquaintance was limited largely to telephone conversations and conversations at scienti?c meetings. Over the years, I found Dr. Radovancevic to be a constant source of enlightenment with regard to transplant immunology and the management of the recipient?s immune reaponse. l?Vh?e,r as a foreign medical graduate, he never became licensed to practice medicine in the state of Texas, he did develop a remarkable expertise on the various immunoregulatory drugs that were being investigated and utilized during the era represented by this complaint. His work as a research associate, collecting, reducing, and publisl?ng data relating to heart transplantation, helped the international community of transplantation scientists and clinicians to manage their own recipients better. Over the years, I enjoyed watching him develop a 14 .15 3?12?2218 FROM LLUSM SURGERY CHAIR 989 558 ?1118 national and international reputation for expat-Ilse, both in the immunology of heart transplantation, and in the experimental use of circulatory assist devices, an expertise he developed. while working in the animal research laboratories in Houston. Branislav Radovancevic was a clinical and laboratory research associate under the direct supervision of Dr. 0. Howard Frazier. As such, I would characterize Dr. Radovancevic as a key investigative member of the heart transplant team at St. Luke?s Episcopal Hospital. Heart transplant teams usually consist of from 15-25 individuals, each with special expertise which applies to both potential recipients, and those who have had heart transplantation and are being followed afterwards. The team usually consists of physicians who are licensed surgeons or licensed physician-specialists in cardiology, infectious disease. hematochgy, nephrology, etc. In addition, the team includes immunologists (frequently with PhD?slicensed physicians, pharmacologists. social workers, coordinators, statisticians, and others. All contribute to patient welfare and outcome. Dr. Radovancevic?s role as a clinical investigator was in the area of tran5p1ant immunology and the application of mechanical circulatory support devices. Under Dr. Frazier-?5 supervision, it was Dr. Radovancevic?s job to advise and counsel the physician members of the tranSplant team in areas of his expertise. In addition, it was 15 .18 3?12?2218 FROM SURGERY CHAIR 939 558 11116 his responsibility to collect data, which when compiled, would help educate and strengthen the care of heart tranSplant patients worldwide. In reviewing the records of the ?ve patients identi?ed in this action, I could find no clear, direct evidence that Dr. Radovancevic engaged in the kind of independent patient care that might justi?ably be construed as the practice of medicine in the state of Texas. Indeed, the entire body of evidence contained in Plaintiff? Relator Joyce Riley?s complaint is Open to interpretation, it not speculation, derived from nursing and physician notes, and is largely circumstantial in nature. Of the hundreds of notes and Orders on the patients? charts, a scant handful (approximately 30) discovered by the Plaintiff?Relator made any direct or indirect reference to ?Brano? or Dr. Rado-vancexdc. It is not possible for me to believe that he was ?practicing medicine? with no more direct involvement in patient care than is evident in the records and documents that I reviewed. Rather, I believe Dr. Radovancevic acted appropriately as a research associate and consultant to licensed physician-members of the transplant team. My personal experience with Dr. Radovancevic suggests to me that he was a very bright, hard?working, and forthright individual who, knowing himself to be unlicensed to practice medicine in the state of Texas, would not Violate patient trust and con?dence by masquerading as a practicing physician. Having said that, Dr. Radovancevic?s opinion among the 16 .17 3-12?288 FROM LLUSM SURGERY CHAIR SE9 558 #1118 II. tran5plant team members was highly valued, and there is little doubt he took a personal interest in the progress and outcomes of these and other patients. Suggestions related to individual patient management which Dr. Radovancevic may have provided, were first filtered through the licensed physician team which discussed and either did or did not implement them. The structure of the team was designed to bene?t from each area of expertise, including Dr. Radovancevic?s. Final decisions and iznplementa?on of team member suggestions was accomplished by the licensed. physician-members of the team, including those in training. REVIEW OF SELECTED CASES A. Patient No. 1153455 Case Summary: Records reveal a male patient in his mid?40?s referred to St. Luke's Episcopal Hospital with a diagnosis of idiopathic dilated cardiornyopathy. He was initially evaluated for cardiac transplantation in October of 1989. He was found to meet criteria for cardiac transplantation and was registered with UNOS. During his period of waiting for a damn organ, he was readmitted to the hospital on several occasions with episodes of acute decompensation relating to his congestive heart failure and pre?lethal cardiac An automatic cardiac defibrillator was implanted in February of 1992. In 17 -18 3?12-288 FROM LLUSM SURGERY CHAIR 9919 558 4118 April of 1992, he underwent heterotOpic, or so-called piggyback, or tandem heart transplantation. This unusual form of cardiac transplantation is reserved for potential recipients with marginal native physiology or, as in this instance, when there is considerable concern about the donor organ. His donor heart had experienced ?ve hours of cold graft ischemic time? during an era when four hours was thought, to be the limit for viability. His initial progression was satisfactory, but he was readmitted in August of 1993 for cardiac cathetarization and biopsy during which time it was found that his native heart was essentially ?non-contractile," and he was living entirely off the heterotopically transplanted heart. He was readmitted a year later because of a number of quite alarming ?ndings of visceral failure, including liver failure that appeared to be unrelated to his medications. His medical issues were difficult to sort out, as his transplanted heterotopic heart seemed to functioning in a normal way. Nevertheless, this patient was failing rather rapidly. Eventually, it became apparent that the failure was due to his own dysfunctional 25 27 28 ?The time, during which, the heart has no blood supply of its own. Or, stated another way, the time from donor organ recovery to the time, toward the end of transplantation, when the heart graft circulation is reestablished. 18 .19 FROM LLUSM SURGERY CHAIR 989 558 A118 native heart, and he was listed for an additional transplant to remove and replace his native heart. The secondary orthotopic transplant was accomplished on November 9, 1994. His postoperative course following recovery was relatively unremarkable with the exception of an embolus (migrating blood clot) to his left leg in January of 1995. The embolus was removed by Dri Frazier, Plaintiff-Relator?s Complaints: Plaintiff alleges that the patient had two heterotopic transplants, that the patient had an arti?cial upgrade to intensive care in order to obtain a second heart transplant, that because this patient was able to ambulate and briefly visit with family in the hospital cafeteria, that he did not require intensive care surveillance, and that he was transplanted for the second time in order to fraudulently bill Medicare; this to gain compensation that Was not available with his ?rst transplant. In My Opinion: Based on review of the patient's records and the plaintiff?s complaint, it is my opinion that the plaintiff possessed little, if any, comprehension of the magnitude of this ?patient?s illness. Deepite the requirement for intensive care surveillance, activities Such as walking were vital to the prevention of complications, such as pulmonary andXor systemic embolization, and to his mental and 19 .29 FROM LLUSM SURGERY CHAIR 989 558 ?lls physical fitness level. I-Iis distressing post-transplant decline required the patient be under hospital surveillance and, at times, in the intensive care arena. In this extremely unusual case, the heart transplant team was able to identify the patient? 5 native heart as the source of his systemic failure, and the surgical team led by Dr. Frazier had the courage to reoperate and replace the patient?s native heart with a second transplant, after wl?ch his recovery to health Was largely unremarkable. This case is suf?ciently unusual and well-managed to be reportable in the scientific literature. I found nothing to support the plaintiff's complaints. Patient No. 0524725 Case Summary: This is a male patient who was admitted to the hospital on June 9, 1993 for a transplant workup. He presented with an 18?month history of heart-?related Echocardiography revealed severe global heart dysfunction. His disease supported a diagnosis of dilated, end?stage cardiomyopathy. He was admitted again in early August, 1993, for treatment of decompertsated congestive heart failure. He had been placed on the heart tran5plant list and was categorized as being in New York Heart Association classi?cation IV during this particular admission. Class IV means his shortness of 20 3?12?2ee dz57PM FROM SURGERY CHAIR 989 558 Ill 18 breath and other prevented his participating in even restricted activities of daily life. His heart was irregular, and he had at least one episode of pre-lethal ventricular tachycardia. He spent some time in the intensive care unit, where it became necessary to infuse heart stimulant, in the form of depamine, to restore a measure of his heart function. He did, indeed, improve and was discharged. He failed outpatient management, however, and was readmitted to the hospital, and was placed on intravenous heart stimulant once again on August 30, 1993. He remained in the hospital until October 8, 1993, where he spent time in both the intensive care unit and in the basic hospital ward while awaiting heart transplantation. The patient was transferred back and forth between ICU and the basic ?oor as his medications enabled a degree of recovery in his congestive heart failure The patient was ultimately discharged but, again, failed outpatient management and was readmitted on December 28, 1993 with worsening cengestive heart failure and deteriorating kidney function. He was again placed on intravenous heart stimulant, and he gradually regained a measure of cardiac function, allowing him to be both a suitable candidate for heart transplantation, and to be ambulatory. He was still being troubled by episodes of heart 2'1 22 23 24 25 26 27 FROM LLUSM SURGERY CHAIR 8E9 558 ?118 disturbance, which were controlled with medications. He gradually compensated for his heart failure such that he could be discharged on medical management beginning in February of 1994. He ultimately had successful heart transplantation in May of 1994. Plaintifvaelatofs Complaint: The major complaint regarding this patient had to do with the alleged artificial admission and unjusti?ed upgrade to intensive care during this patient?s pie-transplant management. In the plaintiff's view, this patient had not required a day of intensive care, despite time spent in the hospital and in intensive care. This appears to be based on the fact that the patient was largely ambulatory and was permitted to take short walks Within the hospital . and Without, and to have brief passes from the heapital. In My Opinion: The plaintiff, once again, fails to understand the capricious nature of end-stage congestive heart failure, and the magnitude of its many threats to patient survival. The plaintiff appears to be under a ndsconception that an intensive care unit is meant only for the management of acute catastrophic illness, not for the surveillance of life-threatening chronic illnesses such as end?stage heart failure. Despite every effort to control this patient?s heart failure without hospital?based intravenous drug support, it was 22 FROM LLUSM SURGERY CHAIR 9E9 558 ?118 clear that he could survive as an outpatient for only relatively short periods of time. He would then require readmission for more intense treatment, frequently in the intensive care setting. As his improved and he was able, it was only appropriate for him to take short walks with nurse?assistance, and even short passes, only to return to the intravenous heart stimulants that were so vital to his survival and quality of life. Hospital policy, in those days, typically required intensive care surveillance for any patient who required significant levels of intravenous heart stimulants. As the drug dosage was tapered or discontinued, indicating a measure of heart function recovery, the patient could reside on the basic care unit. Wherever he was, however, he was at risk for sudden death. His chances for resuscitation and recovery, should sudden death occur, were thought (by the transplant team) to be best within the hospital, and particularly within the intensive care setting. Hence, the transplant team correctly exercised a low threshold for placing him in these venues. Patient No. 1251716 Case Summary: This individual, with advanced coronary atherosclerosis and previous coronary bypass surgery, was first admitted to St. Luke?s Episcopal Hospital on March 12, 1993 for 23 .2d 32?1- 25 27 28 FROM LLUSM SURGERY CHAIR 9B9 558 A118 treatment of congestive heart failure. He responded to intravenous and oral cardiac medications and was discharged. His evaluation suggested end-stage cardiomyopathy and heart failure, for which he had been evaluated in October, 1992, as a potential candidate for heart transplantation. His transplant candidacy had initially remained indeterminate, although he was at this time said to have been activated on the St. Luke?s Episcopal Hospital heart transplant waiting list. Subsequentlythe hospital several times for treatment of his heart failure. He was then hospitalized in late 1993 at - Methodist Hospital in Lubbock, Texas (also a heart transplant center) for Ive-evaluation and management. Cardiac catheterization at that time revealed a progressive elevation in lung artery pressure and resistance, which, by then, made him unsuitable for conventional orthotopic heart transplantation. He was referred back to the care of the transplant team at St. Luke?s EpiscoPal Hospital where he was to be given consideration for a heterotopic transplant. After additional management of his heart failure, he was discharged on January 6, 1994, and was followed as an outpatient by Dr. Massin. When evaluated in the outpatient clinic on October 17, 1994 by Dr. Massin, the patient was found to be in profound congestive heart 24 FROM LLUSM SURGERY CHAIR 9&9 558 ?116 failure with shortness of breath, fatigue, and ?uid retention accounting for a 17-pound weight gain. He was admitted to St. Luke?s Episcopal Hospital mtensive care unit for aggressive treatment. Following a slow, but steady response to treatment, he was transferred to the ward on a smaller dose of intravenous heart stimulating drugs. These drugs were discontinued, except for one, a powerful agent called depamine, in early November. He was then provided with supportive therapies while additional information was acquired to determine if he might be a candidate for the rarely performed hete?rotopic transplantation. He was ultimately deemed unsuitable for transplantation because of advanced lung disease and was discharged to a nursing home in late December, 1994. This final decision was, indeed, painful for the patient and his family and for the transplant team. Nevertheless, he had, by then, experienced the benefits of savvy and deliberate opinions from two active transplant centers. The decision against tranSplantation was based on findings from both histihrtions. Plain?ff-Relator?s Complaint: The plaintiff suggests that because this patient had been evaluated at another transplant center in Texas where he was found to be unsuitable for conventional orthotopic heart transplantation, that his admission for reevaluation at St. Luke?s 25 3-12?2FROM LLUSM SURGERY CHAIR Sig 558 A115 Episcopal Hospital was improper and resulted in false and fraudulent billing to the federal government. The complaint suggests that because an occasional day or two transPired with no additional orders written that the entire hospitalization was unjusti?ed. In My Opinion: This patient fell victim to end-stage heart disease relatively early in the evolution of cardiac transplantation, and his disease process progressed incessantly. Criteria for orthotopic cardiac transplantation were still being modi?ed, such that potential recipients with marginal elevations in pulmonary pressure might still be considered for transplantation. Few worldwide institutions - had exPerience with heterotOpic transplantation, yet, ultimately, this Was the only possibility open to this patient, and it was a procedure being Spearheaded by the team in Houston. This potential recipient, in ?nal analysis, failed to meet acceptable criteria for either orthotopic or heterotopic transplantation. His disease process had progressed beyond reasonable hope for transplant success, and the team reluctantly, but declined. The patient was discharged. That this patient progressed in the hospital for the occasional day or two without new or interval orders, suggests nothing to me about his level of care, or his final outcome. This patient?s hospitalization was his last, best 26 P.27 5=oePM FROM LLUSM SURGERY CHAIR 999 558 ?118 chance to obtain therapy for his end?stage heart disease. That he was an unsuccessful candidate for transplantation is not an indictment?of his Support and evaluation during this or any other hospitalization. Whether or not this patient was a candidate for transplantation, cyclical hospital admissions for control of his end?stage heart failure were both necessary and appropriate. Case Summary: This is a male patient who had ektensive ischemic heart disease and had coronary revascularization in 1979 and again in 1987. He develoPed ischernic cardiomyopathy, and was admitted on October 11, 1994, with an acute myocardial infarction and congestive heart failure with persistent angina. The patient was evaluated and listed for transplantation. On November 18, 1994, he was transferred to the intensive care unit because of severe angina and a new myocardial infarction. On November 30, 1994, he developed cardiogenio shock and required an intra-aortic balloon purrip, which is an invasive mechanical circulatory support device used for short-term stabilization of heart failure patients. As the patients extreme heart failure gradually recovered somewhat, the balloon pump was removed. On December 22, 1994, he was fortunate enough to have orthotopic heart 27 .28 FRDM LLUSM SURGERY CHAIR 989 558 ?lls transplantation, during which he once again required the intra-aor?c balloon pump. His sternotomy incision was left Open to ensure that his transplanted heart had room to recover. The eternal incision was closed the next day and the balloon pump was removed two days later. He was separated from mechanical ventilation that same day. He then developed acute renal and liver failure, both of which gradually resolved. Unfortunately, his donor heart deve10ped complete electrical block, and he required a permanent dual-chamber pacemaker, which was inserted on January 4, 1995. He was discharged from the hospital on January 11, 1995. Plaintiff-Relator?s Complaint: Plaintlf?Relator Riley?s complaint, in this instance, does not take issue with this patients overall appropriateness and quality of care. In My Opinion: This patient? 5 care was exemplary. Patient No. 1108146 Case Summary: This is a female patient with dilated'cardiomyopathy and several co?morbidi?es, including obesity, diabetes mellitus, and endometriosis. She also appeared to have hypothyroidism and was under the care of an endocrinologist. She underwent a complete evaluation for transplantation in December of 1990. Her heart failure 28 .29 Ez?lpM Sincerely, FROM LLUSM SURGERY CHAIR 999 558 A118 and other issues were managed successfully as an outpatient, and she was admitted for heart transplanta?on on April 26, 1992. She had a long and dif?cult postoperative course, which included incessant cardiac graft rejection. She eventually required total radiation in an effort to control her intense immune response. Her recovery was complicated by collections of ?uid in the chest spaces around her long (pleural effusions), stomach ulceration, urinary tract infection, and diabetes. She did, however, ultimately recover. I Plaintiff-Relator?s Complaint: Plaintiff-Relator Riley? 3 complaint, in this instance, does not take issue with this patient's overall necessity and quality of care. In pinion: This patient's care was exemplary. 1f met-K Leonard L. Bailey, MD Distinguished Professor of Surgery Surgeon-in-Chief . Loma Linda University Children?s Hospital 29