Medical Liability and Health Care Law. Defense Practice Seminar Course Materials

Transcription

1 Medical Liability and Health Care Law Defense Practice Seminar Course Materials March 2013

2 All views, opinions and conclusions expressed are those of the authors and/or speakers, and do not necessarily reflect the opinion and/or policy of DRI and its leadership by DRI 55 West Monroe Street, Suite 2000 Chicago, Illinois All rights reserved. No part of this product may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying and recording, or by any information storage or retrieval system, without the express written permission of DRI unless such copying is expressly permitted by federal copyright law. Produced in the United States of America

3 Course Materials Table of Contents Evolution of Fetal Heart Rate Monitoring... 1 Charles W. Fisher What a Defense Lawyer Needs to Know About the Disclosure and Apology Movement in the Medical Malpractice Arena Doug Wojcieszak Litigating the Never Event Case Angela M. Agustin Fox MMSEA and Its Practical Considerations Examined in The Light of Day Vanetia K. Wetherspoon A New Day and a New Way: New Techniques in Preparing Providers for Deposition Michael A. Gross Impact of Obesity in Medical Outcomes and Lawsuits Dennis C. Smith, Jr., MD, FACS, FASMBS Techniques for Defending the Psychological Injury/Emotional Distress Case Glen S. Feinberg Defending High Risk and Catastrophic Neurosurgical Cases John E. Hall, Jr. The Second Chair at Trial Role, Responsibility and Reporting Annie J. Dike The Second Chair at Trial Role, Responsibility and Reporting Pamela S. Schremp Settling the High Stakes Case Amy Evans Pitfalls of the Well Baby Nursery: Procedures for Avoiding Disaster Bradley B. Stancombe, M.D.

4 Ethics and Professionalism for Litigators Walter W. Billy Bates State Medical Boards The New Adversary? Prevalent Disciplinary Actions Concerning Allopathic and Osteopathic Physicians Gregory A. Chaires and JoAnn M. Guerrero Characteristics of Physicians Referred for a Competence Assessment: A Comparison of State Medical Board and Hospital Referred Physicians Elizabeth J. Korinek, MPH Anatomy of the Spine: Back Surgery and Its Risks Samuel D. Hodge, Jr.

5 Evolution of Fetal Heart Rate Monitoring Charles W. Fisher Kitch Drutchas Wagner Valitutti & Sherbrook PC One Woodward Avenue Detroit, MI (313)

6 Charles W. Fisher co-heads the firm s birth trauma defense practice, specializing in the defense of cases involving all aspects of pregnancy and early neonatal malpractice claims. Mr. Fisher, along with others in the birth trauma practice, currently serves as national panel counsel to nationwide institutions, including Ascension Health, AIG Insurance Company, and the CNA Insurance Company. Mr. Fisher is also a consultant on OB protocols for hospitals and health systems throughout the state of Michigan. As part of his practice, Mr. Fisher frequently lectures to physicians and hospital executives across the country on various birth trauma defense topics. He is licensed to practice law in Michigan and Ohio, as well as the U.S. District Court of Eastern Michigan. Mr. Fisher was named a Michigan Super Lawyer in Only five percent of the attorneys in the state are named Super Lawyers and in 2010, he was recognized as one of the Top 100 Lawyers in the State of Michigan. Mr. Fisher is AV Peer Review Rated by LexisNexis/Martindale- Hubbell. The AV Peer Review rating is the highest rating allowed. It attests to a lawyer s legal ability and professional ethics, and reflects the confidential opinions of the Bar and the Judiciary. Mr. Fisher received his J.D. from the Detroit College of Law, where he graduated summa cum laude and first in his class. He also earned a B.A. and M.A. with honors in Music Education from the University of Michigan. Prior to attending law school, Mr. Fisher worked in the field of education, teaching music.

7 Evolution of Fetal Heart Rate Monitoring Table of Contents I. Original Concepts...6 II NIH Consensus and Post NIH Recommendations...7 III. NIH in IV. Has Fetal Monitoring Made a Difference?...10 V. Final Summation...11 Evolution of Fetal Heart Rate Monitoring Fisher 3

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9 Evolution of Fetal Heart Rate Monitoring Historical Overview In the late 1960s and early 1970s, fetal heart rate monitoring began being introduced to hospital wide systems. By the middle to late 1970s, most hospitals were using electronic fetal heart rate monitoring. The original goal of the fetal heart rate monitor was to detect hypoxia early, provide an opportunity for intervention, and prevent death or neurological injury. This ideal was an objective but in fact was not proven at that time through any scientific research. When one reviews early writings on electronic fetal monitoring, there were several assumptions made. The first assumption was that the vast majority of cerebral palsy occurred during labor and delivery from asphyxia or difficult deliveries. The second assumption was that the event would transpire over a period of time often referred to as partial prolonged hypoxia, and that there would be an opportunity for intervention. A third component that was assumed is that the interpretation of the fetal monitor would be uniform among doctors. A fourth factor assumed was that various patterns on the monitor strip would correlate well with fetal acidosis. Early on, these assumptions were critical to the concept that fetal monitoring was going to prevent death or neurological injury, including cerebral palsy. However, the above stated concepts had never actually been proven, or even tested. The majority of cerebral palsy is now known to occur before labor and delivery, and may produce abnormalities on the monitor strip suggesting that damage has already occurred. In addition, it appears as though instead of partial prolonged hypoxia being a cause of neurological injury in labor and delivery, acute near total events, such as cord prolapse, uterine rupture and abruption are more likely events to produce brain damage in labor and delivery when it does occur. Because of this, one questions the ability to diagnose such an event, make a decision that there isn t going to be recovery on the fetal monitor strip from the sentinel event, and order/perform a cesarean section before damage occurs. Thus, the concepts upon which electronic fetal monitoring s use were based actually had never been proven before the universal use of it became endemic to most hospitals. It is clear that a uniform method of interpretation, agreement and consensus that is, as to what patterns correlated with significant acidosis and required emergency cesarean section was not developed then and possibly remains undeveloped today (except in a few end spectrum patterns). One of the major advantages of using electronic fetal monitoring is that one to one nursing would become unnecessary, and in the sense that the hospitals could save money on nursing staff, it seemed a valuable investment. Likewise, because of the believed concept that it would help babies, it also, combined with the reduction in costs for personnel, was readily adopted by institutions. What wasn t expected, was the eventual plethora of lawsuits in which hospitals and doctors were spending extraordinary amounts of money on litigation costs, indemnification, and the rising cost of insurance. Clark, et al, published an article wherein he pointed out that elective cesarean section on all patients would be less costly than submitting patients to labor and delivery and having a few brain damaged baby lawsuits result from deliveries at the hospital. In the meantime, as the cesarean section rate went from about 3 to 4 percent in the United States to about 30 to 40 percent at some institutions after electronic monitoring was introduced, it was noted that in Dublin, Ireland, the c-section rate stayed at 3 to 4 percent. Outcomes of babies remained identical between the two countries, which began to be a marker of such distinction that the value of electronic monitoring was questioned by a number of various authors. From that point until today, literally hundreds of articles have Evolution of Fetal Heart Rate Monitoring Fisher 5

10 been written on the methods of interpretation, indications for c-section, results of such interventions, and the overall rate of cerebral palsy in the United State as correlated to electronic monitoring. Were it not for the intersection of medicine and lawsuits at great monetary exposure, the study of the evolution of fetal monitoring would be one of the most intriguing historical events in medicine. It leaves one questioning, as did Clark later on, why a device that appears to be about 99 percent wrong is even being used in medicine? (See Clark s article on Demographic Trends cited in the slide presentation). Below are three separate time frame explorations. They involve the original evolution and science behind fetal monitoring, matters that occurred after the 1997 NIH conference on fetal monitoring, and current information and recommendations that appeared in 2008 from the second NIH conference. Finally, there will be a brief discussion on whether electronic fetal monitoring is efficacious. There may be some rare instances in which the electronic fetal monitor actually has prevented a poor outcome. However, the fact that cerebral palsy has not been reduced at all, suggests that the rare and exceptional instance where a monitor has saved a baby might be so small and sparse, that it would be difficult if not impossible to say that there is scientific evidence that electronic fetal monitoring during labor and delivery prevents cerebral palsy I. Original Concepts Edward Hon, in 1969, wrote the Atlas of Fetal Monitoring. In his monograph, he made it clear that there are essentially two patterns that will occur during labor when there is developing hypoxia. Those two patterns that he listed were either prolonged variable decelerations or late decelerations. This is not difficult to understand, because labor presents a unique event that involves periodic stress on the baby as a test of the intrauterine environment. There are two basic reasons why you could develop hypoxia during labor, one being a cord accident, the other being a placental insufficiency problem. In both those situations, the first sign you would expect to see is a deceleration pattern, producing either variable decelerations of a significant or severe type, or late decelerations. Although it is common in lawsuits to claim that other abnormalities (decreased variability, tachycardia, fewer accelerations) are evidences of hypoxia, this does not fit into any of the original scientific investigator s concepts. From Hon, to Parer, to Schifrin, to Paul, to Freeman, and contained in a number of textbooks over the years, the most crucial element that you must have before any hypoxia can be declared, is a pattern of decelerations (or simply an outright sudden bradycardia). In fact, the electronic fetal monitor literature, as it originally was presented, contained no evidence that patterns in labor other than decelerations should be interpreted as hypoxia. Over a period of years, another concept was explored in detail and that was the significance of variability. Decelerations with progressive loss of variability would be, and is accepted as one of the first indications that the baby is starting to develop metabolic acidosis. It was found by Dr. Hon, and agreed to by other investigators, that it is not unusual for many babies to normally have some degree of hypoxia during labor and delivery because it is stressful. This stress was exhibited by decelerations, but did not necessarily represent any significant metabolic acidosis. Furthermore, the ph actually normally drops during labor and delivery. Thus, there is some mild hypoxia and some mild metabolic acidosis that occurs in most deliveries. It is for this reason that researchers began looking very carefully at the interpretation of decelerations in the context of baseline variability. Many, many cesarean sections were being done yet there was no improvement in overall outcome. In other words, doctors were regularly doing cesarean sections simply on the basis of decelerations without any acidosis. Freeman s text indicated that the most common reason for unnecessary cesarean sections was vari- 6 Medical Liability and Health Care Law March 2013

11 able decelerations as the vast majority of those decelerations were of a benign nature, not reflecting any significant hypoxia or acidosis. Eventually, and as followed up by Acog Bulletins from 1977 onward, the concept became stronger and stronger about the requirement of decelerations to prove hypoxia, and the importance of variability in evaluating a deceleration pattern. In Acog Bulletin #207, it was specifically indicated that decreased variability without decelerations is not likely to be due to hypoxia, thus, ensuring and endorsing the concept over the years that had developed the first sign of possible hypoxia is the development of a deceleration pattern, however, as long as the variability of the strip was present you had reassurance that this was not acidosis. Importantly, physicians thought that this would decrease the incidence of cesarean section, and more importantly, provide real evidence that cesarean section was making a difference in specific cases where decelerations with absent variability existed. However, the continued investigation of causation, comparing rates of cerebral palsy to fetal monitoring and crash c-section, repeatedly proved that the rate was not falling and fetal monitoring was not producing what they expected. Because of the many perceived issues in fetal monitor interpretation and efficacy, including lack of uniformity in definitions or agreement as to management, and the obvious concern about the high cesarean section rate without evidence of improvement, there was a consensus meeting in 1997 at the NIH to try to find some solutions. II NIH Consensus and Post NIH Recommendations In 1997, although it was intended to be a consensus meeting, there actually was very little consensus. The gurus of fetal monitoring all agreed on what was a completely normal strip. Secondly, they agreed that when you have a deceleration pattern with completely absent variability, this is ominous and delivery needs to be implemented fairly expeditiously. However, the major gap in agreement was virtually everything that existed outside of these two categories, and this included the vast majority of monitor strips, many of which had abnormalities but which were not specific enough for the physicians to reach a consensus. Thus, they indicated that those patterns and their management were controversial and that more investigation was needed. These are the patterns however that many lawsuits have been based on. The consensus group set forth a number of definitions hoping that there would be more uniform interpretation for further study. If there was uniform identification, the thought was that they could then determine efficacy. Post 1997 NIH consensus, Acog Bulletin # was produced. What is intriguing in that bulletin is even after the definitions in 1997, panels of experts were given the same monitor strip and still disagreed on interpretation. In only 22 percent was there agreement as to the interpretation. Two months later, the same physicians looked at the same strips, and 21 percent read the fetal heart rate pattern differently from their original reading. They also found that knowing the outcome definitely affected the reading of the strip, and they stated that the reading therefore was not reliable. By 2005, a number of studies cited in this bulletin revealed that the incidence of cerebral palsy still had not been reduced. In the meantime, the often used term of fetal distress was abandoned for what probably is a more nebulous concept, non-reassuring. Non-reassuring was not well defined as a consensus, and depending upon which author you read, the definitions differed, or there were no real definitions. This provided fertile ground, of course, for lawsuits in which plaintiffs experts would find something non-reassuring. It was an easy retrospective argument and continues to be an easy argument that an interpretation was misread because the baby ends up with brain damage. The lack of a unified and agreed upon definition Evolution of Fetal Heart Rate Monitoring Fisher 7

12 for non-reassuring was a major omission especially in the context of the NIH publication and consensus meeting in The NIH made it very clear there was absolutely no agreement on patterns between the normal and completely ominous patterns, however, one could regularly categorize many of the in between patterns as non-reassuring which was often done in medical records as well. This was used to great advantage by plaintiffs in lawsuits. In other words, it doesn t sound very logical to define something as non-reassuring and then fail to perform a c-section. There are quite a number of variant patterns that are non-reassuring (i.e. mild variable decelerations) which are in-between patterns but require no cesarean section. In one effort to help clarify the patterns on monitor strips, fetal pulse oximetry was introduced. What was then proven is that in some of the most ominous looking patterns visually, the baby was not acidotic or hypoxic at all, and the fetal pulse oximetry proved that this was true. Unfortunately, physicians still became concerned when seeing some of these patterns, and did c-sections anyway. This eventually resulted in an abandonment of the fetal pulse oximetry because the c-section rate was not decreasing. In reality however, this was unfortunate in the medical/legal sense. If you did continue labor with a fetal pulse ox on, you had unequivocal evidence that hypoxia was not present even with decelerations. It would have provided a significant piece of evidence in the lawsuit that it was reasonable to continue labor in the face of abnormalities that might be called non-reassuring on a monitor stip. In 2008, the NIH held its second conference on fetal heart rate monitoring to try and reach a consensus again. In addition, there was another attempt to define and identify patterns specifically for more accurate study group comparisons. This NIH meeting was followed by another ACOG bulletin in 2009, Number 106 which is one of the current bulletins in effect. III. NIH in 2008 The NIH meeting in 2008 involved new terminology and redefined Categories of fetal monitoring patterns. By 2008, a number of additional articles had appeared regarding electronic monitoring and lack of efficacy. In fact, one of the articles was specifically entitled, Is Fetal Monitoring Salvageable? This of course was an interesting commentary on the fact that the original concepts of what fetal monitoring were supposed to be doing did not seem to be evidencing themselves, as the cerebral palsy rate continued to be unchanged and in fact was on the rise in both preterm and term infants. In 2008, the NIH defined three categories. A close look at the three categories in 2008 reveals that they directly resemble the same thing they found in The categories as define, I, II, III related to the normal strip (I), the completely ominous strip (III), and the indeterminate Category II strip which contained everything else. The statements in the NIH indicated that with Category II, no correlation had been shown yet with fetal acidosis or poor outcomes and therefore you could continue to watch and monitor patterns in Category II. It was appropriate at this time that the words non-reassuring were left out of the NIH and the eventual ACOG bulletin, and instead are more definitive identifications of patterns that fit into Category I, II and III were provided. Irrespective of the medical propriety of doing this, the medical/legal consequences was that for the first time, defendants in a lawsuit could identify and slot the abnormal patterns into either Category II or Category III. If it was Category II it was a good defense that cesarean section was not required at that point. In 2009, ACOG published the bulletin 106. The authors of the ACOG bulletin interestingly added something different than the NIH 2008 paper had stated. In ACOG 106, the management protocol for Category II was included as though it was Category III. In other words, the bulletin itself includes management of Category II and Category III together making no distinction between the two. Therefore, the management 8 Medical Liability and Health Care Law March 2013

13 distinctions made in the NIH 2008 were being changed somewhat by the ACOG bulletin in There is no explanation for this in the bulletin. Following up quickly after 2009 s Bulletin, ACOG published another bulletin on management of fetal heart rate patterns just a year later in 2010 bulletin 116. In this author s humble opinion, there were different things that it contained in the management section that heretofore had never been included or incorporated. For instance, tachycardia with decreased variability was clearly a Category II pattern as previously defined. However, the bulletin went on to indicate that with intrauterine resuscitation, if you could not improve the pattern, you must consider delivery (easily interpreted by Plaintiffs in a medical legal context as requiring a stat cesarean section). Thus, in 2010, one begins to question whether or not the recommendations as they exist in the 2010 bulletin are based upon scientific principles. Recall that the original developers of the electronic fetal monitoring clearly indicated, and repeatedly indicated, that the first sign of hypoxia in labor and delivery is a pattern of decelerations (not tachycardia, not decreased variability, and not absent accelerations). In fact, prior authors including Gabbe s textbook (Thomas Garite s chapter) made it very clear that those non deceleration patterns should not be considered signs of hypoxia in labor and delivery because they were not preceded by decelerations. In 2010, Acog Bulletin #116, the management protocol that could lead you to a possible emergency cesarean section does not even require a pattern of decelerations (you could just have decreased variability that doesn t improve, tachycardia with decreased variability that doesn t improve, or even no accelerations with decreased variability without improvement, and no decelerations at all in any of these situations). Thus, in 2010, one asks the question, where is the science to back up these recommendations that aren t just different than previous recommendations but almost the opposite? Not only has there been an absence of medical/scientific support for defining these non-decelerations patterns as hypoxia and acidosis in labor, perhaps even more importantly, there isn t a single study whatsoever that shows intervening with a nondeceleration pattern produces a different outcome. C-section is not without risk. Note that a mother whose baby has a tachycardia has maternal risk, including possible spread of infection if the tachycardia is caused by chorioamnionitis. Without any proven evidence that these patterns are hypoxic or acidotic, or causal on an acute preventable basis, Acog 116 seems to indicate that a c-section be done. Further changes developing over the years since 2008 to the present have been remarkable in terms of different authors recommending different ways to interpret monitor strips. We have authors recommending a whole different category system, or multiple other categories. We have authors recommending a colorcoding system for categories that is actually quite complex. We have authors that have suggested that the most important finding on electronic monitor strip is not the persistence of decelerations, but the squared area of the deceleration. We have authors that have looked at adjunct devices such as a fetal EKG to try and obtain better results. We have authors that have now basically suggested that with Category II patterns you have to call the surgical crew to be ready just in case, when in fact that would mean probably calling the surgical crew on about 90 percent of all cases in labor. Finally what is quite unique is the recent article by Shawn Blackwell who may have identified the most problematic issue of all. That is, he pointed out that there was very poor agreement, or inadequate agreement between obstetricians as to whether or not variability was absent, or still present, although diminished. This of course is the most crucial distinguishing factor between Category II and Category III and the distinguishing factor between the lack of metabolic acidosis and the presence of a dangerous acidosis. Such a study Evolution of Fetal Heart Rate Monitoring Fisher 9

14 is condemning of the ability of intra-observers to actually detect the most crucial point of the pattern that would distinguish continuing labor versus cesarean section. Why so many different authors suggesting so many different changes and ideas? There can only be two reasons. Number one, the interpretation of the strip is so subjective, that it is given to different interpretations except in the most extreme cases at either end. Thus it makes it extraordinarily unfair to any obstetrician to be criticized for interpretation on patterns that are considered the in between or indeterminate patterns. There simply is no real consensus on the interpretation of the vast majority of FHT patterns. Secondarily, it raises the suspicion that electronic fetal monitoring is cannot prevent poor neurological outcomes, either because they are already present before labor, or because the event is so acute that allowing time for interpretation of the strip, ordering a cesarean section and performing it, is not going to prevent the acute injury. It would seem that one or both of these concepts are true, and impact the ability of the health care provider to make a difference. As a final thought, it must be remembered that decelerations in labor are common, variable decelerations occur probably more than 80 percent of the time. The concept of the boy who cried wolf, certainly enters the thinking process here and the realities of fetal monitoring. Health care provides see abnormal patterns all the time with good outcomes! The concept that is completely abandoned in trial when you are simply focusing on one baby, is the near universal fact that vast majority of labors have decels, even significant ones, and yet outcomes are rarely abnormal. It was pointed out by Karen Nelson, even in those cases where there are late decelerations, about 98 percent of the babies turn out completely normal. If you are watching a test that 98 percent of the time is completely wrong, you become somewhat numbed to these patterns which are particularly frequent in a huge percentage of the laboring patients. Asking the clinician to distinguish the one or two percent (per Nelson) of those babies that would end up with a poor outcome on the basis of a pattern that is so often wrong is unfair to any clinician. IV. Has Fetal Monitoring Made a Difference? There have been many efforts over the years to explain away the reason why the cesarean section rate has not produced a reduction in cerebral palsy. There are regular theories posited by plaintiff s experts when they are confronted with this issue, all of which have been basically discredited. Often we heard that because more premature babies were being saved, the rate of cerebral palsy would not go down even though we are making a difference in the term infants. This has been disproven and particularly so by the CDC that divided up the rate of cerebral palsy in term and preterm babies showing that in term infants, the rate is continually gone up over the past 10 years. Another regular theory so posited by plaintiff s experts was that the number of babies that actually get brain damage in labor from hypoxia is small that it is impossible to do a study. Of course, if that is true, where is any scientific support that you are making a difference if you can t even study it? remember that Daubert is the plaintiff s burden of proof. However, this theory was also disproven by the Clark and Hankins article in the American Journal of Obstetrics and Gynecology in In an extraordinary article using statistical analysis they proved that this plaintiff theory was incorrect, and that you can detect differences that are this small. (a very complex article but very detailed). One of the points made in the Clark and Hankins article was that thirdworld countries don t have any worse cerebral palsy rates than we do, and they don t even do cesarean sections. A number of articles have addressed this whole issue of causal effect leading to a meta-analysis in the Cochran Database (updated in 2007) stating that there was no difference in the death rate or the cerebral 10 Medical Liability and Health Care Law March 2013

15 palsy rate with electronic monitoring and emergency c-section. The only difference that they could find with electronic monitoring and a cesarean section was reduced seizures in the nursery. Interestingly, the Cochran Database suggested that before doing a cesarean section, you should obtain informed consent which would include the fact that even if they do an emergency cesarean section, science has not shown that it prevents any injury. This is quite a reverse concept from what was previously suggested on causal prevention when fetal monitoring was first introduced. We also often hear the construct that there s a thirty minute standard of care for doing crash cesarean sections from decision to incision, suggesting that this would be preventative of insult. However, no one really knows how this time frame actually came about other than possibly from Dr. Hon s original publications (or others) that suggested he felt babies could withstand fetal hypoxia for about 30 minutes. Thus the concept developed that if you do the cesarean section in 30 minutes or less, you will prevent damage - another claim that has never been scientifically proven. Intriguingly, articles published by Murphy, et al and Ball, et al in February and August of 2007 showed that expediting delivery with operative vaginal (vacuum or forceps) in about 15 minutes produced no difference in outcomes as compared to cesarean sections done in about 30 minutes. Ball s data also compared operative vaginal delivery alone (vacuum/forceps) with failed operative delivery and cesarean section, as compared to just going to a cesarean section. There were no differences in outcomes. Therefore, we now have the scientific situation where we have not shown any proven evidence that we are reducing the incidence of cerebral palsy, and in comparing the deliveries done in 15 minutes to those done at 30 or 40 minutes, there is no difference in outcome. This seems to support the belief that the outcomes for whatever reasons are not being affected by emergent physician intervention. Does an acute injurious sentinel event occurring in labor happen so fast that we really can t diagnose it and do a c-section fast enough to prevent harm? In medicine, management should be based upon proven scientific methods and knowledge. Likewise in the court of law, the same equivalent standard should apply. From a purely statistical standpoint, there have been hundreds and hundreds of lawsuits that have been asserted and collected on based on a claim that the electronic monitor showed fetal hypoxia that required a crash cesarean section. How interesting it is to then have a plaintiff s expert proclaim that there aren t enough events of HIE during labor and delivery to even study the causation issue, while they go on to testify in their hundredth lawsuit that a c-section could have prevented injury. V. Final Summation The question when do I do a cesarean section? has really not been carefully answered in medicine and it is remains extraordinarily judgmental. Basing those decisions on a monitor strip that even now produces multiple articles on how to interpret it and different ways to interpret it, has to be discouraging to obstetricians. The current ACOG 116, has seemingly gone beyond the original medical science. Providing a nebulous exculpatory phrase that you may consider cesarean section in Acog 116, will mean (in a lawsuit) that you must consider and do a cesarean section. Concepts originating from Dr. Hon s 1969 Introduction to Fetal Monitoring have seemingly taken a backseat to extraordinarily complex and confusing regimens, codes, colors etc. In reality, most nurses and doctors will have difficulty following some of the current suggestions, especially in light of the fact that Category II strips pre-dominate labors with a variety of different abnormalities. In watching the evolution of the science of electronic fetal monitoring since its introduction in the late 60 s and 70 s, it is clear that it is not working in the way that was expected. It is and was self-evident that Evolution of Fetal Heart Rate Monitoring Fisher 11

16 there was a major problem with the interpretation of the fetal monitor given the incredible number of articles that have been written to address this. Will there ever be a uniform accepted method of interpretation? Legally, causation issues should be a part of the defense in all of these cases, including engaging Daubert challenges on these very issues. These issues must be part of the defense s preparation of their own fact witnesses as well. Defendants should not give away causation by ill prepared testimony. Medically, causation should be carefully studied, not presumed. Acog needs to take a significant look at this issue as being important as, or even more important than creating another interpretation and management bulletin. 12 Medical Liability and Health Care Law March 2013

17 What a Defense Lawyer Needs to Know About the Disclosure and Apology Movement in the Medical Malpractice Arena Doug Wojcieszak Sorry Works! PO Box 531 Glen Carbon, IL (618) [email protected]

18 Doug Wojcieszak is a disclosure training consultant who has taught and consulted thousands of healthcare, insurance, and legal professionals on disclosure principals. Mr. Wojcieszak has authored several books, including the best-selling Sorry Works! 2.0 Book and the recently released Sorry Works! UP Book. Mr. Wojcieszak and Sorry Works! recently launched an educational campaign to teach patients and families about disclosure, which includes a new book entitled, Did the Doctor Make a Mistake?

19 What a Defense Lawyer Needs to Know About the Disclosure and Apology Movement in the Medical Malpractice Arena Table of Contents I. Stop Pulling Back the Reins Post-Event...18 II. Empathy vs. Apology...18 III. Training Doctors, Nurses, and Other Staff on Empathy...19 IV. Empathy After Little, Everyday Moments...21 V. Run a Credible Review...21 VI. Compensation for Errors...22 VII. Hitting the Reset Button with the Plaintiffs Bar...22 VIII. Educating Patients and Families...23 IX. Your Practice, Your Firm...23 What a Defense Lawyer Needs to Know About the Disclosure and... Wojcieszak 15

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21 What a Defense Lawyers Needs to Know About the Disclosure and Apology Movement in the Medical Malpractice Arena My family has lived through medical malpractice twice, including the death of my brother Jim at age 39 in 1998 from a misdiagnosed heart attack. Jim entered a Cincinnati, OH hospital at 2am complaining of severe chest, shoulder, neck and stomach pains all the classic signs of a heart attack. However, because of Jim s physical stature (he looked like a football player) and his age (39 years) the doctors assumed he had a stomach condition. They gave him an ulcer cocktail and sent him home at 5am without drawing his blood. A few hours later my brother was still in excruciating pain and starting to pass out, so my parents brought him back to the same hospital. By midmorning the staff finally drew Jim s blood, the enzyme was in the blood showing damage to the cardiac muscles, and they admitted Jim to the ICU, which is where the holes of the Swiss cheese started to line up. The computer monitor over Jim s ICU bed read Ray Wojcieszak. Who s Ray? That s my Dad. This was very significant because my Dad had had a stress test conducted in the same hospital a few prior to my brother s passing. My Dad at that time was in his mid-sixties and passed the test with flying colors. No blockage. In fact, the cardiologist wrote in the chart that dad had the heart of a 30-year old man. Yet, a few months down the road there was my Dad looking at a computer monitor with his name on it but his oldest son Jim was in the bed. Dad alerted the physicians to the mistaken identity, but they wanted to argue with Dad about who was who! Dad had to produce driver s licenses to prove identities, and they eventually changed the name on the computer monitor to read Jim, but not before they were using my Dad s charts to diagnose Jim with a bacterial infection of the heart. For two days they plugged Jim full of antibiotics, but, Jim actually had four blocked arteries. By the time the doctors discovered their mistakes it was too late, and Jim died during emergency open heart surgery. A cover-up quickly followed and we had to file a lawsuit, leading to a settlement two years later but at the time no apology, admission of fault, or explanation of what went so terribly wrong. We never heard from the doctors or nurses involved in Jim s care. I used Jim s story to launch Sorry Works! ( which has become the nation s leading training organization dedicated to teaching healthcare, insurance, and legal professionals how to disclose and (when necessary) apologize and fairly compensate after something goes wrong in a medical setting. Apologies and fair compensation not only reduce the need for lawsuits, but they also help doctors learn from their mistakes and make medicine safer. Once controversial, disclosure is now readily accepted in medical and insurance circles. Though many doctors and nurses still need disclosure training, countless people (patients, families, caregivers) have already benefited from disclosure. Sorry does work! When I wrote the first edition of the Sorry Works! Book back in 2007 with two medical malpractice defense lawyers as co-authors, I remember my Father asking me, Defense lawyers?! Why would defense lawyers support disclosure? Are you sure selected the right co-authors??! I calmed my Father and assured him I had made a wise choice in co-authors, because these medical malpractice defense attorneys truly understood (and still understand today!) what disclosure is all about. Moreover, many more defense lawyers are learning the value of disclosure how it can help all parties in an adverse event receive the healing and closure they need in an ethical and fair-minded fashion. Disclosure should not be anathema to defense counsel. Quite the contrary, disclosure is based on solid defense principles, and while it represents a new way of doing business, it is also a better way of doing business for all parties. What a Defense Lawyer Needs to Know About the Disclosure and... Wojcieszak 17

22 In tackling this article, I decided to craft a document that will allow me to share my thoughts on what every defense lawyer should understand about disclosure call it Disclosure 101 and do so in a way that is conversational and engaging. This will probably be a little different style and format than what you are used to seeing in an article written for attorneys. It s written from the patient and family perspective and voice, which is actually the most important perspective in the med-mal crisis. Learn to deal with us effectively post-event and the need for litigation is reduced dramatically. Let s begin. I. Stop Pulling Back the Reins Post-Event Two years ago I conducted a seminar for the Indiana Defense Counsel Association, and I was joined on a panel by two Indiana defense lawyers. The lawyer to my right was skeptical about disclosure, and provided me and the audience with a visual representation of her common practice of pulling back the reins after something goes wrong in a hospital or practice. While continuing to demonstrate a very strong and aggressive rein-pulling motion, the lawyer described to the audience why she wasn t comfortable with doctors and nurses talking post-event, how she couldn t control the conversations, and how she was worried about the creation of harmful evidence that she wouldn t be able to defend in court. Before responding I couldn t help but think, Pull those reins back any harder and you re likely to snap off the doctor s head! Seriously, though, defense lawyers have to stop pulling back the reins post-event. Yes, you may prevent the creation of some harmful evidence post-event, but the process itself stokes anger with patients and families (which is a leading driver of litigation) and creates other harmful evidence that can be used by personal injury lawyers to inflame the judge and jury. What I am talking about? Every time the doctor turns his back every time the nurses goes stone cold every time the risk manager or hospital CEO fails to return a phone call and so on and so on is powerful evidence for a lawsuit. Even if the care was good, your client looks guilty, so says 12 lay-people sitting in the jury box. Pulling back the reins is no longer an option post-event. As your clients embrace disclosure, let them empathize and stay connected post-event (covered below). Moreover, resist the temptation to put the brakes on the disclosure program when a doctor or nurses does make a misstep in their communications post-event (because it will happen). Instead, use these slips up to emphasize the need for more training of doctors and nurses in post-event discussions with patients and families. Furthermore, always keep your eye on the bigger picture while the occasional verbal slip post-event might make your job more difficult with a few cases, how many cases are being avoided altogether because doctors and nurses are empathizing and staying connected post-event? The evidence from across the country strongly suggests the latter is happening far more often with disclosure than the former. II. Empathy vs. Apology Doctors and nurses have historically been told never to say sorry, and they often credit this advice to defense counsel. The defense lawyers specifically instructed us never to say sorry, because that s admitting fault and we ll get the hospital sued, is what many caregivers have told me in my travels. It s a new day, and that new day starts by understanding the difference between empathy and apology and making sure caregivers are up to speed. Empathy = I m sorry this happened I feel bad for you. We will conduct a review to determine what happened. 18 Medical Liability and Health Care Law March 2013

23 Apology = I m sorry this mistake occurred.it s all my fault. We will be offering you compensation. Both phrases use the word sorry, but one is about emotions and staying connected (empathy), while the other is about admitting fault and making amends (apology). We tell physicians and nurses to empathize post-event, and only empathize, even if they think a mistake happened. We apologize only after a comprehensive review has proven a mistake. Empathy is appropriate 100 percent of the time post-event it s always OK to say sorry. When we train our doctors and nurses about using empathy (more below), and even script them we help them remain human post-event. We help them stay engaged with patients and families and preserve relationships, even after major adverse involving crippling injuries or even death. Talk to enough defense lawyers and plaintiffs lawyers (as I have), and most will state one of the chief reasons people file medical malpractice lawsuits is because no one said sorry. Many litigants often say it all would have been different if the doctor, who they really liked, hadn t run away and refused to communicate. Empathy is the key to post-event communications. III. Training Doctors, Nurses, and Other Staff on Empathy Doctors and nurses need to be trained how to empathize. They need to see and hear what empathy looks like, and your client organizations have to invest the time and energy to ensure that current staff and new hires down the road understand and embrace empathy. If empathy stops just one lawsuit, your client s investment is more than paid for. What follows is the sample empathy script we use to train doctors and nurses: Mrs. Smith, the operation is over and I know you were looking forward to taking your Mom home in a few days..you have the big birthday party with the grandkids this coming weekend. But, the surgery did not turn out as we expected, and your Mom is in the Intensive Care Unit, or ICU. I am so sorry this happened. I can only imagine how upsetting this must be for you. Please know we are beginning a review to learn how this happened, and we want to meet with you tomorrow afternoon at 3pm to discuss our progress. Please understand your mom is receiving the best care possible, and we are going to keep you updated on her progress. In the meantime, is there anything I can do for you or your family? Food or transportation? Help making phone calls? Do you need a minister or counselor? Here is my business card.the number on the card is my cell phone, and you are welcome to call me anytime. Again, I m sorry this happened, but we will get through this together. Who is providing this empathy? I d like to have the doctor or doctors who were involved in the care to be speaking with the family. That s a perfect situation but not every situation is perfect. Maybe the doctor is a bigger basket case than the family, or a lousy communicator, or a great communicator but the family is so angry that putting the doctor in the room would be a mistake. So, maybe we send in the physician s partner, or maybe a nurse who has a great relationship with the family, or maybe the head of risk or someone else from c-suite. Every case is unique, and every patient, resident, or family is different you have to know your people (including the patient/family) and act accordingly. Also, be sure to send two people from your side so there is a witness. Next, let s analyze that quote..what was said, and not said? What was said: What a Defense Lawyer Needs to Know About the Disclosure and... Wojcieszak 19

24 Sorry: Remember, absence of sorry is a leading drive of med-mal lawsuits. No problem here! Personalized: We talked about the birthday party with the grandkids. By personalizing a statement, your client shows a family or a patient they are not a number, which further helps in recovering the relationship. No mush statements: Disclosure organizations get into trouble when they offer mush statement such as we ll get back to you or talk to you next week. Patients and families are traumatized post-event, and the last thing they need is more uncertainty. Your client needs to provide date/ time specific statements post-event, and follow through. Even if your clients have nothing new to report, they can at least touch base and keep rebuilding the relationship. Customer service elements: Little things like food, transportation, phone calls, offering a business card with cell phone number, etc. show your clients care, which is what empathy is all about! What was NOT said: No apology, no pre-mature admissions of fault: Even if your client thinks a mistake occurred, admission of fault is generally not wise in the immediate aftermath of an event, because hunches are often not correct. And it s nearly impossible to take back an admission of fault it looks like a massive cover up and a lawsuit will surely follow. No jousting or speculation: Your client needs to stay in the empathy zone don t offer up conjecture or things you don t know to be 100% true even when pushed by family members! because that causes trouble for everyone, including the patient and family. Simply say you are sorry this happened and take care of immediate needs. Remember Setting and Body Language! How your client says it is just as important as what they say. They should look for a quiet, confidential setting free of distractions, including your client s smartphone or pager. Tell your client to sit down, learn forward, look the patient or family in the eyes, and talk slowly without using technical jargon. Pregnant pauses are OK, and don t dominate the conversation. Show your sincerity! Sometimes, empathy can be best conveyed with deeds, not words. Examples include holding someone s hand while they are crying, giving a hug, customer services elements described previously, or just listening and listening and listening some more. What if the family continues to push after the initial empathy, even demanding an admission of fault/apology? This is a tough one, especially for nurses caring for patients or residents who remain in your care after the event. Nurses are literally forced to interact with angry family members on a daily basis and the pressure can be unrelenting: We need to know what happened.you know, the last nurse said the doctor screwed up.is that true?! Maybe it was you that screwed up! Instruct your clients to listen to the anger but don t get sucked in by becoming defensive or argumentative, but do continue to empathize: I know you are very angry, Mrs. Smith. Again, I can t tell you how sorry I am this happened and we all look forward to hearing what the review has to say. In the meantime, is there anything I can do for you or your family right now? Stress with your clients there is to be no speculation, jousting, or saying something because they think it s what the family wants to hear. Despite their anger and hostility, patients and families ultimately want 20 Medical Liability and Health Care Law March 2013

25 the truth and a doctor or nurse is not in a position to give them the truth until the review is complete. Doctors and nurses are, however, able to provide empathy! Document the Empathy! Every hospital or practice is different when it comes to documentation procedures, but, in general, empathy needs to be documented or the empathy didn t happen! I was giving a talk in Memphis, TN and a nurse legal consultant shared with me and her fellow audience members that doctors and nurses often claim to disclose, communicate with the patient/family, etc. postevent, but often she can t find evidence of disclosure in the chart or any of the records. So, she said, in her eyes disclosure didn t happen! At Sorry Works, we like to say that at the minimum disclosure builds a lot of great evidence for a strong defense.but disclosure must be documented to create that evidence! Again, if it s not written down, disclosure didn t happen! Call After Empathy! Doctors and nurses need to know the importance of calling risk, legal, and/or administration post-empathy. They need help to keep the ball moving forward with patients and families, and need help doing so. IV. Empathy After Little, Everyday Moments Tell your clients that empathy is not just for the big events, but also the little, every day events as well. Examples include the doctor is running late, the food is cold, the TV has been broken for two days, and a thousand other frustrations felt by patients and families on a daily basis. In training our caregivers how to empathize, it s important to give them opportunities to practice these skills so, as one senior risk manager told me, empathy becomes a reflex. What better way to practice empathy than saying sorry for all the little things that go wrong each and every day in a hospital or doctor s office? And this is more than just practice it s important to the relationships your clients have with their patients and families, and are these relationships strong enough to be saved post-event with empathy and possibly apology? If patients and families never hear sorry and their frustrations and resentment with your doctors build over time, well, when the big event hits the patient/family may only be interested in talking with a personal injury lawyer. Practice saying sorry every day! V. Run a Credible Review You and your clients need to know that the long-term credibility of any disclosure program rests with its credibility. It has to be a credible and believable process. And nowhere is this more important than the review process, especially if your client is going to report back to the patient or family that an adverse event was not caused by medical error. In such instances, the cases should have been reviewed by outside experts the caliber of experts any personal injury lawyer would use to evaluate the case. Don t let your clients grade their own papers! And we know that the patient or family may never believe your client when they say the event was not caused by error, but if personal injury is in tow and she is seeing a believable review process then the case is going nowhere. In addition to outside experts, the credibility of the review can be further enhanced by interviewing the patient or family. Get their perspective and thoughts on what happened, or didn t happen. Sometimes patients and families have lots of useful information to share you and your client just need to ask! At the minimum, interviewing a patient or family is an incredibly empathetic act which can defuse many complaints. What a Defense Lawyer Needs to Know About the Disclosure and... Wojcieszak 21

26 VI. Compensation for Errors At the time I was writing this article, I was bouncing back and forth between this piece and on-line debate with some claims analysts. The claims guys (they were all males) couldn t believe that an apology could mean anything to a patient or family, and certainly couldn t do anything after a major injury or death due to medical errors. Thanks for the apology now what is your address so my lawyer can serve you with a lawsuit? flippantly wrote one claims guy. Clueless! As you work through disclosure with your clients, simply try to think of disclosure as an accelerated claims process. You empathize, you do a credible review, and if the review shows a mistake happened, your client needs to apologize. However, a real apology not only means saying sorry, but also meeting the financial and emotional needs of the patient and family. Now, with disclosure, cases can usually be settled for less dollars and in a quicker time frame (meaning lower transactions costs), but your client has to make a fair offer. Again, coming back to the credibility issue for disclosure programs, the offers have to be fair and reasonable or word will get around that your client is taking advantage of vulnerable people with phony apologies and puny offers. Incredibly, some hospitals even think saying sorry absolves them of all financial responsibilities, and then say they were burned by the apology when they got sued! Not good. If a mistake is proven with damages, you have to help your client honestly assess the needs of the patient or family. Everything should be considered. Moreover, good disclosure programs often encourage patients and families to be represented by counsel (more below) so the process is thorough, fair, and there is no buyer s remorse. However, remind your clients that when disclosure mitigates and removes the anger, you have a golden opportunity to discuss the emotional needs of the patient and family, and sometimes the emotional needs trump financial concerns. Examples of emotional needs? Showing the family how the process has been fixed so the mistake is not repeated, which is a big want or desire for many consumers. Involving the patient or family in your patient safety efforts An apology letter Looking for different ways to memorialize the patient. Addressing emotional needs can not only be beneficial to patients and families, but also doctors and nurses that yearn for closure following medical errors. Caregivers often suffer deep emotional harm after being involved in a medical error they are often referred to as the second victim of medical error. Crafting solutions that address emotional needs (as well as financial needs) can provide healing and closure for your client s staff as well as the patient and family. VII. Hitting the Reset Button with the Plaintiffs Bar Sharks in suits. Ambulance chasers. Bottom feeders. And the list goes on and on. No more name calling! 22 Medical Liability and Health Care Law March 2013

27 Time to hit the re-set button with the plaintiff s bar. Time to lower the temperature and reduce the animosity. Disclosure offers the way. The practice in most disclosure programs is to communicate this new approach with the plaintiff s bar. Literally do outreach with plaintiff s attorneys. Take them to lunch, grab a drink, go to a ball game, or whatever. Tell them cases involving legitimate medical errors will be handled quickly and fairly, and patients and families are always allowed to be represented by counsel. Moreover, welcome their inquiries and always offer an open door. If they ever have a question about case, encourage them to call or . However, also communicate that adverse events with no errors will not receive compensation and defended all the way to jury verdict if necessary. In Massachusetts, for example, a state-wide effort for disclosure after medical errors has seen the medical society, hospital association, and bar association join forces. No kidding! It can happen elsewhere too. Disclosure offers a unique chance to align defense and plaintiff s attorneys to best serve the interests of patients, families, and doctors and nurses. Take advantage of this opportunity. Instruct your clients that outreach to the plaintiff s bar is an essential part of the development of their disclosure program and make sure it happens! VIII. Educating Patients and Families All stakeholders need to be educated about disclosure and apology, including patients and families. Over the last few years there has been an enormous amount of media coverage dedicated to hospitals and doctors saying sorry after medical errors and this has started the education process. But more needs to be done. Over the last few years I have had more and more interactions with patients and families who suffered adverse events, and I am amazed how many of these people (including well-educated people) have no idea what to do after something goes wrong, let alone what disclosure and apology can mean for them. Many patients and families often say they want to hear sorry after something goes wrong, but few know how to navigate the system to receive acknowledgment let alone any compensation due to them. In fact, sometimes patients and families run away just like doctors and nurses do post-event. There are some educational efforts getting under way. Massachusetts, for example, has launched the Massachusetts Alliance for Communication and Resolution following Medical Injury, or MACRMI. The website is MACRMI provides information and resources to patients and families who have suffered adverse medical events, and what disclosure and apology can mean for them. There is a lot of information for patients and family on how the process works and what they can expect. At Sorry Works! we also recently launched a campaign to educate patients and families about life after a potential medical error, including an e-book, downloadable flyer, and several YouTube videos. More educational work needs to be done. Patients and families need to be educated just as much as any other stakeholders in the medical malpractice issue. IX. Your Practice, Your Firm At the beginning of this article I shared the story of how my Father was shocked that I was writing a book about disclosure and apology with two medical defense attorneys. Dad couldn t believe that defense law- What a Defense Lawyer Needs to Know About the Disclosure and... Wojcieszak 23

28 yers would be in favor of an idea that should curtail their income. Dad isn t the only skeptic I ve encountered in my travels. Many of the naysayers have been an actual defense lawyers but some of the biggest supporters of disclosure are defense lawyers! Look, disclosure is the new reality. It s coming, and in some places it s already here. At Sorry Works! we tell hospitals and insurers every day to reward those defense lawyers who are supportive of disclosure, and fire those who are not. It s that simple. Yes, there are defense lawyers who are not comfortable with disclosure because a) they feel they like are losing control of their clients and the situation (pull back those reins!), and b) they feel like they will lose revenue. I tell hospitals and insurers to try to educate these lawyers and bring them around, or cut them loose. Supportive defense lawyers tell us helping their clients embrace disclosure dramatically expands and improves relationships with their healthcare clients. It puts client relationships in a whole new light no longer are we telling doctors to shut up post-event, but, instead we re encouraging doctors to do the right thing after something goes wrong and showing them how to do it (empathy followed by apology if a review has proven a mistake). We re encouraging more collaboration and communication immediately after something goes wrong, instead of the lawyer getting a call when a request for records comes in (or worse we re getting sued). Disclosure is all about being pro-active, and enlightened defense attorneys have figured out the disclosure process offers many new and different ways to have billable encounters with their clients that don t involve litigation. Looks, there will always be money to be made litigating disclosure simply offers a new way to generate revenue that your clients will feel better about. 24 Medical Liability and Health Care Law March 2013

29 Litigating the Never Event Case Angela M. Agustin Fox Hall, Render, Killian, Heath & Lyman, P.C. One American Square, Suite 2000 Box Indianapolis, IN (317)

30 Angela M. Agustin Fox is an associate attorney at Hall, Render, Killian, Heath and Lyman, P.C. in Indianapolis, Indiana. Her practice includes defense of medical, nursing, and long-term care providers and professionals in civil litigation, and works closely with health care providers, primarily long-term care facilities, on matters involving litigation, risk management, insurance captives, disputes and regulatory and licensure issues. Ms. Fox is licensed to practice law in Indiana and Kansas. She has tried long-term care and medical malpractice cases in Indiana, in addition to her prior experience of trying several misdemeanor and felony criminal trials to juries and judges in Indiana. Ms. Fox is a 2005 graduate of the University of Kansas School of Law.

31 Litigating the Never Event Case Table of Contents I. Introduction...29 II. Background...29 III. Provider Preventable Conditions...33 IV. Applicability of Never Events in a Nursing Home Context...34 V. Never Events in Litigation...35 A. The standard of care issue...35 B. Admissibility of CMS rules regarding never events, HACs, and HCACs, NQF s serious reportable events, or any reporting or studies of medical errors...36 C. Keys to successful defense of never event cases...37 VI. Conclusion...38 Litigating the Never Event Case Fox 27

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33 Litigating the Never Event Case I. Introduction The initial goal of The Centers for Medicare and Medicaid Services (CMS) never event policy was not denial of reimbursement. Instead, its goal was to improve patient safety and quality of care by providing a financial incentive to hospitals to become more conscious of their quality of care and improve patient care. However, the policy has now become a way for CMS to save money by penalizing hospitals for conditions acquired after admission, which CMS believes should not have occurred. Further, in the litigation context, Plaintiffs attorneys are attempting to use these billing and reimbursement rules as a way to mislead the jury and effectively expand the applicable standard of care. This presentation will examine the background of never events, the expansion of never events due to the passage of the Patient Protection and Affordable Care Act, never events in the long term care setting, and strategies for litigating a never event case. II. Background Since the publication of the Institute of Medicine s (IOM) 1999 report To Err is Human: Building a Safer Health System, the issue of medical errors in hospitals has been at the forefront of patient safety discussions. In its initial report, the IOM stated that hospital-acquired conditions caused by medical errors were a leading cause of morbidity and mortality in the United States. The IOM estimated that preventable medical errors were responsible for the deaths of up to 98,000 patients in the United States each year. The costs associated with medical errors due to additional healthcare costs, lost productivity, and disability were estimated between $17 and $29 billion. The IOM s report prompted a flurry of responses and reporting initiatives. Five states Massachusetts, California, New Jersey, Arizona, and Maine introduced bills regarding medical error reporting laws for hospitals. The Joint Commission, which accredits and certifies more than 19,000 health care organizations and programs in the United States, also developed and instituted reporting requirements for its hospitals, as well as developing a Sentinel Event Policy. The federal government also responded to the perceived need for additional reporting of medical errors by providers by enacting the Patient Safety Quality Improvement Act of 2005 (PSQIA). However, PSQIA s reporting of medical errors was totally voluntary. Finally, the most significant response was the 2002 response from the National Quality Forum (NQF), entitled Serious Reportable Events in Healthcare, identifying 27 adverse events that are serious, largely preventable, and of concern to both the public and the healthcare providers. NQF published the list to encourage state reporting efforts of serious reportable events. This list has been periodically updated, most recently in 2011, and now lists 29 serious reportable events--or never events --in healthcare, in various settings: hospital, outpatient or office-based surgery centers, skilled nursing facilities, and office-based practices. However, the reporting initiatives proved inadequate to reduce or eliminate medical errors. The next step was an effort to create a link between reimbursement and quality of care. In 2001, the IOM followed up its initial report with a second report entitled Crossing the Quality Chasm, which recognized the need to align reimbursement and payment of hospitals with quality improvement initiatives. In response to various reporting initiatives and studies, Congress authorized CMS to adjust Medicare payments to hospitals to encourage the prevention of hospital-acquired conditions. On February 8, 2006, President George W. Bush signed the Deficit Reduction Act of 2005, Section 501(c) of Pub. L , which amended Medicare hospital payment provisions at section 1886(d)(4)(D) of the Social Security Act and required the Secretary of Health and Human Services to select at least two HACs that are (1) high cost, high Litigating the Never Event Case Fox 29

34 volume, or both; (2) identified through ICD-9-CM coding as a complicating condition or major complicating condition that, when present as a secondary diagnosis at discharge, results in payments at a higher Medicare Severity-Diagnosis Related Group (MS-DRG); and (3) reasonably preventable through application of evidence-based guidelines. In sum, the Department of Health and Human Services was to create its own list of never events which, if occurred, could result in a decrease of Medicare payments. Beginning October 1, 2007, CMS required hospitals to begin reporting on claims for discharges, and specifically note whether the selected conditions were present on admission. If the conditions were acquired in the hospital, the higher Medicare payment would be denied. Under the final version of the law, the Secretary of Health and Human Services published a list of hospital-acquired conditions for which Medicare payment would no longer be made as of October 1, The initially identified HACs were: pressure ulcers; certain types of falls and trauma; surgical site infection-mediastinitis (infection in the chest) after coronary artery bypass graft surgery; foreign object unintentionally retained after surgery; vascular catheter associated infection; catheter associated urinary tract infection; administration of incompatible blood; and air embolism. After several expansions and clarifications of the original list of HACs took place, the decision was made that an updated list of HACs would be proposed every fiscal year. The list of HACs for fiscal year 2013 is as follows: HAC Foreign Object Retained After Surgery Air Embolism Blood Incompatibility CC/MCC (ICD-9-CM Codes) (CC) (CC) (MCC) (CC) (CC) (CC) (CC) (CC) Pressure Ulcer Stages III & IV (MCC) (MCC) 30 Medical Liability and Health Care Law March 2013

35 Falls and Trauma: - Fracture - Dislocation - Intracranial Injury - Crushing Injury - Burn - Other Injuries Catheter-Associated Urinary Tract Infection (UTI) Codes within these ranges on the CC/MCC list: (CC) Also excludes the following from acting as a CC/MCC: (CC) (CC) (MCC) (MCC) (CC) (CC) (CC) (CC) (CC) Vascular Catheter-Associated Infection (CC) (CC) (CC) (CC) Litigating the Never Event Case Fox 31

36 FY 2013 Final HAC List HAC CC/MCC (ICD-9-CM Codes) Manifestations of Poor Glycemic Control (MCC) (MCC) (CC) (MCC) (MCC) Surgical Site Infection, Mediastinitis, Following (MCC) Coronary Artery Bypass Graft (CABG) Surgical Site Infection Following Certain Orthopedic Procedures Surgical Site Infection Following Bariatric Surgery for Obesity And one of the following procedure codes: (CC) (CC) And one of the following procedure codes: , 81.23, 81.24, , 81.83, Principal Diagnosis (CC) (CC) Surgical Site Infection Following Cardiac Implantable Electronic Device (CIED) (CC) And one of the following procedure codes: 44.38, 44.39, or (CC) (CC) And one of the following procedure codes: 00.50,00.51,00.52,00.53,00.54, 37.80,37.81,37.82, 37.83,37.85, 37.86, 37.87, 37.94, 37.96,37.98, 37.74, 37.75, 37.76, 37.77, 37.79, Medical Liability and Health Care Law March 2013

37 Deep Vein Thrombosis and Pulmonary Embolism Following Certain Orthopedic Procedures (MCC) (MCC) (MCC) (CC) And one of the following procedure codes: , , or Iatrogenic Pneumothorax with Venous Catheterization FY 2013 Final HAC List HAC (CC) CC/MCC (ICD-9-CM Codes) And the following procedure code III. Provider Preventable Conditions Section 2702 of the Patient Protection and Affordable Care Act of 2010 requires the Secretary of Health and Human Services to issue Medicaid regulations (effective July 1, 2011) which prohibit federal payments to states under section 1903 of the Social Security Act for any amounts expended for providing medical assistance for health care-acquired conditions (HCACs). Specifically, the Statute directs the Secretary of Health and Human Services to: (1) identify the current state practices that prohibit payment for HCAC and incorporate those practices, as appropriate, into Medicaid policy regulations; (2) ensure that the Medicaid HCAC regulations do not impact beneficiary access to care; (3) define the term health care-acquired condition in accordance with Medicare s inpatient hospital statutory language at 1886(d)(4)(D)(iv); and (4) apply Medicare s provisions regarding the identifiable hospital acquired condition (HAC) and never events to Medicaid regulations, excluding any condition identified for non-payment under Medicare that may not be applicable to Medicaid. On June 30, 2011, CMS published a final rule implementing the requirements of Section The final rule requires that states implement non-payment policies for provider preventable conditions (PPCs), including HCACs and other provider-preventable conditions (OPPCs). The minimum set of conditions that states must identify for non-payment are: Category 1 Health Care-Acquired Conditions (for any inpatient hospital settings in Medicaid) Foreign Object Retained After Surgery Air Embolism Blood Incompatibility Stage III and IV Pressure Ulcers Falls and Trauma, including fracture, dislocations, intracranial injuries, crushing injuries, burns, electric shock catheter-associated urinary tract infection Litigating the Never Event Case Fox 33

38 vascular cather-associated infection manifestations of poor glycemic control (diabetic ketoacidosis, nonketotic hyperosmolar coma, hypoglycemic coma, secondary diabetes with ketoacidosis, secondary diabetes with hyperosmolarity) surgical site infection following corognary artery bypass graft-mediastinitis, bariatric surgery, orthopedic procedures deep vein thrombosis/pulmonary embolism following total knee replacement or hip replacement with pediatric and obstetric exceptions Category 2 Other Provider Preventable Conditions (for any health care setting) wrong surgical or other invasive procedure performed on a patient surgical or other invasive procedure performed on the wrong body part surgical or other invasive procedure performed on the wrong patient OPPCs identified in the state s plan and according to the requirements of the final regulation The expansion of Medicare s never events into Medicaid certainly continues the trend of patient safety and the reluctance to expend government funds on treatment that is reasonably preventable through proper care. This expansion through the Patient Protection and Affordable Care Act impacts more potential plaintiffs since Americans on Medicaid topped 50 million in June 2010; 48 million were served by Medicare in IV. Applicability of Never Events in a Nursing Home Context While Medicare s never events are largely focused on hospitals hence the term hospital acquired conditions nothing precludes Medicare or Medicaid from denying payments to skilled nursing facilities based on a never event. However, instead of denying payment on the front end, CMS will typically request reimbursement after an investigation. Often, this investigation will involve the State s Medicaid Fraud Control Unit, which is the criminal law enforcement unit of the Attorney General s Office. The MFCU is tasked with investigating and prosecuting Medicaid providers who commit fraud and/or resident abuse, neglect and exploitation in long-term care facilities. These allegations of fraud and/or resident abuse, neglect, and exploitation often involve one of NQF s serious reportable events, or may involve a HAC or HCAC under CMS. If allegations are substantiated, MFCU often pursues civil monetary repayment of all or a portion of any Medicaid program funds under the theory that the Medicaid provider did not provide adequate services to recipients. Another way that CMS monitors never events or serious reportable events in the long term care setting is through the survey process. Medicare and Medicaid-certified skilled nursing facilities are required to undergo annual surveys in order to determine if the facilities are complying with Federal Requirements. The survey process was initially developed to improve quality of care; however, similar to the serious adverse events or never events, a reimbursement or penalty scheme also grew out of the desire to improve resident safety and care. If a facility receives a tag involving quality of care, then the facility may be assessed a monetary penalty based on the severity of the tag. The monetary penalty, can also be retroactive to the date of the alleged noncompliance and may stay in effect until the facility is found to be in compliance with the federal regulations. In addition, facilities may be penalized by being prevented from admitting Medicaid or Medicare patients for a period of time. Fines and denial of admissions are analogous to CMS treatment of never events in the hospital setting in that the regulatory agency is attempting to tie quality of care issues to reimbursement to allegedly ensure patient safety and a certain quality standard for healthcare. 34 Medical Liability and Health Care Law March 2013

39 V. Never Events in Litigation Not only do CMS never events, including Medicare s HACs and Medicaid s HCACs effect reimbursement to hospitals, but they also provide additional challenges to the hospitals defending patient care issues in the civil arena. Never events are serious, dangerous matters, and can complicate litigation. A 2008 Hospital Professional Liability and Physician Liability Benchmark Analysis released by risk management services provider Aon Corp. and the American Society for Healthcare Risk Management noted that four categories of HACs--hospital-acquired infections, hospital-acquired injuries, unintentional retention of foreign objects during surgery, and pressure ulcers--comprise 12.2 percent of total annual medical professional liability costs. The aforementioned study also noted that claims associated with these four categories of conditions account for one out of every six claims filed in the United States. While Plaintiffs counsel may present these never events as evidence of below the standard of care, it is important to remember that never events are billing and reimbursement rules, and do not define the standard of care. A. The standard of care issue Never events do not and cannot define the standard of care provided to patients or residents. The concern that such a claim would be made was evident from the initial introduction of the never events policy. Initial discussion among providers and insurers highlighted the concern that the use of the term never events and the heightened public awareness surrounding the highlighted HACs would create a strict liability standard for hospitals. Plaintiffs attorneys often argue that the HACs create a new standard of care, as defined by CMS. This would, therefore, hold hospitals strictly liable if the patient could show that he or she suffered a never event. The hospital would automatically be held responsible for the harm, even if the care provided met the applicable standard of care. However, this was not the intent of the implementation of HACs, HCACs, or never events. CMS cannot augment the standard of care to hold providers absolutely liable if a never event or HAC occurs. If such an allegation is made, defense counsel must immediately challenge this allegation. CMS never events are simply reimbursement rules that have no impact on the standard of care for healthcare providers. CMS pronouncement of never events simply defines certain types of care for which CMS will or will not reimburse providers. Defense counsel should educate opposing counsel and the court that the standard of care is defined by the standard of practice of others in the profession, or what a reasonable provider would do in the same or similar circumstances. By implementing never events, CMS has not created a new standard of care. Plaintiffs attorneys may also argue that the occurrence of a never event is negligence per se. Negligence per se is the doctrine whereby an act is considered negligence because it violates a certain statute or regulation, usually a public safety statute. The exact definition of negligence per se varies by state. In Indiana, an unexcused or unjustified violation of a duty dictated by statute is considered negligence per se. Before determining that the violation of a statute constitutes negligence, however, the court must scrutinize the statute and consider the purpose of the enactment, the persons whom it was intended to protect and the injuries that it was intended to prevent. Plaintiffs may argue that when a never event occurs, the provider has violated its duty as dictated by CMS federal rules. However, defense counsel needs to note that the purpose for the federal rules regarding never events is not to create a standard of care but to address billing and reimbursement. The pronouncement of never events was never intended to extend the applicable standard of care for providers, but to set reimbursement guidelines to improve quality of care. The law in Indiana would suggest that the CMS rules do not fall within a negligence per se analysis. Another popular argument among Plaintiffs attorneys, especially in cases involving unintentional retention of an object during surgery, is that the occurrence of a never event or HAC is res ipsa loquitur, or the thing speaks for itself. In most jurisdictions, medical malpractice cases involve expert testimony regard- Litigating the Never Event Case Fox 35

40 ing the applicable standard of care and whether the breach of that standard caused the damages complained of by the Plaintiff. Medical negligence is not generally a conclusion that may be reached by a jury without such an expert opinion among the evidence presented. However, the rules of res ipsa loquitur may satisfy this requirement, especially in cases involving sponges or other instruments left inside a patient after surgery. The fact that unintentional retention of an object after surgery occurred is enough to satisfy the breach component of negligence in Indiana. Res ipsa loquitur eliminates the need for plaintiffs to produce an expert witness to testify regarding breach and causation, because the act is so obviously negligent that a layperson can recognize it. However, never events are rarely, if ever, analyzed under res ipsa loquitur. Again, CMS cannot and did not augment any legal doctrines or standards of care. Defense counsel must be prepared to educate the court and the jury that HACs and never events are medically complex and may be caused by a variety of factors which are not proximately related to any alleged negligence. If res ipsa loquitur is a valid argument in your jurisdiction, then the provider s conduct, causation, and damages become especially important to defeat the allegation of negligence. B. Admissibility of CMS rules regarding never events, HACs, and HCACs, NQF s serious reportable events, or any reporting or studies of medical errors Again, defense counsel should argue first and foremost that any discussion regarding never events, hospital acquired conditions, health care acquired conditions, or serious reportable events are terms associated with billing and reimbursement rules, and are not relevant to defining the applicable standard of care. These rules, studies, and terminology do not seek to define the standard of care for a particular community, nor do they define a national standard of care. Further, they do not assist the trier of fact in making a determination as to duty, breach, causation, or damages. The term never event and arguably, serious reportable event is certainly prejudicial to the defendant healthcare provider, and should be deemed inadmissible pursuant to the Federal Rule of Evidence 403 balancing test. The term never event was coined in 2001 by Ken Kizer, MD, former CEO of the National Quality Forum, in reference to medical errors that should never occur. It is not a term grounded in medicine or the law, and was thrust upon CMS in an effort to tie reimbursement and billing to medical errors. More importantly, CMS does not use the term never event ; CMS refers to unreimbursable events as HACs, or hospital acquired conditions. Under the PPACA, Medicaid refers to these events as HCACs, or health care acquired conditions. The term does not exist in federal statute, rules or regulations, and should not be used in court due to its propensity to mislead the jury. Plaintiffs attorneys must enter evidence of a plaintiff s damages at trial, specifically medical specials or bills. Defense counsel must be on guard for an attempt to also introduce evidence that CMS refused to reimburse the provider for the plaintiff s treatment because CMS decided that the treatment was for a HAC. Counsel will undoubtedly argue that CMS decision to not reimburse for the treatment was because the care was substandard or negligent and resulted in a HAC. Several objections must be made to the aforementioned conduct. First, although the bills may be relevant from a damages perspective, reimbursement from CMS is not relevant to a determination of liability. In many jurisdictions where the collateral source rule applies, it is also irrelevant and inadmissible to allow information regarding how a collateral source such as CMS handled payment of a patient s medical bills. However, in some jurisdictions, including Indiana, evidence of discounted medical bills is admissible in order for a jury to determine the reasonable cost of medical expenses. If there is a dispute regarding the reasonable cost, then the opposing party is permitted to introduce contradictory evidence, including discounted medical bills. The adjustments or accepted charges for medical services will assist 36 Medical Liability and Health Care Law March 2013

41 the finder of fact in establishing reasonableness (i.e. the discounted bills are reasonable since that was what CMS paid). Although evidence of discounted medical bills is helpful to the Defendant from a damages perspective, it may be harmful if the Plaintiff wants to rebut the discounted medical bills with evidence that CMS did not reimburse the provider because of a hospital acquired condition. It is likely that a discourse involving CMS reimbursement policies would still be inadmissible in states that allow discounted medical bills because these jurisdictions still do not allow a discussion regarding the identity of the payor source. Because CMS cannot be revealed as the payor, Plaintiffs attorneys would not be allowed to present evidence surrounding the reasons behind certain reimbursement decisions. C. Keys to successful defense of never event cases Successful defense of never event cases begins with a thorough review of the Plaintiff s complaint. If the Plaintiff alleges negligence per se based on CMS never events or HACs, or Medicaid s HCACs, defense counsel should move to dismiss the whole Complaint or, at a minimum, move to strike any allegations based on CMS reimbursement rules. Next, careful attention must be paid to Plaintiff s discovery requests. Defense counsel should be wary of any requests by Plaintiff to conduct discovery about Plaintiff s billing, especially regarding CMS decisions regarding reimbursement. Proper objections should be made to these inquiries, noting that such requests are irrelevant and not reasonably calculated to lead to the discovery of admissible evidence. Defense counsel should also draft appropriate interrogatories to Plaintiff, requesting the exact nature and extent of all damages or injuries to any alleged incidents, names and address of health care providers seen before, during, or after the date of the alleged incident, and to specify any treatment or care that should have been given that was not given to the Plaintiff. Emphasis should be placed on the complexity of any medical issue, and that a person s medical history may have also played a role in the ultimate outcome. Discovery of the patient s true underlying medical condition may assist in a better resolution for your client. Careful examination of the standard of care and a solid explanation as to causation are also key to the successful defense of never event cases. Upon admission to a hospital or skilled nursing facility, several assessments are performed. It is important to look at the risk factors of the individual patient at admission. Risk factors for falls, pressure sores, and infection are just some examples of admission assessment done by providers. For example, careful attention must be paid to a person s history of pressure sores, especially recent pressure sores. Also, a thorough risk assessment must be done to evaluate the patient or resident s risk for developing pressure sores. Some risk factors for pressure sores include mobility/immobility, incontinence, nutrition, psychotropic drug use, friction, age, and restraints. Turning and repositioning schedules must be implemented by the provider to help minimize the risk of development of pressure sores. Fall risk assessment may also be performed regarding the patient. Hospitals and skilled nursing facilities often assess patients for risk of falls to institute preventive measures. Careful examination of the patient s chart will alert defense counsel to the patient s risk of certain conditions. Counsel will be able to argue that even though these conditions were hospital-acquired, the patient presented with high risk for the occurrence of these conditions, and that even with good care, could not have been prevented. A skilled expert can examine the care given while at the hospital, and opine that the standard of care was met. This is particularly helpful regarding stage III and IV pressure sores. Physicians with expertise in wound care can opine and educate the jury regarding pressure ulcer identification, initial assessment, education and development of the treatment plan, nutritional assessment and support, management of tissue loads, ulcer care, assessment of ulcer healing, monitoring, and reassessment of treatment plan and evaluation of adherence. Litigating the Never Event Case Fox 37

42 In cases involving surgical retention, if Plaintiff proves the elements of res ipsa loquitur, then the burden shifts to the Defendant to disprove at least one of the elements. For example, hospitals can argue that a non-employee physician had control over a particular instrument, and not the hospital. Res ipsa loquitur would not apply to the hospital. Often, the burden shifts to the defendant to explain how the provider met the standard of care, which will also be dependent on strong expert testimony. In some jurisdictions, including Indiana, evidence that the physician relied on nurses to count sponges, and testimony that this complied with the standard of care is admissible and can be considered in the overall determination of whether a defendant provider fell below the applicable standard of care. See Chi Yun Ho, M.D. v. Frye, 880 N.E.2d 1192, 1201 (Ind.2008). Careful explanation plus an examination of the care given to the patient while at the hospital or skilled nursing facility will aide in defending these cases successfully. VI. Conclusion The term never event is simply a term meant to stir up images of substandard care. It is a term that is not used by the NQF, Medicare, or Medicaid. It was originally a term used to increase awareness of medical errors and increase patient safety and quality of care but has evolved into a buzz word for Plaintiffs. Meant to inflame juries, the term is highly prejudicial and unhelpful to the trier of fact. Knowing the true etiology of the term allows defense attorneys to successfully defeat claims involving never events, and allows both parties to focus on the patient and the care that was given. 38 Medical Liability and Health Care Law March 2013

43 MMSEA and Its Practical Considerations Examined in The Light of Day Vanetia K. Wetherspoon Western Litigation 9821 Katy Freeway Ste 600 Houston, TX (713)

44 Vanetia K. Wetherspoon is a senior vice president with Western Litigation Inc. in Houston, and a veteran health care industry claims professional. Her recent work has focused on health care claims management and compliance. Ms. Wetherspoon is a DR I member and a member of the State Bar of Texas.

45 MMSEA and Its Practical Considerations Examined in The Light of Day Table of Contents I. Introduction and Recap of MMSEA s Evolution...43 II. Practical Application Issues for the MMSEA...44 III. Changes on the Horizon...47 IV. Does Enforcement Now Become a Reality? MMSEA and Its Practical Considerations Examined in The Light of Day Wetherspoon 41

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47 MMSEA and Its Practical Considerations Examined in The Light of Day I. Introduction and Recap of MMSEA s Evolution It is well known that the Medicare program is one that has been the subject of rancorous debate and intense political wrangling and disagreement. However, there is one fact which remains undisputed that of the cost of Medicare. After Social Security, Medicare is the second-most expensive public social policy program in the United States... [It] is highly popular and primarily serves the nation s seniors [and] the disabled. Daniel Beland, The Politics of Policy Change, Welfare, Medicare, and Social Reform in the United States 74 (2012). The fact remains uncontested that the burgeoning cost of Medicare is a large part of the United States government s expenditures, and growing. It is no secret that with advances in technology, people are living longer, and well past previous life expectancy ranges of 67 and 74 respectively, for males and females, as in the 1960s, when the Medicare program was adopted. As a result, insurers, employers, hospitals, doctors, other health professionals and [federal and state] governments, all have a vested interest in how well the health system operates and at what cost. Id at 75. It is against this backdrop that the Medicare Secondary Payer Act (hereafter MSP Act ) was initially enacted. If anyone has done work in the medical liability area in the last few years, one has almost undoubtedly at least heard of the MSP Act. The act is not new, in the sense that it was first enacted in 1980, with the goal of cutting costs to Medicare. It provided the mechanism by which federal liens like Medicare liens, had to be considered, and given priority, during settlement resolution. The act required that Medicare coverage applies only when no other form of insurance existed for a given medical treatment. Medicare s payments became secondary to payments made by group health plans, property and casualty insurance, or self-insureds. Medicare retained the option of paying for treatment under certain circumstances to ensure that a Medicare beneficiary received the treatment, subject to its rights of reimbursement. Additionally, the MSP provided for penalties and interest, subrogation rights and... double damages, if the government was forced to file suit to recover payment. The MSP Act went through a series of modifications with amendments and changes to the original legislation under the Omnibus Budget Reconciliation Acts in the 1980s and 1990s, but the last, most recent changes occurred in 2007, with the sweeping enactment of the Medicare, Medicaid and SCHIP Extension Act of 2007 (hereafter, MMSEA ). The MMSEA was enacted with the primary purpose of strengthening Medicare s basic right of recovery, and to ensure that Medicare serves as a secondary payer, wherever possible. From the inception, lawmakers serious intent about ensuring the utility and force of the MMSEA, has been evident. The bill was introduced in the Senate on December 18, That same day, it was read twice, considered, read a third time, and passed without amendment by unanimous consent. The following day it passed [the] House of Representatives... Later that day, {Congress broke for its winter recess}. On December 19, 2007 it was cleared for the White House, presented to [the President] on December 27, 2007, and signed into law two days later. Thus only 11 days elapsed between the bill s introduction in the Senate and its signing into law. Jennifer C. Jordan, The Complete Guide to Medicare Secondary Compliance, 1.01[6] 2011 ed. with 2012 supplement. It has been said that the insurance industry was blind-sided by the MMSEA legislation. (Id at 1-11), How was it that such a monumental piece of legislation [could] pass so quickly and quietly that it [failed to] attract the attention of the insurance industry? (Id at 1-11). The chronology of the MMSEA s speedy passage, underscores the government s intense desire to enact measures that will add to Medicare s financial coffers. As MMSEA and Its Practical Considerations Examined in The Light of Day Wetherspoon 43

48 a result, it is more than reasonably safe to say that MMSEA will not be repealed in the near future, and is here to stay. For better or worse, MMSEA is now n full effect, with the incremental threshold schedule of applicable reporting as follows. Beginning January 1, 2012, RREs were to begin reporting total payment obligations to claimant (hereafter, TPOCs ) settlements, judgments, awards or other payments over $100,000. The threshold incrementally diminished throughout calendar year 2012, and continues as follows: Amount TPOC Date On or After Reporting Required $100,000 Oct. 1, 2011 January 1, 2012 $50,000 April 1, 2012 July 2, 2012 $25,000 July 1, 2012 October 1, 2012 $5,000 October 1, 2012 January 1, 2013 $2,000 October 1, 2013 January 1, 2014 $300 October 1, 2014 October 1, 2015 It is clear that had Congress had more input from healthcare providers and industry leaders, insurance carriers, TPAs, attorneys from both sides of the bar, and even the beneficiaries themselves, we likely would have found ourselves in less of a malaise. But with a relatively brief and uncontroversial legislative history in tow, regarding its passage, the MMSEA has provided a myriad of problems for the health care industry. Providers, insurers, beneficiaries, and their attorneys alike, are all now attempting to navigate the murky waters of negotiating a liability settlement with a Medicare beneficiary. The following section highlights a few of the many challenges confronting those who are attempting to adhere to the latest MMSEA regulations, which are now in full force and effect. It shares as best as possible, practical, but not necessarily guaranteed, solutions to compliance. II. Practical Application Issues for the MMSEA There are a number of pitfalls posed by non-compliance with the MMSEA, and it is important to emphasize the two areas of concern which almost always involve these pitfalls: 1) MMSEA Reporting and 2) Conditional Payment Recovery. A third area of practical concerns and consideration will be addressed regarding Medicare Set-Aside Arrangements (hereafter MSAs ). However, currently MSAs are currently not required by Medicare s promulgating agency, Centers for Medicare and Medicaid Services (hereafter CMS ). For anyone who has worked with liability claims or lawsuits in the last three years, it would be safe to say that confusion has abounded regarding what CMS requires for compliance with the enacted MMSEA legislation. With respect to reporting to CMS, the obligation is really twofold A Responsible Reporting Entity (hereafter RRE ), i.e., provider, or insurer. or third party administrator or entity, must first make inquiry or query, to determine if the involved plaintiff or claimant is a Medicare beneficiary. Then, if the individual is a Medicare beneficiary, any payment made to them in the liability context must be reported. The Achilles heel of this reporting, however, is that it is technologically complex, takes significant resources to implement and integrate into an entity s existing systems, and can still be fraught with error, human and otherwise. For example, what if the query of the RRE failed to properly identify a plaintiff or claimant s Medicare status, (i.e., returning as a no match ) because the social security number is transmitted improperly? Or what if, despite zealous attempts to do so, the RRE has made numerous attempts to obtain the claimant or plaintiff s social security number and the individual has flatly refused to provide it? The language of the statute has stated that CMS shall impose a penalty for failure to report to CMS. (see 42 U.S.C 1395y(b)(2)B)(ii) & (iii)). Unfortu- 44 Medical Liability and Health Care Law March 2013

49 nately, the MMSEA has not provided any leeway for entities and companies (i.e., RREs) that make good faith efforts to report, but experience problems during the process, and instead poses a [mandatory] $1,000 a day per claim penalty for late reporting. David Farber, Changes from the Medicare Secondary Payer Enhancement Act (MSSEA H.R in the 111 th Congress) (see Seemingly, the simplest of issues can affect proper reporting of beneficiary liability claims to CMS, thereby creating, potentially tremendous exposure for RREs. Issues as simple as the date of incident have caused great debate between the insurance industry and CMS. (Jennifer C. Jordan, Medicare Secondary Payer Enforcement: Shifting the Burden to the Private Sector, The Brief pg. 15 Volume 39, Number 1 Fall 2009). The issue, though at first blush may appear insignificant. The liability insurance industry, particularly the medical liability industry, is typically concerned with the last date of possible exposure or injury, in addition to a isolating a proper date of injury for proper application of the relevant statute of limitations. Conversely, Medicare generally considers the date of loss to be the date of first exposure to be the date of incident or injury. (See CMS ALERT: Liability Insurance (Including Self-Insurance), No-Fault Insurance, and Workers Compensation DOI for Cumulative Injury, (October 14, 2010), RREs in the medical liability area, know that it is not uncommon to have a patient who is bringing a medical malpractice claim months or years after treatment has terminated, and the complaint fails to allege a specific date of incident, and then the RRE or insurer is left to determine an appropriate date of incident. Or, the scenario may involve a claimant alleging several separate and distinct acts of related malpractice over the course of several months or even years, such as in a failure to diagnose case. What then, is the appropriate date of loss? The RRE or insurer may guess, and provide [a] date, but so doing could subject the insurer to a claim that it knowingly provided the government false information or, at least, that it failed to comply with the MMSEA. Id at 15. For obvious reasons, many plaintiffs who are Medicare beneficiaries, and their attorneys, are unwilling to cooperate in the settlement resolution phase of a claim, thwarting the reporting process. For example, they may argue Medicare reporting is not required, and that CMS is not entitled to any proceeds from their settlement, because the case is plead alleging a wrongful death and survivorship action, or loss of consortium, and as such they argue CMS has no right to reimbursement. CMS has offered guidance in this area, and if the case involves a wrongful death claim, CMS position is that reporting is required. However, a defendant may still be left with the potential for a court challenge, depending on the jurisdiction, since that state s laws may directly conflict with position of CMS. (See Bradley v. Sebelius, 621 F.3d (11 th Cir. 2010} cert denied, 132 S.Ct (U.S. March 19,2012) (No ). Another area which has evoked tremendous consternation in the healthcare liability community, has been that of conditional payments made by CMS, and how to accurately and expeditiously determine what the government is owed. Settlements have become increasingly cumbersome to consummate, involving additional man hours and time of insurance professionals, lawyers, and RREs alike (i.e. healthcare providers). As a result, they are more expensive, due to the fact that the involved parties are routinely uninformed about what CMS monetary recovery should be, and exactly what the process is for even assuring CMS receives its monies. CMS has attempted to offer more expeditious methods such as offering conditional payment information on its recently created website portal, and even over the telephone. (See However, often times RREs are still left in the dark regarding whether it has accurate, real time access to the Final Demand figure that CMS is owed. Healthcare provider RRes, their agents, defense and even plaintiff attorneys, have all likely experienced the frustration of nearing a point in the claim or litigation where it appears resolution may be pos- MMSEA and Its Practical Considerations Examined in The Light of Day Wetherspoon 45

50 sible, and they are then forced to confront the excruciatingly slow process of awaiting a Final Demand from CMS. Oftentimes impatient plaintiffs are unwilling to wait until the matter of CMS recovery is resolved. They threaten to enlist judicial sanctions pursuant to varying state jurisdictional laws, such as mandated time periods to provide payment upon settlement of a case, as well threaten bad faith actions against insurance carriers (see Steven Wilson v. State Farm Mutual Automobile Insurance Company, 2011 U.S. Dist. LEXIS (W.D. Ky., June 15, 2011), or to even rescind their agreement to settle, altogether. Healthcare provider RREs, their agents, insurance carries, and attorneys have had to become creative, looking for innovative ways to make certain that settlements do not implode at the ninth hour, while making sure to attempt every effort at protecting Medicare s interests. When tested, differing methods have been used by RREs, with sporadic success in the courts. Such methods have been: placing Medicare s name on the check as payee (see James E. Tomlinson and Darlene Tomlinson v. William Landers, U.S. Dist LEXIS (D. Ct. Fla., April 24, 2009), where the Florida District Court rejected the carrier s argument that it was required by federal law to include Medicare on the check, and Pamela Wall v. Michael O. Leavitt, 2008 U.S. Dist. LEXIS, E.Dist.Ca.., October 29, 2008 where the Kentucky District Court held that there existed a de facto government policy of encouraging primary payers to name Medicare payee on third-party checks... and The Complete Guide to Medicare Secondary Payer Compliance Id at CS-38); placing estimated Medicare settlement funds in escrow with the court, pending Medicare reimbursement (see Richard Haskell v. Trinience Graham and Sandra M. Zambrano, 2010 U.S. Dist. LEXIS N.D. Eastern Div. IL, June 10, 2010), where the court held that the defendant risked paying double, once to the plaintiff and then to Medicare, and thus it was reasonable to warrant the court holding the funds in escrow until the parties determined whether Medicare liens existed); and complete refusal to settle, until the beneficiary evidences a willingness to satisfy or provides proof of satisfaction of Medicare s lien for conditional payments. Yet another issue which has plagued self insured providers in the health care liability setting, along with their insurance carriers, and attorneys, has been, How do we limit our exposure when settling or resolving a claim, and make allowances for future care of Medicare beneficiaries? The unequivocal answer currently, is that a RRE or defendant can attempt to limit its exposure for future medicals by establishing a Medicare set-aside (hereafter, MSA ), but it is not required to do so. However, the caveat is, if you choose to establish such a set-aside, it must protect Medicare adequately, and only Medicare, is the final determiner of whether the MSA has been established appropriately. If anyone has recently negotiated and settled a claim with a Medicare beneficiary who requires future medicals in the last year, you are likely aware of the lack of guidance offered by CMS to players in the liability area on the subject of MSAs for future care. When CMS issued [its] initial memo in July 2001, indicating that the Medicare Secondary Payer law was being enforced, and that MSAs would... be recommended in certain instances of case settlement, the circular mentioned only workers compensation claims. There was neither language, processes, nor procedures, that applied to liability claims. The Complete Guide to Medicare Id at 7-4. As a result, RREs have essentially been left to their own devices on this issue. As of this publication, CMS has not issued any definitive regulations on this subject. But, of significance, is the fact that it did issue an Advanced Notice of Proposed Rulemaking this past June 15, (see Dept. of Health and Human Services Center for Medicare and Medicaid Services, Medicare Program: Medicare Secondary Payer and Future Medicals CMS-6047-ANPRM; Federal Register Volume 77, Number 116 pp ). CMS in its solicitation of comments, makes it clear that it was soliciting comments from affected parties regarding the subject of liability MSAs due to the large volume of requests it received, requesting either general guidance, or that it review liability MSAs. CMS proposed rule regarding the use of liability MSAs was stated as follows: If an individual or Medicare beneficiary obtains a settlement and has received, reasonably 46 Medical Liability and Health Care Law March 2013

51 anticipates receiving, or should have reasonably anticipated receiving, Medicare covered and otherwise reimbursable items and services after the date of settlement, he or she is required to satisfy Medicare s interest with respect to future medicals related to his or her settlement using any one of the following options outlined later in this ANPRM. (Id at 35917). Unlike when the MMSEA passed with lightening rod speed, in publishing this ANPRM, CMS appears to understand that it is in uncharted territory and needs input from RRE industry insiders, insurance company claim professionals, attorneys and the like, in order to craft a liability MSA framework which is meaningful and attainable, if one is to be established at all. CMS was strikingly specific in laying out the choices that it was contemplating for handling liability MSAs, and it offered seven separate... options [that] would be available to Medicare beneficiaries, as well as to individuals who were not yet beneficiaries. (Id. at 35918). Though requests from the insurance defense community helped spawn CMS apparent request for rulemaking input on liability MSAs, there are those in the community who are vehemently oppose implementation of any such rule. Opposition parties cite several reasons why establishment of such a requirement by CMS regarding liability MSAs, would be detrimental to the effective resolution of healthcare liability claims. For example, they reason, CMS should go further and specifically identify the party responsible for ensuring that Medicare is reimbursed (i.e., the beneficiary himself), thus taking the burden off the settling defendant in a liability context, who is typically settling with the proviso in mind, that its liability is extinguished once a settlement or judgment is paid; otherwise, there is arguably no incentive to defendants to settle, thereby frustrating the ultimate goal of the litigation process, which is settlement. There is no settled answer regarding the use of liability MSAs at this time. The best possible approach is to review each and every healthcare claim on a case-by-case basis. In most instances, the choice will be clear. But in cases where the choice is less apparent, obvious factors to consider are: severity of injury (as it would likely require future medical intervention well past any settlement date), dollar amount of settlement (the greater the dollar value, the more likely it is that the beneficiary will need extensive medical care in the future), and delayed release from the primary doctor or healthcare provider(s) (which indicates that the beneficiary will be continuing to seek medical treatment for some time after settlement occurs. There is currently no hard and fast rule of application offered by CMS, and none apparently on the horizon regarding any of the aforementioned practical issues that confront those of us in medical liability trenches every day. RREs can only be cautioned to be methodical in their approach toward addressing these issues and others, making certain to carefully document their consideration of the issue, and how it has sought to protect Medicare s interest. III. Changes on the Horizon The previous section illustrates the extent to which implementation of the MMSEA reporting has been less than problem free for those in the defense sector of the medical liability arena. However, at the time of this paper s drafting, Congress has recently enacted, and President Obama has recently signed into law, The Strengthening Medicare and Repaying Taxpayers (SMART) Act, (see, The Smart Act, S.1718/H.R.1845 January 10, 2013). The SMART Act is a new law that has slowly been angling its way through the legislative maize in Congress, but has now made its way to final legislation. It squarely addresses some of the major impediments to medical liability claim resolution. For example, the law provides easier access to conditional payment information, allowing parties on both sides to acquire the lien information necessary to negotiate reasonable settlements that take into consideration, Medicare s interests before the settlement. The statute provides that the MMSEA and Its Practical Considerations Examined in The Light of Day Wetherspoon 47

52 claimant may, at any time starting 120 days prior to a settlement, judgment, award or other payment, notify CMS that a payment is reasonably expected and the date of the expected payment. Additionally, there are now more specific requirements on CMS to respond to a request for a final demand. CMS now has a protected period of time, or window in which it is given to respond to a request regarding how much is owed to the agency. This puts tangible limits on how long CMS can keep parties in limbo, awaiting a response regarding what was previously known widely as the conditional payment amount, or the final reimbursement amount. The statute currently gives CMS nine months in which to enact and start to carry out this provision. The new law also allows Medicare beneficiaries and other parties (with the beneficiary s consent), to gain access to a website that will allow them to download a statement of reimbursement related to the case. If this statement of reimbursement amount [is obtained from the CMS] website during the protected period... [(i.e., the 65 day window that CMS has to respond)], and the related settlement, judgment, award or other payment, is during such period, then the last statement of reimbursement amount [(i.e., final conditional payment)] that is downloaded [from the website] within 3 days before the date of settlement, judgment or award, [constitutes] the final conditional amount, subject to recovery [by CMS]... (See The SMART Act, S.1718/ H.R id at 9). If the beneficiary disagrees with the statement of reimbursement amount, he or she must provide documentation, explaining the reason for the discrepancy. Likewise the beneficiary must offer a proposal to resolve the discrepancy. The next area of significant change comes in that of the use of Medicare beneficiaries social security numbers and HICN or Medicare numbers. The Secretary of Health and Human Services for CMS will be required to modify current MMSEA reporting requirements to permit, but not require, access to Medicare beneficiaries social security or HICN numbers. This modification to the MMSEA is not required to take effect for 18 months. This provision is of huge consequence to RREs, and their agents, who have had to put in place intricate and costly systems to electronically transmit social security numbers to CMS data sources, in order to determine if a plaintiff is a Medicare beneficiary. It should also effectively eliminate much of the objection that plaintiff beneficiaries have had in the past, to providing their social security numbers due to privacy concerns, oftentimes creating roadblocks to settlement early in the claim process. In the age of identity theft, people are very protective of Social Security numbers and therefore absent a legal requirement to disclose the information, they may not do so freely. (See Medicare Payer Enforcement: Shifting the Burden, Id at 13.) Additionally, many insurers and in-house RRE departments have had to implement IT alternatives, adding data element fields to capture this information. However, a modified reporting system established by CMS will eliminate the need for reporting with these data elements. There are at least three other areas of significant change in the SMART Act, for parties involved in the activities of MMSEA reporting and repayment of CMS reimbursement amounts. They involve the applicability of various thresholds, which allow for exemption of reimbursement claims under a certain amount, the relaxation of mandatory fines and penalties, and the statute of limitations for MMSEA actions. Formerly, the language in the MMSEA was restrictive to the extent that it was seeking to collect, and poised to collect in the future, amounts which would be worth significantly less than they would ever receive. There is a point... at which Medicare [would] pay more in costs than it will ever collect. David Farber, Changes from the Medicare Secondary Payer Enhancement Act (MSSEA H.R in the 111 th Congress) (see However, beginning in 2014, CMS, through its chief actuary, will actually compare what it costs to obtain reimbursement of a conditional payment amount, versus the actual amount obtained. The actuary will calculate the cost of collection for reimbursements from liability, workers compensation and no-fault claims. The next step would be for him /her to estimate the average settlement that yields the gov- 48 Medical Liability and Health Care Law March 2013

53 ernment a cost of recovery on a MMSA reimbursement claim, and that amount would become the threshold amount. By engaging in such a practice, [CMS] will not spend more than it could collect on any claim, and thousands of small dollar claims will be able to settle more efficiently, helping beneficiaries and [the] industry. Id. Since its enactment, one of the last areas in MMSEA reporting that has struck fear in the hearts of RRE health providers, attorneys, carriers, agents, and TPAs, has been that of the potential fines and penalties that can be amassed for non-compliance. Unfortunately, the MSP statute [has not provided] any leeway for companies that make good faith efforts to report, but experience problems during the process, and instead impose a $1,000 per day per claim penalty for the late reporting. Id. The SMART ACT corrects this inequity, by moving from a mandatory penalty structure, and instead employing a discretionary imposition of fines and penalties allowed to be levied by CMS, and directs the Secretary of the Department of Health and Human Services (DHHS) to provide safe harbors for RREs, and provide them with the protection that demonstrated good faith compliance affords. The Secretary of the DHHS is also directed by statute to solicit proposals, and then issue regulations, which will, in effect specify, the types of practices and activities, which are considered in violation of the MMSEA statute. The last change that the SMART Act ushers in is a modification to the current statute of limitations provided by the MSP statute. Courts nationwide have addressed this issue with varying results (see, U.S. v. Stricker, No. CV (N.D. Ala. Aug. 12, 2011), appeal docketed, No (11 th Cir. Oct.13, 2011). The SMART Act will provide beneficiaries and stakeholders with certainty and finality by establishing a statute of limitations for all [MMSEA] claims. (Changes from the Medicare Secondary Payer Enhancement Act, Id.) In Sec.205, the last section of the SMART Act, the statute provides that an action may not be brought more than 3 years after the date of receipt of notice of settlement, judgment, award or payment that is relevant to the reimbursement amount owed to CMS. IV. Does Enforcement Now Become a Reality? This paper has attempted to bring the reader along the evolutionary path of MMSEA, illustrating that while the government initiated efforts to have RREs engage in meaningful reporting of settlements, judgments and awards through the MMSEA, it was not necessarily aware of some of the practical challenges that parties would face, along with CMS itself, in navigating this new process. The MMSEA statute was zealous in its efforts to collect amounts owed to it due to primary payer s responsibilities, and it likely still intends to be so. The emergence of the SMART ACT legislation, now simply assures that there will be a reasonableness factor intrinsically be built into the MMSEA reporting process, especially as relates to evidence of good faith compliance. This however, does not mean that CMS has abandoned its efforts to obtain significant recovery monies in the Medicare Secondary Payer context. Essentially, despite the favorable strides that will be made with the SMART Act, the government gives no indication that it is either ready or willing, to do an about face on the issue of primary payer reimbursement. As a result, the question that has been whispered in the halls of RREs, healthcare providers, attorneys, TPAs and others has been, how does the government now actually enforce its legislation, especially in light of the changes that will come with the SMART Act? The answer is that it will do what it has previously been authorized to do by statute. If it files suit for non-reimbursement, the government can recover double damages (Id at Stricker). Likewise, it is authorized to collect interest from the date it makes a demand for reimbursement, if the debt is not resolved within 60 days. If full repayment is not received within 120 days, the Medicare Secondary Payer Recovery Contractor (hereafter, MSPRC ) issues an Intent to Refer Letter. MMSEA and Its Practical Considerations Examined in The Light of Day Wetherspoon 49

54 Once all associated correspondence is reviewed and resolved, the MSPRC may refer unresolved debt to the Department of Treasury under the Debt Collection Improvement Act (31 CFR 285). RRE healthcare providers, beneficiaries, attorneys, TPA, and anyone working in the medical liability context should be on the lookout for the various dates of implementation of the SMART Act, provisions. There is no question that the SMART Act will bring a more level playing field to the world of primary payer reimbursement. It will ensure a measure of practicality and predictability that heretofore has not existed in the MSP arena. The Act even includes a provision that it will solicit a comment period from the public prior to any rulemaking, asking for recommendations on practices that would necessarily warrant sanctions. So it is clear that the SMART Act requires CMS to engage in fair and reasonable enforcement practices. However, RREs and other players in the medical liability area should still be on alert to make certain that they are taking reasonable steps to comply with every aspect of the MMSEA. By way of recommendation, healthcare provider RREs, attorneys, and anyone involved in MMSEA compliance, should consider options and practices, which allow them to make internal assessment of their MMSEA practices. Depending on their available resources, affected parties should consider employing practices such as self-audits, as recommended by CMS. It should be noted that on October 18, 2012, Daniel Levinson, Inspector General of the Department of Health and Human Services, released a work plan that revealed Group Health Plans (GHPs) will be audited for non-compliance under MMSEA. Although the work plan did not reference Non-Group Health Plans (NGHPs), some speculate they will be next in line for audit. Mr. Levinson s office was quoted as saying, there is nothing indicated in the audit to audit casualty companies. But certainly, because there is an overlap, we might be working on audits in the casualty industry in the future. (see PMSI, Medical Insights.com MMSEA Section 11 Audits October 18, 2012). With the passage of the SMART Act, CMS will be made to engage in practices which are more reasonable, and which encourage time and cost efficiency. Similarly, parties involved in the MMSEA Reporting process will be made to look at their practices carefully as well. We would all do well to examine compliance practices in the light of day, to be sure that our reporting and MMSEA practices pass CMS muster, and that we are staying engaged on a compliance course which allows for accurate identification of payments that require reporting and reimbursement to the government. 50 Medical Liability and Health Care Law March 2013

55 A New Day and a New Way: New Techniques in Preparing Providers for Deposition Michael A. Gross Michael A. Gross Law, LLC 1911 Serpentine Circle South Saint Petersburg, FL (505) [email protected]

56 Michael A. Gross has been a litigator for 34 years in high profile cases and was co-counsel in a $54 million dollar verdict, the highest civil verdict in the history of New Mexico. He is rated AV by Martindale Hubbard and named a Southwest Super Lawyer from Mr. Gross is now devoted exclusively to a national practice of preparing defense clients for what he believes is the most important day in the litigation the day of their deposition. He acts as co-counsel in a limited representation role to provide independent cross-examination and rehabilitation services to defendants and law firms nationwide.

57 A New Day and a New Way: New Techniques in Preparing Providers for Deposition Table of Contents I. The Deposition...55 II. The Cross-Examination...55 III. The Solution...56 IV. Underlying Emotional Issues...57 V. Who Needs Intensive Deposition Preparation?...58 VI. Conclusion...58 A New Day and a New Way: New Techniques in Preparing Providers for... Gross 53

58

59 A New Day and a New Way: New Techniques in Preparing Providers for Deposition Since the Federal Rules of Civil Procedure were originally adopted in 1938, little has changed in the way attorneys prepare their clients for a deposition. Typically there are one or two meetings in advance and the attorney provides guidance and instruction on how to testify. Many providers do poorly in the deposition and it is an accepted notion that physicians do not make good witnesses. This presentation challenges the way attorneys currently prepare providers for deposition and suggests that a real cross-examination should always be conducted in advance. This will make sure the attorney knows how the provider will really respond and to allow the provider to understand and adapt to actual deposition environment. During the cross-examination the attorney should listen carefully to the responses and challenge improper ones and guide (but not instruct) accurate and truthful complete answers. It is also an opportunity to observe and change the behavioral and emotional issues that are present with most providers. Success depends on the ability of an attorney to listen carefully and counsel change that results in strong truthful testimony by the provider. I. The Deposition A critical event in a medical malpractice case is the day the healthcare provider is deposed. This is the only time that the Plaintiff s lawyer will be able to evaluate the provider and assess the provider as a Defendant in the case. Nothing is more important than a good deposition performance. A good deposition can result in a dismissal or a lower valuation of the case, but a bad one can make the provider the lead target in the case and significantly increase the exposure. Good deposition preparation can make the difference between a good outcome or failure. Consider whether the traditional way of preparing the Defendant provider really works. There is no empirical evidence that the traditional lecture to clients and requiring the client to remember the numerous rules provided actually works. The client will be facing an actual cross-examination from a real Plaintiff s lawyer and the question is Can your client think and provide good answers to an actual cross-examination? If the client has not learned how to do this, can he or she do well when facing a real cross-examination? II. The Cross-Examination When you conduct a real cross-examination of your client, you will discover exactly how the provider will respond at the actual deposition. If you pay attention and listen to the responses you will readily see the problems with the way the provider listens and responds to questions. If you do not conduct a realistic crossexamination and recreate what the client will really face, there is no way to assess how your client will do at the deposition. Your client will also not be able to prepare for what a real cross-examination feels like if the preparation is not made to feel like the real deposition. Cross-examination also reveals certain testifying traits and helps to identify problems. Here are just a few problems you can identify with clients while a cross-examination is being conducted: The client does not listen to the question. A New Day and a New Way: New Techniques in Preparing Providers for... Gross 55

60 The client does not carefully think about the answer. The client says the first thing that comes to mind. The client freezes up. The client makes stuff up. The client lies. The client is evasive. The client is angry. The client is arrogant. The client is easily led by Plaintiff s attorney. The client gives answers that are not responsive. The typical defense lawyer response is to then lecture the client on how to give a better answer. The client then needs to memorize or remember what to say. After a few minutes the client no longer hears what is said and at the real deposition reverts to the intrinsic responses initially given. III. The Solution Address each response directly and force the client to resolve the problem. Stay focused and require that the client solves the problem. Do not solve it for the client. For example: The client did not listen to your question carefully. Response.doctor, what was my question? When the doctor cannot repeat it or does not repeat it exactly as it was asked..your response is.doctor, do you think you can do well at your deposition if you do not listen carefully to the question? How important is it for you to listen if you want to win this case? What will happen if you do not carefully listen to each question that is posed? The client is evasive in the answer. Response..doctor, why were you trying to evade giving a truthful, candid answer? Do you think that being evasive will be helpful to your case? Do you think that being anything other than completely honest will be good for you? Do you think a jury will like a physician who appears to be evasive? The client is arrogant or displays disdain for the question. Response.doctor, did I say something that made you angry? Do you think you were being cooperative in your response or were you antagonistic? Do you think that being arrogant will be good for your case? Am I the first person to suggest that you display arrogance? The client is easily led. Response.doctor, do you think that giving the answer the Plaintiff wants you to give will be good for your case? If not, what do you think you can do to give your own original answer and not the one you are being led to? Every response to an issue you identify needs to be framed in a format that allows your client to work internally to arrive at their own solution to the problem. That is what ultimately makes them a good witness at their deposition. 56 Medical Liability and Health Care Law March 2013

61 Cross-examination will definitely reveal the problems with the testimony and it is the perfect opportunity to let the client find a way to articulate answers and understand the facts better. IV. Underlying Emotional Issues Every client brings to the deposition underlying emotional issues which drives their testimony. You can discover these emotional drivers and help defuse them so the client gives pure testimony free of unwanted emotional overlays. Cross-examination may reveal these underlying issues: Anger Guilt Fear Avoidance Insecurity Responsibility Victimization Difficulty with confrontation or aggressiveness It is important to handle these issues when they appear as a failure to do so will result in a repeat at the actual deposition. How do you handle emotional issues? Can you try to confront them and help the physician recognize how the emotion impairs giving clear testimony? You may try to ask these types of questions: Anger Doctor, you appear to be angry that you have been sued. What is it that makes you angry? Do you think the legal system always results in adverse verdicts? What percentage of cases do you think are settled? Are you afraid of losing money and your assets? Do physicians ever pay out of their own pocket money to settle cases or pay judgments? Do you think that you are the only physician to be sued? Do you have colleagues who have been sued? Did it affect their reputation and stature in the medical community? Can you let go of your anger so you can win this case? Evasion Doctor, you seem to evade giving clear answers to my questions. Do you think you should be evasive? Do you think jurors will like you if you are evasive? Why do you feel the need to be evasive? Where did you learn that a Defendant should not give clear complete answers in depositions? Guilt Doctor, do you feel guilty because your patient died? Did you do every-thing that was reasonable? Is your view of the events in hindsight making you feel guilty about the result? Can you feel empathy for the family instead of guilt? Is guilt a result of an intentional decision to do something wrong as opposed to feeling bad about the outcome? Did you choose to do something wrong? Is guilt the correct emotion to feel under these circumstances after you consider it? Can you let your feeling of guilt go away? When you feel guilt in this case are you being fair to yourself? A New Day and a New Way: New Techniques in Preparing Providers for... Gross 57

62 V. Who Needs Intensive Deposition Preparation? These are key indicators to identify clients who can benefit from intensive preparation: 1. Clients who resent being sued and express anger and frustration with the legal process. 2. Clients with prior judgments or adverse verdicts. 3. Clients who have had prior cases settled for more than nuisance value. 4. Clients who evidence arrogance or attitude issues. 5. Clients with a history of drug or alcohol abuse or participation in physician assistance programs. 6. Clients with a history of reprimands or terminations from employment. 7. Clients who are foreign trained or for whom English is a second language. 8. Clients with Medical Board License limitations or suspensions. VI. Conclusion Preparing a client for deposition gives you a unique opportunity to learn about the case but, more importantly, understand how your client will actually testify. Conducting a real cross-examination will give you the opportunity to help your client discover good responses that are truthful and clear and make your client the strongest part of your case, not the weakest. The most difficult part of the preparation process is to always ask questions that help the provider figure out a way to provide complete truthful answers and not instruct them how to do it. Instruction is not effective but creating a learning environment where the student provider figures out what to say and how to say it using their own processing abilities is highly effective. The emotions and underlying issues that providers bring to the law office are significant but all too often ignored by attorneys. Confronting those emotions and resolving them can make a provider a powerful witness. As attorneys we now have an opportunity to change the way we prepare providers to testify and insure truthful clear testimony that comes directly from the provider. Our system of civil justice will be well served by this new way to prepare for depositions. 58 Medical Liability and Health Care Law March 2013

63 Impact of Obesity in Medical Outcomes and Lawsuits Dennis C. Smith, Jr., MD, FACS, FASMBS WellStar Comprehensive Bariatric Services 55 Whitcher Street, Suite 410 Marietta, GA (770)

64 Dr. Dennis C. Smith, Jr. is the Medical Director of the Bariatric Surgery Program for the WellStar Health System at Kennestone Hospital in Marietta, Georgia. He has been doing bariatric surgery since 1997 and laparoscopic bariatric surgery since He regularly performs the Duodenal Switch, the Roux-en-Y Gastric Bypass, the Sleeve Gastrectomy, and Adjustable Gastric Bands, as well as revisions of those procedures. Dr. Smith is a long-time leader and innovator in laparoscopic bariatric surgery, serving as faculty for many courses teaching laparoscopic bariatric operations and techniques, and presenting techniques and results at national and international meetings.

65 Impact of Obesity in Medical Outcomes and Lawsuits Table of Contents I. Introduction...63 II. Epidemiology...63 III. Etiology of Obesity...63 IV. Health Implications...63 V. Other Effects of Obesity...64 VI. Weight Bias and Discrimination...64 VII. Obesity in Medicine...65 VIII. Treatment of Obesity...66 IX. Surgical Treatment of Severe Obesity...66 X. Medicolegal Aspects of Bariatric Surgery...67 XI. Avoidance of Malpractice Claims...69 XII. Patient Contracts...70 XIII. Minimizing Risk in the Performance of Bariatric Surgery...70 XIV. Complications After Surgery...71 XV. Expert Witnesses...71 XVI. Summary...71 Impact of Obesity in Medical Outcomes and Lawsuits Smith 61

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67 Impact of Obesity in Medical Outcomes and Lawsuits I. Introduction Obesity is a rapidly growing problem in the United States and around the globe. It is the fastest growing health care problem in the US. It is commonly referred to in recent years as the epidemic health issue of our time. It affects virtually all aspects of a person s life, and shortens lives significantly, as well as adding massive costs to health care for society overall. In addition, health care adds to the cost of doing business in the form of added programs, structural modifications, and legal costs related to litigation and protection from litigation. II. Epidemiology Obesity is defined as a BMI of 30 or more, where BMI is defined as kg/m 2. Obesity is now at about 30 percent of the adult population in the United States and is expected to increase steadily from there. By 2018 it is estimated that more than 40 percent of the adult population in the US will be obese or heavier, and in that year it is estimated that some $340 billion dollars will be spent on health care related to obesity. Much of those funds will be public/government funds [The Future Costs of Obesity: National and State Estimates of the Impact of Obesity on Direct Health Care Expenses. Nov, Based on research by Kenneth E. Thorpe, Ph.D., Emory University]. III. Etiology of Obesity Obesity has come to be considered a disease process rather than simply a disorder of willpower. Causes of obesity in our culture are multifactorial, and include genetics, environmental effects such as portion sizes and poor quality food. Also implicated are sedentary lifestyles, psychological factors, and medical conditions such as hypothyroidism and musculoskeletal issues. Generally the more processed and Westernized a population s diet, the more obesity is in that population. IV. Health Implications Severe obesity causes or contributes to a multitude of medical problems that significantly impair health. Obesity-related illnesses include Diabetes, Hypertension, Sleep Apnea, Hypercholesterolemia, Hypertriglyceridemia and many other disease processes that involve nearly all major organ systems. Health costs directly or indirectly attributable to obesity are increasing rapidly and driving up the overall cost of health care in developed countries the world over, and especially in the United States. These medical problems, referred to as co-morbid conditions, also contribute to the documented shortened lifespan of morbidly obese individuals who remain in a morbidly obese condition, relative to the lifespan of those who undergo bariatric surgery and are thus removed from the condition of morbid obesity. These co-morbid conditions recede for the majority of patients who are able to lose a great deal of weight, whether it is by surgical or non-surgical means. The cost of health care per capita is increasing rapidly as a result of these co-morbid medical conditions. Studies now confirm that interventions such as bariatric surgery can pay for themselves over about two years by reducing the costs of treating these co-morbid conditions. The justification for bariatric surgery is largely the reduction of these medical problems and the associated cost and health benefits rather than cosmetic improvements. Impact of Obesity in Medical Outcomes and Lawsuits Smith 63

68 V. Other Effects of Obesity Bias against the obese is widely prevalent and deeply ingrained in our society. While many other areas of prejudice have been greatly suppressed, especially in the media, disparaging portrayals and jokes aimed at obesity remain very common. Entire movies are regularly produced that center around fat jokes. In popular movies with a group of characters involved, there is often an overweight character who is considered an easy target for jokes related to weight. Bias exists in everyday life as well. Obese persons are commonly viewed by non-obese people as being lazy, lacking in willpower, drive and intelligence, being malodorous, having less worth, being gluttonous, and being noncompliant. In the legal arena, there is evidence that overweight and obese persons may be judged differently solely because of their weight [Schvey NA, Puhl RM, Levandoski KA, Brownell KD. The influence of a defendant s body weight on perceptions of guilt. International Journal of Obesity Jan;1:1-7]. As a result, the obese person often feels social rejection, has poorer relationship quality, demonstrates poorer academic performance, is more likely to avoid continuing education, and is more likely to avoid seeking healthcare. Effects on employment include inequitable hiring practices, lower wages, and poorer career advancement. Further, these tendencies end up resulting in a person with diminished self-esteem, social isolation and poor social support systems. Health care is compromised, leading to elevated health risks, increased morbidity and mortality, and a shortened lifespan. Socioeconomic status is reduced as well. Overall, the person with severe obesity has a tendency toward poor physical, mental, economic and social health. VI. Weight Bias and Discrimination In terms of social justice, there are few protections for the obese. Until the past few years, laws protecting against discrimination against the obese were very few and far between [Puhl RM, Moss-Racusin CA, Schwartz MB, Brownell KD. Weight stigmatization and bias reduction: perspectives of overweight and obese adults. Health Education Research Sep;23(2): ]. The Equal Protection Clause of the U.S. Constitution does not consider health, education, housing or employment to be fundamental rights. The Americans with Disabilities Act [Americans with Disabilities Act, 42 U.S.C ] protects well against those with actual disabilities, but this has not historically protected against common weightbased discrimination [Staman, J. (2007). Obesity discrimination and the Americans with Disabilities Act (RS22609). Washington, DC: Congressional Research Service]. The ADA defines a disability as a physical or mental impairment that substantially limits one or more major life activities. Protected status includes those with a history or record of such an impairment, or a person perceived by others as having such an impairment. Protection has been conferred upon those with a disability related to diseases and conditions resulting from excess weight, but not to those with the excess weight alone. Extending this Act to those with only excess weight as a problem has been seen as tantamount to declaring those with excess weight as being disabled, which has been considered a problematic stance. Obesity is similarly poorly protected from discrimination under the Rehabilitation Act of Section 504 of the Rehabilitation Act states that no otherwise qualified individual... shall, solely by reason of her or his disability,... be subjected to discrimination under any program or activity receiving Federal financial assistance. [29 U.S.C. 794(a)], however this has not been extended well to obesity in the courts. 64 Medical Liability and Health Care Law March 2013

69 Recently, as in a Montana Supreme Court ruling in 2012 [BNSF RY. CO. v. FEIT, 281 P.3d 225 (2012), 2012 MT 147], the ADA Amendments Act of 2008 has been more broadly interpreted to classify obesity alone as an impairment that should be protected against discrimination. However, this has yet to gain wide acceptance. Title II (Two) of the ADA calls for businesses and institutions to provide equal opportunity to benefit from all of their programs, services and activities. This has been interpreted in a more beneficial way for the obese population. Under this section of the ADA, public education, employment, health care, social services, the courts, voting venues, town meetings, etc. must be accessible to those with disabilities. This has led to the development of the ADA Standards for Accessible Design (2010) [28 CFR part 35], a code detailing requirements for architectural standards, policies, practices and procedures, and methods of communication for those with sight, hearing and speech disabilities. This has required the removal of barriers to this access in existing buildings and facilities, and also the inclusion of appropriate access in new construction. There are other regulations that have extended to the obese, via more broad interpretation. The Fair Housing Act, Sec [42 USC 3601 note] requires owners to make reasonable exceptions in their policies and operations in order to afford equal opportunities. The Air Carrier Access Act [49 USC 41705] prohibits discrimination against the physically or mentally disabled, and this extends to foreign carriers as well. There are also regulations that protect against discrimination in the areas of education and incarceration. The law is still imperfect at protecting those with excess weight against common discrimination. The Yale Rudd Center, an influential clearinghouse and advocate for those with disabilities, has made recommendations that would serve to improve protection against discrimination [Weight Bias, A Social Justice Issue A Policy Brief, 2012, RR Friedman, ScM, RM Puhl, PhD]. On the Federal, State and Local government level, they call for including weight as a protected class under civil and human rights statutes, creation of new weightbased employment discrimination legislation mirrored off of the ADEA [29 U.S.C. 621], and the alignment of state disability laws with the ADA Amendments Act to cover weight-based impairments and perceived impairments. The Rudd Report also calls for State and Local School Boards to adopt and enforce policies prohibiting harassment, intimidation, bullying and cyber-bullying on school property or by school peers, and to include weight as a specific protected category. Rudd further calls for teachers and staff to be trained on how to recognize and intercept prohibited behavior in order to effectively enforce these policies. In the health care arena, the Rudd Report recommends inclusion of language on weight bias in patients rights policies. Rudd also calls for coverage of obesity as a diagnosis that is a reimbursable expense. VII. Obesity in Medicine Apart from causing obese persons to be more reluctant to seek medical care, obesity results in overall poorer healthcare in other ways as well. For a multitude of reasons, obesity can contribute to delays in diagnosis. Complaints made by obese patients are often not given as much credence. It is often the case that complaints are assumed to be related to their obesity, and are not given the investigation or treatment they warrant. Because of the extra weight, examination of these patients is more difficult, and it is more difficult to appreciate findings when they are present. Diagnostic equipment can often not accommodate very heavy patients. Following procedures such as surgery, recognition of complications can be very difficult as well for all of the same reasons. In addition to the more tangible issues involved with care of the obese patient, there are the additional problems that can be present that include layers of psychological issues, the generally poorer likelihood of follow-up, and often poorer compliance with medications and other treatment. Impact of Obesity in Medical Outcomes and Lawsuits Smith 65

70 Severely obese patients have higher risks of infections and hernias, and limited functional pulmonary and cardiac reserves. Their mobility and conditioning are generally poor, and in addition tend toward deficient overall nutrition as a result of poor quality food intake. These aspects of health all contribute to a less effective ability to cope with stresses of illness, and thus a higher rate of hospitalizations and complications. VIII. Treatment of Obesity Treatment of obesity, especially severe obesity, is notoriously difficult. Treatment modalities include diet, exercise, psychological and behavioral modification, medical treatment, and bariatric surgery. Any one of these alone is insufficient and doomed to failure. Especially in the case of severe obesity, it is not enough to ask the patient to eat less and exercise more. Even in structured settings with close follow-up this is minimally successful, and long-term the patients almost universally gain the weight back. There are no medications in existence that project to be successful for significant or long-term weight loss. The ones that have been used have significant side effects, lead to highly variable and mostly poor results, and are at best a temporary advantage. The best chance for a person of severe obesity to lose a large amount of weight and keep it off longterm is to undergo bariatric surgery in the context of a comprehensive program, with attention to psychological and behavioral triggers, dietary counseling and long-term monitoring and follow-up. IX. Surgical Treatment of Severe Obesity Bariatric surgery means surgery for the treatment of morbid or severe obesity. Surgery is proper for certain patients once they are at a certain level of obesity, where it is impacting on their overall health in a significant way, and where it can be shown that the non-surgical methods of weight loss have been unsuccessful. This surgery is not meant for cosmetics, but rather is a well-established treatment that can substantially improve your health, and minimize some of the co-morbidities that go along with severe obesity, such as hypertension, diabetes, sleep apnea, degenerative joint disease, etc. The use of surgery for the treatment of morbid obesity has gained favor over the past 20 years, largely due to the recognition of the comprehensive program approach. There are several different types of operations, and there are rigid criteria as to who qualifies for surgery. The program refers to all of our weapons in attacking the problem: surgery, nutrition, exercise, psychologists, medical specialists, etc. The Consensus Conference of the National Institute of Health (NIH) in 1992 defined the patient selection criteria as being greater than 100 pounds over the ideal body weight for a given height, or with a Body Mass Index (BMI) greater than 40. A patient could also qualify with a BMI between 35 and 40 if a patient has one of the major co-morbidities directly related to severe obesity present, such as hypertension, diabetes, sleep apnea, or disabling arthritis, etc. Bariatric Surgery is not appropriate for every patient, and extensive screening and preparation are done with each prospective patient. In addition, a very small fraction of obese people who could qualify for surgery are actually interested in it we only currently are operating on about 1 percent of the population who could qualify. The simpler operations lose less weight, and have fewer complications, while the more complex operations lose more weight and are more prone to complications. Overall the observed weight loss varies from about 50 percent of the excess body weight with Lap Banding, to about 85 percent of the excess body weight with the Duodenal Switch. The overall mortality is about 0.1 percent [Buchwald H, Avidor Y, Braunwald E, Jensen MD, Pories W, Fahrbach K, Schoelles K. Bariatric surgery: a systematic review and metaanalysis. JAMA Oct 13;292(14): ]. 66 Medical Liability and Health Care Law March 2013

71 The four major operations done most commonly in the US for the treatment of morbid obesity are: the Biliopancreatic Diversion with Duodenal Switch, and the Roux-en-Y Gastric Bypass, the Sleeve Gastrectomy, and Adjustable Gastric Banding. All four are most commonly done laparoscopically. Each has its strengths and weaknesses, and there are situations when a surgeon might feel that one or the other is better for a particular patient. Each operation also has side effects and possible complications that are particular to that operation. The Duodenal Switch is a mixed malabsorptive and restrictive operation. It combines a Sleeve Gastrectomy with a longer small bowel bypass in order to effect restrictive as well as malabsorptive weight loss. It is associated with the best long-term weight loss, but carries a higher risk of nutritional abnormalities. The Roux-en-Y Gastric Bypass is still considered the Gold Standard operation. The operation makes a small pouch at the top of the stomach, and then routes the food through a Roux limb of small bowel, bypassing the major part of the stomach and a relatively short portion of small intestine. The RNY is the second most powerful operation for weight loss, but does involve some malabsorptive effects, though to a lesser degree than the Duodenal Switch. The Sleeve Gastrectomy is a relatively new option for bariatric surgery patients. It can either be done as a standalone procedure or as part of a staged approach to a Duodenal Switch or a RNY Gastric Bypass. The weight lost is somewhat less than the RNY, but it is associated with fewer post-operative complications and fewer nutritional concerns. Adjustable Gastric Banding utilizes a silastic device that is placed around the upper part of the stomach to restrict the size of the stomach. It has the advantage of being a less invasive operation than the other surgical alternatives, but it is generally considered to have more long-term complications related to it being a foreign body. The weight loss seen is highly unpredictable, but is generally less than the other three operations. Most bariatric surgeons feel strongly that the best results from bariatric surgery are obtained when the surgery is done in the context of a comprehensive bariatric surgery program. The program consists of: Bariatric Surgeon, Program Nurse Coordinator, specialized Nursing Staff on Floor and in OR, Internists and other medical specialists, Psychologists, Dietary and Nutrition Services, Support Groups, and also extends to having the appropriate equipment in the office and hospital to accommodate severely obese patients. The patient is extensively educated before and after surgery on how to achieve and maintain success. Follow-up is crucial both for achieving success and for avoiding nutritional and other complications. Bariatric programs follow their patients very closely during the first year, with visits every 3 months or so. Follow-up is then for the rest of the patient s life, on a yearly basis. Most programs obtain a broad spectrum of labs at three months, six months, and one year post-op, and then yearly for the rest of the patient s life, to assess nutritional status. Support groups are a very important part of a bariatric program. Bariatric surgery programs may also have Internet message board areas that help with support and education of both pre-ops and post-ops. X. Medicolegal Aspects of Bariatric Surgery Litigation is a constant concern in the performance of bariatric surgery, despite every precaution. Problems can arise with patient selection and preparation, surgeon qualification, hospital qualification, the inherent risks of the operations, and the aftercare of the operations. Bariatric surgery has been a popular target of plaintiff attorneys, and there is a subculture of expert witnesses who participate in the process. Impact of Obesity in Medical Outcomes and Lawsuits Smith 67

72 As is well known in the legal profession, there are certain conditions that must be present for malpractice to be considered to have occurred. There must be a duty to treat on the part of the treating health care provider, an occurrence of harm, a breach in the standard of care, and the concept of causality must be present. There are few studies of malpractice litigation published in the literature. The top two areas of litigation in bariatric surgery [Kaufman AS, McNelis J, Slevin M, La Marca C. Bariatric surgery claims - a medicolegal perspective. Obes Surg Dec;16(12):1555-8] are: a) Faulty patient screening and education b) Delay in recognition and treatment of complications Technical errors are a less common issue, but do occur. Inadequate MD training, hospital or office staffing, inappropriate credentialing and deficiencies of informed consent account for many other instances of litigation. Unfortunately there are few standards that are etched in stone regarding the proper administration of bariatric surgery, but there are some generally accepted standards of care. These are in a constant state of evolution as new information is gained in the field. One of the best sources for these is the AACE/TOS/ASMBS Guidelines [Mechanick JI, Kushner RF, Sugerman HJ, et al. American Association of Clinical Endocrinologists, The Obesity Society, and American Society for Metabolic & Bariatric Surgery Medical guidelines for clinical practice for the perioperative nutritional, metabolic, and nonsurgical support of the bariatric surgery patient. Surg Obes Relat Dis. 2008;4(supplement 1):1 83]. It is doubtful that there will ever be an accepted standardization of techniques in bariatric surgery. Factors that increase risk for mortality include male gender, age > 50-55, an open procedure vs. laparoscopic, congestive heart failure, peripheral vascular disease, and chronic renal failure [Nguyen NT, Masoomi H, Laugenour K, Sanaiha Y, Reavis KM, Mills SD, Stamos MJ. Predictive factors of mortality in bariatric surgery: data from the Nationwide Inpatient Sample. Surgery Aug; 150(2):347-51]. In some studies, presence of diabetes and Medicare status are also identified as risk factors. In one of the only studies evaluating actual malpractice claims published, the most common adverse events leading to litigation in bariatric surgery were leaks (53 percent), abscess (33 percent), and bowel obstruction (18 percent) [Cottam D, Lord J, Dallal RM, Wolfe B, Higa K, McCauley K, Schauer P. Medicolegal analysis of 100 malpractice claims against bariatric surgeons. Surg Obes Relat Dis Jan-Feb;3(1):60-6; discussion 66-7]. The most common outcomes associated with litigation were death (53 percent), near full recovery (28 percent), minor disability (12 percent) followed by major disability (7 percent). A published commentary from the legal field [Eagan MC. Bariatric surgery: malpractice risks and risk management guidelines. Am Surg May; 71(5):369-75] reviewed experience with bariatric malpractice claims versus non-bariatric claims, and found a higher severity of injury with bariatric claims with more death claims (40 percent vs. 23 percent of all claims). Also noted was a higher average indemnity ($183K compared to $173K for all claims) and more indemnity payments (43 percent compared to 31 percent for all claims). Obesity, especially severe obesity, increases risk of malpractice litigation in all types of medicine. As an example, Cohen details incidence of medical negligence lawsuits relating to labor and delivery [Cohen WR. Medical negligence lawsuits relating to labor and delivery. Clin Perinatol 2007 June; 34(2): , vii-viii]. Shoulder dystocia is a recognized occurrence during delivery, and obesity is clearly a risk factor for shoulder dystocia. Factors cited in litigation included use of inappropriate maneuvers to remove the impacted shoulder, failure to use appropriate maneuvers, and failure to have appropriately trained and experienced personnel at the time of delivery. 68 Medical Liability and Health Care Law March 2013

73 XI. Avoidance of Malpractice Claims Attempts to avoid litigation are always present in the mind of an appropriately cautious health practitioner. Obviously it is important to have things go well, but it s also very important to have taken the proper steps along the way, so that if things don t go well, there are fewer areas to target for the plaintiffs. Careful preoperative screening, evaluation and medical clearance of patients is an extremely important starting concept. The NIH criteria must be met, but this is not as universally followed as one might think. Some surgeons will operate outside the criteria if the patient is a self-pay and strongly desires surgery. In this situation the surgeon obviously has little defense if things don t go well. Screening of patients must include comprehensive medical evaluation as well as psychological evaluation. Patients are evaluated for possible substance abuse, compliance issues, and their level of social support. Although it is difficult to justify ethically, consideration should in some cases be given to a patient s financial resources, since the follow-up care, lab studies, vitamins and supplements that are necessary for success can be expensive for those without insurance coverage. A history of prior litigation would not render a patient a non-candidate, but it is a good thing to know when entering into a doctor-patient relationship. This is usually elicited and reported via the psychological evaluation. Proper preparation of patients and significant others for surgery also includes extensive education about the risks and benefits of surgery, and about how to keep themselves healthy and out of trouble after surgery. In our program, we use live classes, reading materials, videos, support groups, and quizzes, with a great deal of redundancy in the process. Education continues while in the hospital and post-operatively as patients move through the various stages of recovery and dietary progression, and on into the long-term follow-up. Another very important component of the preparation for surgery is the informed consent process [Wee, C. C., Pratt, J. S., Fanelli, R., Samour, P. Q., Trainor, L. S. and Paasche-Orlow, M. K. (2009), Best Practice Updates for Informed Consent and Patient Education in Weight Loss Surgery. Obesity, 17: ]. The preoperative education process is all part of the informed consent process as well. Risks are discussed in the live sessions, in the videos, and in the discussion with the surgeon at the pre-operative visit. The consent form itself is very long and detailed, and includes many places for the patient to initial or sign. The family and/or significant other are included in this process. The patient signs a contract that covers post-operative behaviors and acknowledges their responsibility in maintaining their health. The patient also signs a video completion certification to acknowledge that they have watched the videos and have understood the material. The patient s significant other also signs a letter of support. The patient must have a Primary Care Physician (PCP), and that PCP must agree to continue caring for that patient after they ve had bariatric surgery. A letter of support is obtained from the patient s PCP. This sometimes (though less often the last several years) requires the patient to change PCP s. The informed consent process should be an integral part of the overall operation, and should be utilized not only to educate the patient and family, but also to improve communication between the physician and the patient and family Steven [Raper E, Sarwer DB. Informed consent issues in the conduct of bariatric surgery Review Article. Surg Obes Relat Dis., 2008 Jan-Feb; 4(1):60-68]. Done properly, it should help to improve the doctor-patient relationship, improve outcomes, and improve patient safety. Another important factor that deserves emphasis is to impart realistic expectation onto the patient and family [Wee CC, Jones DB, Davis RB, Bourland AC, Hamel MB. Understanding patients value of weight loss and expectations for bariatric surgery. Obes Surg Apr; 16(4): ]. This really begins with the program s marketing materials and web presence, and extends throughout the evaluation and education pro- Impact of Obesity in Medical Outcomes and Lawsuits Smith 69

74 cess, and should be practiced by all those who come in contact with the patient on behalf of the program. The patient should be made to have realistic expectations not only of the risks of surgery, but also of expected weight loss, pain levels, nausea levels, what vitamins and supplements will be necessary and how much they ll cost, etc. Categorical predictions and goals should be avoided. XII. Patient Contracts One of the more common modalities in modern bariatric surgery is the concept of patient contracts. These are documents that detail many of the behaviors that are expected of the patient after surgery, including following up appropriately, taking the proper vitamins and supplements, avoiding negative behaviors like smoking and ingestion of caustic substances, etc. These are non-binding, but serve to emphasize the importance of these factors in the patient s long-term well-being, and can be used to show in another way that the patient understood these things heading into surgery. The patient can be shown to have been a true and willing partner in the decision-making process. The patient s family or significant other is also included in this process. XIII. Minimizing Risk in the Performance of Bariatric Surgery Risk management in the performance of bariatric surgery requires meticulous technique and the observance of specialized safety measures. Well-trained and attentive surgeons as well as covering surgeons are necessary. Timely and thorough documentation is always of paramount importance. A properly trained and experienced team of health care providers helps eliminate errors and avoid stress and friction for the patient as they go through the process. When problems do arise, prompt attention, evaluation and attention are critical to avoiding delays in diagnosis. Once the operative phase is over, it remains very important to maintain close follow-up, good and prompt communication, and frequent patient re-education. Bariatric operations seem to be best accomplished in centers that demonstrate a commitment to safe and appropriate bariatric patient care [Nguyen NT, Nguyen B, Nguyen VQ, Ziogas A, Hohmann S, Stamos MJ. Outcomes of bariatric surgery performed at accredited vs nonaccredited centers. J Am Coll Surg Oct; 215(4):467-74]. Standards followed should include specialty trained personnel, proper equipment for the care and evaluation bariatric patients, standardized clinical pathways, etc. Surgery volumes performed at bariatric centers have been proposed as a measure of competence. Volume does appear to improve outcomes as long as the volume attains a certain minimum level, but beyond that doesn t seem to continue to improve outcomes as volume rises [Gould JC, Kent KC, Wan Y, Rajamanickam V, Leverson G, Campos GM. Perioperative safety and volume: outcomes relationships in bariatric surgery: a study of 32,000 patients. J Am Coll Surg Dec;213(6):771-7]. It is felt that too much volume might impair the doctor/patient relationship, thereby increasing the likelihood of subsequent litigation, especially if the operating surgeon is buffered from spending time with the patient. Interestingly, as the ASMBS moves toward a joint certification process for Bariatric Surgery Centers of Excellence, volumes are no longer a hard criterion for qualification. In addition to meticulous technique, there are many factors in the OR that can make a difference in outcomes, and these must be included in any program s performance of bariatric surgery. A consistent team is extremely important. IV access can be difficult in severely obese patients, and some provision should be made to obtain safe and reliable access, whether it is by multiple large-bore IV sites, or a percutaneously placed catheter in the arm or central vein. 70 Medical Liability and Health Care Law March 2013

75 As with any complications during or after surgery, timely recognition and correction is critical, and it is best to do the proper intervention as completely and thoroughly as possible the first time, as often there is but one chance to make things right. Conversion to an open operation should not be inappropriately delayed, and help should be summoned if it proves necessary. XIV. Complications After Surgery Complications following bariatric surgery are unavoidable. Bleeds, marginal ulcers, internal hernias, etc. will occur. Keys to more successful outcomes are having a high index of suspicion for complications, taking prompt steps toward evaluation and intervention, and maintaining good communication with the patient and significant other(s) throughout the process. Delays in diagnosis can be catastrophic. XV. Expert Witnesses Having a knowledgeable and competent expert can make a critical difference in the defense of malpractice claims. Ideally, there should be a great deal of input from the expert, and on an ongoing basis throughout the process. The expert should be an active part of the defense team, and should take part in the determination of standards and breaches, review of testimony, assistance with other experts and resources for the defense, and in court testimony. The ASMBS has produced guidelines for expert witnesses, and there are some key elements of these guidelines that merit emphasis [R. M. Dallal, M.D.*, D. Cottam, N. Bertha, F. Bonanni, E S. Bour, R. E. Brolin, K. Keith, A. Petrick, W. A. Sweet, R. P. Blackstone. Qualifications of expert witnesses in bariatric surgery medicolegal matters Dec; ASMBS Patient Safety Committee, from Both sides should have at least one expert who has expertise in bariatric surgery. The expert involved should have significant direct experience with the operation about which he or she acts as an expert. The expert should show a dedication to the practice of bariatric surgery, with direct patient care experience. The expert should have > 24 hours of AMA PRA Category 1 CME every 3 years. All of these criteria should be met at the time of the alleged negligence. In the performance of his or her duties, the expert should exercise confidentiality, maintain integrity and avoid conflict of interest, and testimony should be prepared with accuracy and impartiality. The ASMBS Code of Ethics [ asserts that expert witnesses should serve as experts for plaintiffs and defendants. Views that are alternative to or differing from prevailing views should be referenced in testimony. Compensation should not be based on the content of the testimony or on the outcome of the case. Finally, testimony should be presented as that of the expert, and not that of the ASMBS. XVI. Summary Obesity is a problem of epidemic proportions in our society, affecting every aspect of the lives of those afflicted. The costs associated with obesity are staggering, and are increasing exponentially. Costs relate not only to health care, but to the accommodation for obese persons in society, and to the liability expenses that come with obesity. As the etiology of obesity is multi-factorial, so will be any solution, and will require fundamental changes in our society. Impact of Obesity in Medical Outcomes and Lawsuits Smith 71

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77 Defending High Risk and Catastrophic Neurosurgical Cases John E. Hall, Jr. Hall Booth Smith & Slover PC 191 Peachtree St NE, Suite 2900 Atlanta, GA (404)

78 John E. Hall, Jr., one of the founding partners of Hall Booth Smith & Slover PC, resides in its Albany, Georgia, office. Mr. Hall specializes in the defense of high exposure cases, including medical malpractice, construction, commercial litigation, mass torts, transportation and product liability. He has tried in excess of 100 civil cases. Mr. Hall is licensed in Georgia and Tennessee. He has been named in The Best Lawyers in America, selected as a Super Lawyer, and received the Insurance Man of the Year Award.

79 Defending High Risk and Catastrophic Neurosurgical Cases Table of Contents I. Standard of Care...89 II. Damages...89 III. Conclusions...90 Defending High Risk and Catastrophic Neurosurgical Cases Hall 87

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81 Defending High Risk and Catastrophic Neurosurgical Cases The defense of High Risk and Neurosurgical cases is a challenge and an honor. Aggressive defense of these claims requires awareness of the ever changing developments in medicine, and well as the new and varied approaches to the trial of these cases. The role of experts is key in defending these cases from both the standard of care as well as from a damage perspective. The experts used will not only be involved in new medical techniques and treatments, but will also provide expert opinions on causation and damages. I. Standard of Care A. Aggressive defense of these cases requires background in the changing medical diagnosis and treatment. B. Experts are required who are up to date, knowledgeable, and can serve the two prong purpose of educating counsel, and educating the jury. C. Standard of care is in most cases a national standard of care. D. Role of experimental treatment and clinical trial awareness can be a key component of the defense of the case. 1) Diagnosis is often an issue. Was the diagnosis correct? 2) Treatment options are always the choice of the patient and present issues of Informed Consent. 3) How much treatment? E. Where to get experts? 1) Medical literature. 2) Universities and research institutes. 3) Referrals from defense counsel. 4) Medical seminars and presentations. F. Be prepared to refute and address plaintiff s initial expert. 1) Allegations in the Complaint. 2) Affidavit, Certificates of Merit, other initial pleadings. 3) What is the basis of which plaintiff is complaining and will base their case at the start? 4) Be prepared for that to change as the case develops. II. Damages A. Causation: 1) Any other causation for the alleged damages? a) Genetics, family history, drug or ETOH abuse, sports injuries, falls. b) Nature of degenerative neurological disease process in everyone. c) Complete medical history is key. d) Prior claims for similar or related injuries including falls, head trauma, or vision issues. Defending High Risk and Catastrophic Neurosurgical Cases Hall 89

82 2) Are all of the alleged damages related to the claimed injury?. a) Preexisting, injuries? b) Role of witnesses to previous condition of plaintiff. B. Experts: 1) Traditional medical experts may not be able to address the claims of damage in the case. a) Alleged damages of the Plaintiff may not be objective. b) Films, functional testing, school records and related behavior issues. c) Experts are required to address of these allegations. d) Physiatrist, Psychologist, and Social workers may become new experts. e) Be prepared to address life care and economic damages. f) Damages will often be subjective. g) IME. 2) Experts to address each and every damage claim of plaintiff is necessary including long term financial claims. a) Role of governmental and other collateral sources. b) Levels of care and support alleged should be evaluated completely. 3) Defending these claims of damage. a) Be prepared for jury presentation with strong sympathy appeal. b) Be prepared to address issues of long term disability and life care issues. c) Be prepared to control and address issues of sympathy. III. Conclusions Aggressive defense of neurosurgical cases requires defense attorney to be aware of and prepare to defend a case from both standard of care and damages. These cases are moving targets with high-dollar damages. Defense of either of standard of care or damages alone can be a formula for disaster. New and different experts than you have used in the past will be necessary, and your knowledge of the ever-changing medicine and treatment options will be key. Early and aggressive preparation is necessary to achieve a successful conclusion of the case for your client. Damage claims will be high, and all aspects of the case must be addressed with a view towards a defense of the case that is supported medically, and is understandable to a jury. 90 Medical Liability and Health Care Law March 2013

83 The Second Chair at Trial Role, Responsibility and Reporting Annie J. Dike Helmsing, Leach, Herlong, Newman & Rouse, P.C. P O Box 2767 Mobile, AL [email protected]

84 Annie J. Dike is an associate with the Helmsing, Leach, Herlong, Newman & Rouse, P.C. law firm. Ms. Dike obtained her undergraduate degree summa cum laude from the University of Alabama in 2004 and her Juris Doctorate cum laude from the University of Alabama School of Law in Ms. Dike s main practice focus is medical malpractice defense, product liability, and creditor s rights. She is admitted to practice in the State of Alabama and the Middle, Northern, and Southern Districts of Alabama as well as the Northern District of Florida. Ms. Dike also serves on the steering committee of the DRI Medical Liability and Health Care Law Committee, the Board of Directors for the Alabama Defense Lawyers Association, and the Mobile Bar Association Young Lawyers Executive Committee. She was named as an Alabama Rising Star and one of Benchmark Litigation s Top 250 Women in Litigation in 2012.

85 The Second Chair at Trial Role, Responsibility and Reporting Table of Contents I. Note-Taker...95 II. Keeper of the File...95 III. Witness Coordinator...95 IV. Lookout...96 The Second Chair at Trial Role, Responsibility and Reporting Dike 93

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87 The Second Chair at Trial Role, Responsibility and Reporting I. Note-Taker The Second Chair s primary focus at trial is to take detailed, organized notes during each day of trial. These notes should include effective summaries of the testimony provided, but also arguments from opposing counsel during side-bars, the court s rulings and instructions, any observations of jurors, witnesses, parties, etc. The Second Chair s notes should give the client a detailed picture and account of what occurred at trial that day. The notes will also be used to prepare each day s report to the client and for future reference in preparing subsequent witnesses, trial motions, closing arguments, etc. On the first day of trial, the Second Chair should be prepared to take thorough, effective notes during voir dire. It is usually best to have a chart made of the voir dire panel. As soon as the jury list is provided, begin filling out the chart immediately, putting each juror s name, age, race, gender and occupation to the extent practicable, in the box for each juror. Then, as the First Chair conducts voir dire, the Second Chair should input information in each of the juror s boxes, noting comments they make, information they divulge and other non-verbal impressions and observations. If possible, the Second Chair should begin color-coding or otherwise rating favorable and non-favorable jurors to assist the First Chair in the jury selection process. During opening statement, the Second Chair should take detailed notes on the evidence Plaintiff s counsel claims will be presented during the course of the trial as it will be helpful to point out to the jury later if Plaintiff does not fulfill these promises. During witness examinations, the Second Chair should be mindful of the substantive testimony given but should also take note of non-verbal communications from the witness or reactions from the jury to the witness s testimony. The Second Chair s notes will serve as the client s eyes and ears in the courtroom. They need to be thorough and organized for easy reference and conversion to client reports at the end of each trial day. II. Keeper of the File The Second Chair will also serve as keeper of the file. That is, the Second Chair needs to know where every document, publication, deposition, exhibit, etc. is located and be able to access it quickly and easily for the First Chair. Time spent fumbling and searching for documents at trial translates to loss of attention and trust of the jurors. The Second Chair should also try to anticipate the need to pull depositions, literature, exhibits, etc. before the First Chair asks for it. Before a certain witness takes the stand, the Second Chair should make sure all depositions, exhibits or other materials that the First Chair may need in examining that witness are easily accessible and ready to pull at a moment s notice. If technology is used at trial, the Second Chair should also be familiar with the technology and know how to use it or how to effectively communicate with the technician that will be using it so demonstrative aids can be pulled up quickly for use during witness examinations. Typically, the technician will have a method for referring to exhibits, either by bates numbers or exhibits numbers. The Second Chair should be familiar with this method and well-versed in it so that he/she can easily communicate with the technician to ensure the proper images are blown up during the First Chair s examination of witnesses. III. Witness Coordinator The Second Chair is also typically responsible for ensuring all witnesses know when they will likely be called and have them prepared and ready to testify when they are needed. The Second Chair should ensure The Second Chair at Trial Role, Responsibility and Reporting Dike 95

88 all witnesses are available at least an hour before they are needed and that they wait in a secure area or are instructed on the need to refrain from any substantive communication with attorneys, jurors, etc. at the courthouse. The witness should be secluded if possible, but if not, be sure the witness is aware that people they talk to on the elevator or lobby may be a juror or family member or otherwise connected to the trial so they should refrain from discussing the case in any regard with anyone at the courthouse. The Second Chair should also try to meet with the witness before he or she is called to testify to refresh trial preparation and calm them before they take the stand. Testifying at trial is usually a very nervewracking experience for people who are not familiar with or comfortable in the courtroom, and a few words of comfort and a familiar face can go a long way to ease the tension of a nervous witness right before they take the stand. The Second Chair should also discuss appropriate attire with the witness to ensure they know what they should wear for trial, whether that be their work uniform or simply professional attire, such as that which the witness would wear to a business interview. The Second Chair needs to ensure the witness understands what is appropriate to wear and what is inappropriate and that they understand the importance of their appearance and demeanor in the courtroom. IV. Lookout During trial, the First Chair is often blinded by thoughts of cross-examination, evidentiary issues, witness outlines, etc. so that he/she often cannot effectively watch the goings-on in the courtroom. The Second Chair serves as his lookout. Meaning, the Second Chair needs to keep an eye on the jurors to watch for reactions, non-verbal cues and other significant observations. The Second Chair should also watch the parties, the plaintiff and family members and interactions between plaintiff s counsel and witnesses. Oftentimes, seemingly insignificant exchanges between attorneys and parties or between jurors can reveal a great deal. The Second Chair needs to be on the lookout for these things. In addition, the First Chair is often so mentally pre-occupied with minute, focused issues, he/she cannot see the forest for the trees. The Second Chair needs to be looking at the big picture to ensure the First Chair obtains asks all of the necessary questions to establish defenses and that the witnesses provided the necessary testimony. The Second Chair should be flipping through outlines as the witness is on the stand to make sure everything is checked off. The Second Chair also needs to be prepared for the First Chair to look back at the end of an examination for confirmation that they have gathered everything they need from that witness. If there are additional questions the Second Chair believes should be asked, he or she should write them down and give them to the First Chair or request a brief moment to discuss them before the witness is excused. 96 Medical Liability and Health Care Law March 2013

89 The Second Chair at Trial Role, Responsibility and Reporting Pamela S. Schremp CNA 8268 Browning Court Mentor, OH (440)

90 Pamela S. Schremp is a Director of Strategic Claim Oversight in the CNA Specialty Healthcare business segment. In this role, Ms. Schremp oversees the evaluation, monitoring, management, and resolution of major claims, investigations, exposures, and other risks. Drawing on her background as a registered nurse, advanced practice nurse, Director of Risk Management for an academic medical center, and an attorney, Ms. Schremp is very involved with CNA s Aging Services program. She collaborates with internal and external business partners to identify trends, issues and opportunities to positively impact services provided to Aging Services insureds and clients. Ms. Schremp was previously a litigation attorney with the Law Offices of Steven K. Kelley, a staff counsel office of CNA. Prior to joining CNA, Ms. Schremp was affiliated with the law firm Gallagher Sharp in Cleveland, Ohio, where she tried numerous medical liability cases to verdict. Ms. Schremp is a frequent speaker at national and regional conferences on issues of medical liability and risk management. She is active in DRI as a member of Medical Liability and Health Care Law Committee and serves as chair of its 2013 Long Term Care Seminar. Disclaimer: The purpose of this presentation is to provide information, rather than advice or opinion. It is accurate to the best of the speaker s knowledge as of the date of the presentation. Accordingly, this presentation should not be viewed as a substitute for the guidance and recommendations of a retained professional. To the extent this presentation contains any examples, please note that they are for illustrative purposes only and any similarity to actual individuals, entities, places or situations is unintentional and purely coincidental. In addition, any examples are not intended to establish any standards of care, to serve as legal advice appropriate for any particular factual situations, or to provide an acknowledgement that any given factual situation is covered under any CNA insurance policy. Please remember that only the relevant insurance policy can provide the actual terms, coverages, amounts, conditions and exclusions for an insured. All CNA products and services may not be available in all states and may be subject to change without notice. CNA is a registered trademark of CNA Financial Corporation.

91 The Second Chair at Trial Role, Responsibility and Reporting Table of Contents I. What the Insurance Carrier Needs to Know When a Case Is in Trial Endnote The Second Chair at Trial Role, Responsibility and Reporting Schremp 99

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93 The Second Chair at Trial Role, Responsibility and Reporting I. What the Insurance Carrier Needs to Know When a Case Is in Trial 1 Whenever a case is tried, there is a great deal of work to be accomplished, before and during trial. As the Second Chair, you are an important member of the trial team and an invaluable liaison to your client s insurance carrier ( carrier ). When considering your carrier liaison role as Second Chair, it may help you to think in terms of what information is needed by the carrier s representative to evaluate the claim and analyze the risk. Well in advance of trial, you should become familiar with your client s carrier s billing guidelines, and other requirements. You should determine whether the carrier s authorization for a Second Chair is required and, if so, whether such authorization has been given. Be prepared to discuss the types of activities performed by the Second Chair, and how the performance of such activities positively affect the representation of the insured, and/or the outcome of the claim. Those activities might arise out of the Second Chair s role as a client liaison, trial note taker, exhibit manager, and trial report writer. If possible, do not be a stranger to the claim or to the carrier s representative. Generally speaking, insurance carriers like to work with people with whom they are familiar because familiarity breeds comfort. You should actively participate in pretrial discussions and conference calls. Such discussions are an opportunity for you to demonstrate your knowledge of the facts and the law, applicable motions, and witness specific strategies. Before trial, ask the carrier s representative about what information he/she will need during the course of the trial, as well as his/her preferred method, and timing, of communication relating to the trial. Keep in mind that you are the representative s eyes and ears. A goal of your communications should be to leave the representative with the feeling that she or he is actually present in the courtroom. That strategy holds true whether you will be communicating through telephone calls, or a written report. If the carrier requires a written report, use the form provided by the carrier, or other suggested format. If, for some reason, you are not able to use a carrier s form, advise the representative and try to include the same information in your report. You may also wish to ask who will be reading the report and when the representative would prefer to receive the daily report in the evening after court or early the next morning. In the event that transmission of the report is delayed, contact the representative and let him/her know. On the first day of trial, your report should include information about the members of the venire, such as names, ages, occupations, pertinent life or other experiences, and any responses of note made during voir dire. Keeping in mind the saying a picture is worth a thousand words, if photos of potential jurors are available in the public domain, you might wish to include them. Once the jury is empanelled, consider rating each juror, and the panel overall, on a scale. During trial, in addition to reporting the facts, your observations and analysis are critical. In your report, include a summary of each witness s testimony, as well as any demonstrable effect the testimony had on the jury, Plaintiff, opposing counsel and the court. When analyzing the testimony, comment on the following: Where there any non verbal or emotional reaction by jurors, such as head nods, rolling eyes or tears? Did the testimony go as anticipated? Were there any surprises in the testimony? As a result of the testimony, are any changes needed or planned to the defense strategy? During your communications to, or with, the carrier s representative, try to mention any pertinent events, unexpected developments or notable reactions to the testimony of witnesses. Also, be sure to discuss any comments or concerns voiced by the client/insured, during the course of the trial. The Second Chair at Trial Role, Responsibility and Reporting Schremp 101

94 For each trial day, it is helpful if you rate the day overall and each witness on scale. As a courtesy, you might wish to include information on the next day s schedule of witnesses or events. While relaxing after closing arguments is understandable, do not stop reporting once the jury starts deliberating. Be sure to advise the carrier s representative of any concerns with the jury charge, and advise him/her of any questions the jury poses, along with the court s response to such inquiries. And of course, alert the representative when the jury comes back and advise him/her of the verdict. If an opportunity to resolve the claim arises during trial be sure the insured/client and the carrier s representative are timely notified. It is understood trial is a very busy and stressful time for you, the client/insured and the First Chair attorney. Timely and efficient communication goes a great distance in achieving a positive outcome for all. Endnote 1 Many insurance carriers have written guidelines for defense counsel. The suggestions offered herein are solely for discussion purposes. They are not designed to speak for the industry or to suggest a best practice. 102 Medical Liability and Health Care Law March 2013

95 Settling the High Stakes Case Amy Evans Western Litigation, Inc Katy Freeway, Suite 600 Houston, TX (425)

96 Amy Evans began her career in the office of the General Counsel for the University of North Texas Health Science Center then entered the insurance field as a coverage attorney with two Houston law firms. She left private practice in 1999, first going in-house at Western Indemnity Insurance Company and then to Western Litigation, Inc. where she has been since Ms. Evans practice focuses exclusively on medical professional claims and risk management services for hospitals, physician groups, insurance companies, captives, and risk retention groups.

97 Settling the High Stakes Case Table of Contents I. Introduction II. Define and Identify III. Prepare, Prepare, Prepare A. Pick up the Phone B. Remain Intellectually Honest C. Work Backward D. Know Your Damages E. Does Your Client Really Hear You? IV. Working All Sides to Your Middle A. Cultivate Relationships & Manage Expectations B. Identify and Eliminate Roadblocks C. Create Pressure/Leverage V. Negotiation Tactics A. Credibility B. Use the Mediator C. Resolving Apportionment D. Difficult Parties E. Non-Monetary Offers F. Remain Persistent & Patient VI. Conclusion Settling the High Stakes Case Evans 105

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99 Settling the High Stakes Case I. Introduction Anyone can settle a case. However, settling a high stakes case to your clients satisfaction requires strategy, communication and persistence. Traditionally, trial lawyers make poor negotiators because they would rather try a case than settle it. We ve all heard the saying that mediations are a waste of a good trial. The reality is that 95 percent of all cases end up settling, and with business becoming more and more competitive, the premier lawyers are those who can help their clients quickly identify and mitigate their risk. This paper will address how to identify the high stakes case and engage in successful strategies to defend and resolve them. II. Define and Identify A high stakes case is defined by the extent of exposure that a case presents to your client. Therefore, the key to identifying a high stakes case is to know your client, their business and their appetite for risk. There are the obvious cases that involve a significant injury, substantial damages, high profile facts, parties or attorneys, punitive concerns, criminal conduct, egregious facts, mass torts, product recalls or will be exceedingly expensive to defend. Those cases are apparent and readily identifiable to both you and your client. However, there are other cases that may appear benign to you, but which carry significant risk to your client. Some cases are internally or externally politically sensitive to your client while some have the opportunity to directly impact your clients business relationships and/or reputation. Some cases are insignificant on their face, but they may arise at a bad time for your client or for those with whom they do business. A simple, small lawsuit can hold up the sale or acquisition for your client. Some cases may involve basic facts, but they have the potential of making a precedential impact in the legal community and/or the arena in which your clients do business. Each of these could be a high stakes case for your client. The most dangerous cases are those which appear benign, but involve facts or details that could make the case catastrophic for your clients. The way to identify these subtle cases is maintain clear and consistent communication with your clients. While it is good for counsel to have theoretical ownership of the files, always remember that in reality, they are the clients files. If you communicate with your clients in an open and frequent fashion, there will be no surprises, and you will learn your clients trigger points. Do not assume that your clients will volunteer information. Ask your clients what they think about the case, ask them if there are any contractual or business issues that you should be aware of or that may impact the case or your client down the road, and ask them about their relationship with the co-defendants or any of the attorneys in the case. Maintain this type of communication throughout the case and be on alert for subtle issues that your client may not be considering. High stakes cases can evolve over time from something much less significant, so never disregard the small cases. The best way to handle a high stakes case is to prevent one from developing. Watch for the warning signs such as the plaintiff laying off of a party who you think should be a target defendant, co-defense counsel meeting or gathering without you, your client or a co-defendant acting odd, you get a strange feeling about the case, or you learn something that no one else knows yet but which will change the posture of the case. Great lawyers see changes coming and are prepared to redirect them or nip them in the bud. Settling the High Stakes Case Evans 107

100 III. Prepare, Prepare, Prepare A. Pick up the Phone The next step is to analyze the exposure. All lawyers analyze their cases and most do so with the end result in mind. Few, however, actually ask Plaintiff s counsel what they want. The high stakes case requires direct communication with Plaintiff s counsel early and often in order to resolve the case favorably for your client. Call Plaintiff s counsel as soon as you receive the file and ask what they are thinking about your client and what they want from your client. You d be surprised how many attorneys do not do this. We work in a technology based society where personal contact is a lost art. While s and pleadings may be standard, easier and more efficient for a modern defense practice, nothing can replace a phone call and personal meetings. Counsel should also contact the co-defendants attorneys as they appear in the case and maintain open communication about their positions. Plaintiffs aren t the only ones who can create exposure for your client. B. Remain Intellectually Honest Be intellectually honest in your evaluations. It sounds obvious and easy, but in reality it takes effort. We have all become jaded and defense oriented over the years which is natural. However, that does not benefit your client during the analysis stage save it for the advocacy stage. Place yourself in the shoes of every person in the case from Plaintiff, to their lawyer to each defendant and their lawyer, to the judge and the jury. Look at every issue from each perspective and evaluate the entire case, not just your clients exposure. True strength in negotiations comes from knowing everyone else s case as well as your own. Outline the strengths and, most importantly, the weaknesses. Know your own and which you can concede. Determine who the real parties at interest are and who is driving the case. Is it really the patient or is it an adult daughter or an in-law? Attempt to uncover their motivation or incentive as well as their pressure points. Identify what items are truly negotiable and think of creative ways around those that are not. What is the desired result for your client, for the plaintiff, for the co-defendants? C. Work Backward Imagine the worst case scenario (i.e. an excess judgment), then work backward from there. Ask how you got there, what made the jury find against your client and what drove up the value. What role did your skill and decisions play in the outcome? How was the client as a witness? What did your jury look like? How did you handle adverse rulings on key issues? Anticipate adverse rulings and prepare for them. How did your co-defendants perform? Can exposure be shifted elsewhere or was it shifted to your client unexpectedly? Great attorneys try each case in their heads a few dozen times before it ever gets to mediation or the courtroom. They are prepared for every conceivable outcome which gives them the advantage during negotiations of the high stakes case. D. Know Your Damages Evaluating economic damages is mostly a matter of collecting and dissecting data, and evaluating non-economic damages is easy in venues with tort reform. Counsel in non-tort reform states can benefit from experience, verdict and settlement searches and running cases by colleagues, friends and family. Punitive damages can be evaluated in the same fashion. However, there are other forms of damages that most attorneys fail to consider when preparing to negotiate a high stakes claim. Time, stress and strain on personal and corporate resources of a client are present in every case. The same is true for Plaintiffs. There is also some form of an impact on business relation- 108 Medical Liability and Health Care Law March 2013

101 ships and reputation. Your client may be willing to try the case at the point that mediation is scheduled, but there is a good chance that they do not realize the time, resources and stress that is inherent with trial. There is the potential for loss of employment, loss of business and loss of employees, not to mention unfavorable publicity whether they win or lose. OJ Simpson won his criminal trial, but his reputation was destroyed. Liens can bring negotiations to a grinding halt. Many defense attorneys rely on the Plaintiffs to identify and resolve the liens. Unfortunately, this is rarely done prior to, or even during, negotiations. All parties need to take an active role in investigating whether liens exist, identifying the lienholders and amounts, and reaching out to the lienholders to attempt to lower the amounts owed. This should be done well before numbers are exchanged. The relatively new MMSEA laws require that we get Medicare involved early and develop MSAs well before settlement talks begin. Finally, legal costs must be estimated and considered. The average medical malpractice case costs between $150,000 and $300,000 to get through trial. High stakes cases often cost in excess of $1M. These costs are damages incurred by all parties and are factors that should be addressed during negotiations. E. Does Your Client Really Hear You? There is nothing worse than showing up to mediation and learning that your client brought a fraction of the authority necessary to resolve the case or worse, they don t truly appreciate the significance of the case. Our busy schedules result in the vast majority of communication being by or letter. While formal reporting is a necessity and definitely has its place, there is no guarantee that the recipient is even reading your s and reports. Therefore, it is important to confirm early and often that your client understands the case, their risk, that they are realistic about the case value and that they are truly prepared to resolve the case. Again, nothing replaces phone calls and personal meetings. High stakes cases merit face to face meetings. Make sure that you are communicating with the decision makers on your team and if you are not, make sure that word is getting through to those folks. Confirm feedback from the client that shows that you are on the same page. IV. Working All Sides to Your Middle A. Cultivate Relationships & Manage Expectations Develop and maintain your relationships with the other attorneys and their adjusters, if possible. Plaintiffs counsel are often your best ally in high stakes cases involving many parties. Your client has the money that Plaintiffs counsel want, so use that to your advantage. Consistent communication with Plaintiffs counsel throughout litigation can help you direct their attention away from your client or, at the very least, it can help shape their thought process. Maintain relationships with the co-defendants so that you are not shooting at each other and driving the value of the case up for Plaintiffs counsel. Avoid discovery disputes if possible in the event you need help from the judge to bridge any settlement gaps. Tactfully state your client s position early, and repeat it throughout the case to gradually influence the expectations of others. Be flexible, patient, realistic and open minded. B. Identify and Eliminate Roadblocks Identify any road blocks to resolution and attempt to eliminate them. Is the patient or their family angry? If so, offer to have your client(s) meet with them ahead of time to listen or possibly apologize. This can ease or eliminate guilt and anger that can be an impediment to settlement at mediation. Lawsuits are Settling the High Stakes Case Evans 109

102 often expensive therapy sessions for many Plaintiffs. Are the attorneys in the case claiming that it is too early to mediate? Ask them what they need to be ready, then get them what they need. Eliminate their excuses. Is your client afraid that broaching settlement will send the wrong message? Assure them that it has to be done at some point, and the earlier the better. They control what is offered, and clear messages can be given to the other parties to avoid confusion or adverse inferences. Do certain parties have unrealistic expectations or is someone in denial about the case? High stakes cases rarely settle quickly and often require several formal mediations to resolve. Identify who is unrealistic, then select a mediator who can best educate them. The first mediation is often a great tool to enlighten or educate parties. Are there egos in the case that are preventing successful settlement discussions? Find a judge or mediator who can check egos at the door. C. Create Pressure/Leverage We work in a busy profession where it is hard to capture and maintain the attention of others. The best way to do that is to create pressure. Filing motions for summary judgment, motions to dismiss, early motions in limine, motions to strike, motions to exclude or taking rulings up on mandamus are great ways to force counsel to pay attention to the case and also help to narrow the issues at hand. Often just having these motions pending creates a sense of the unknown during negotiations which, in turn, provokes people to resolve cases in order to avoid a potential adverse ruling. File offers of judgment, proposals for settlement or other statutory offers that place pressure and risk on the other parties. Always negotiate issues in advance of negotiating numbers. Try to work out any outstanding legal issues before talking numbers. If you reach an impasse because Plaintiff thinks that one cap applies while the defendants think another cap applies, offer to arbitrate the issue of which cap applies. Sometimes simply offering to arbitrate a disputed legal issue moves one of the parties off center. Likewise with apportionment. Offer to arbitrate or even mediate apportionment among the defendants well before you enter mediation with Plaintiffs. Address consent issues, reservations of rights or insolvency issues ahead of time. If you have tentative consent to settle that may be withdrawn as time goes by, use that to your advantage to get talks started. If Plaintiffs counsel is focusing on claims or issues that are subject to a reservation of rights, remind them that there is no insurance for those issues so that they can shift their focus elsewhere and prepare their clients accordingly. If your client has no assets and/or limited insurance, disclose it ahead of time to create pressure between the parties who want money and those who actually have money. V. Negotiation Tactics A. Credibility The most important thing that you can do when negotiating is to gain, then maintain, credibility. Your prep work and how you present the opening offer set the tone. Know the strengths of the entire case, but more importantly, know the weaknesses and be willing to concede them when necessary. There are occasions when you may need to concede liability and doing so can take the wind out of the other parties sails. Establish a common ground with the parties. Be an active listener to identify commonalities, no matter how small. Remember, you are working everyone toward the middle so don t just focus on you versus the plaintiff. Be principled and always remain professional. Never get hung up on the demand because negotiations will always stall if you do. The demand is almost always unrealistic, so expect it and prepare your client to expect it. Negotiate to your number and negotiate your own case. Do not let others move your case in a 110 Medical Liability and Health Care Law March 2013

103 direction that is outside of your control. Stay open minded throughout the process and constantly re-evaluate your case based on what you have learned. B. Use the Mediator Use your mediator as the paid experts that they are. Ask their opinions and recommendations about the case as a whole. Learn as much as you can from what other parties disclose to them. Have the mediator explain or mediate disputed issues of law or fact among the parties. Have them make mediator s proposals if you get the impression that their number is realistic. Make your mediator work and continue to use them after mediation has concluded. However, remember that you are sharing this paid expert with all of the parties, so be cautious with what you share. Do not rely on the mediator or let them posture your case for you. Most mediators are excellent, but no one knows the case as well as you do and much like , there is a lot lost in translation. Everyone has their own agenda and their own history, including the mediator. Sometimes this is helpful and sometimes it is damaging. The only way to prevent damage is to maintain direct communication between the parties. Do not let the mediator separate you from the other parties or replace you as your client s advocate. Talk directly to the other attorneys and their clients (both Plaintiff and defense). Aside from depositions, mediation is your only time to establish a rapport with the parties and talk directly to them, so make the most of it. Always show them the respect that they deserve and talk to them, not at or about them. C. Resolving Apportionment Do not impasse over apportionment. If you cannot agree to disagree, make your own offer. Doing so will often provoke a stubborn co-defendant to step up. Don t let your client get frustrated if a co-defendant continues to base their offers on a percentage of yours. That is their game, not yours, and over time the mediator and Plaintiffs counsel will tire of it. Solicit a separate demand if co-defendants get hung up on who is going to pay what percentage. You will create good will with Plaintiffs and move your case forward. Get creative if Plaintiffs won t provide separate demands. We had a case with 20 defendants whose lawyers and adjusters wasted an entire mediation fighting over apportionment. Toward the end of the day not a single offer had been made. The mediator gave us each a sheet of paper with all of the parties listed, and we were told to honestly and fairly apportion liability, including our own. We were also told to write a single, reasonable settlement figure. The plaintiff was told to do the same. The mediator took the 21 sheets and averaged the numbers for each party as well as the settlement figures. All 20 defendants were satisfied with the total settlement figure, and ultimately so was the plaintiff. However, 19 of the 20 defendants were satisfied with the apportionment. Plaintiff s counsel agreed to settle with the 19 of us for our agreed shares which created panic in the hold-out defendant who had the highest apportionment. The hold-out s carrier ultimately settled for their share the next day. Tactics like this move people off center and move negotiations forward. D. Difficult Parties Use difficult parties to your advantage. Don t play their game and do not engage at their level. Give them an opportunity to play with the group but if they refuse, team up against them, if necessary. Use their defiance to show Plaintiffs that you are acting in good faith. Chances are if they are being difficult with you, then they have been difficult with Plaintiffs counsel who may be interested in cutting a deal to spite the surly party. Settling the High Stakes Case Evans 111

104 Most defendants do not want to be the last party standing, particularly in high stakes cases. Discuss high/low agreements with Plaintiffs counsel. It makes co-defendants nervous to know or suspect that you might be protected and they are not. Consider having a special master or guardian ad litem appointed or asking the judge to assign the case to a magistrate to mediate. Parties often become more agreeable when facing a third party or magistrate who works for the judge who will be trying the case. E. Non-Monetary Offers Non-monetary offers will have little to no effect on the front end of negotiating a high stakes case. It is best to save those offers for when you need to bridge a narrow gap at the end of the day, as they have the most impact when parties are worn out or tired. Examples include an apology, a personal meeting with facility executives, having staff watch a day in the life video of the patient, educational seminars, honorariums/ memorials, changes in policies and procedures, reporting practitioners to the state board, adjusting unrelated balances owed and offering to use some of the settlement funds to endow a scholarship or donation in the name of the patient. F. Remain Persistent & Patient Persistence really does pay off, particularly so in the high stakes case because the demands are usually significant. No matter how far apart you are or how frustrated or belligerent everyone becomes, you will eventually come together. Actively listen both to what is being said and, more importantly, to what is not being said. That is usually where you will find a weakness or room for leverage. Determine who has the power in each room and figure out who needs the power, then patiently work to redistribute it and be prepared to concede your own power when necessary. While negotiations can be like herding cats, those who succeed are those who not only stay focused but who are able to keep others focused as well. No matter how many times an attorney tells you that they are not going to budge from a $30M demand, everyone has a Plan B, and often a Plan C. The trick is to chip away at them so that they eventually move off center. VI. Conclusion What really settles cases? Risk! You have to evaluate your own risk with intellectual honesty, and you have to create risk for others. If there is limited risk, there is no incentive for parties to give you what you want or need. Make people nervous because nervous people seek out support and confidence. It is all about managing your clients risk and creating risk for others. The key to both is clear, consistent communication and preparedness. High stakes cases rarely settle quickly, but they always settle with a lot of hard work and communication. 112 Medical Liability and Health Care Law March 2013

105 Pitfalls of the Well Baby Nursery: Procedures for Avoiding Disaster Bradley B. Stancombe, M.D. Director of Neonatology, Gateway Medical Center 651 Dunlop Lane Clarksville, TN (931)

106 Bradley B. Stancombe, M.D., is a full time board certified clinical neonatologist and is Director of Neonatology at Gateway Medical Center in Clarksville, Tennessee. He graduated from Baylor College of Medicine in 1984 and did a pediatric residency and neonatology fellowship in the U.S. Air Force. He left the Air Force in 1996 as a Lt Col to run the Gateway Level 2B NICU and serves as an associate professor of pediatrics at Vanderbilt University. Dr. Stancombe works closely with many community obstetricians and pediatricians to optimize newborn care and outcomes. He specializes in mid to late preterm and term newborn intensive care and continues to be involved in multiple quality improvement and risk reduction projects.

107 Pitfalls of the Well Baby Nursery: Procedures for Avoiding Disaster Table of Contents I. Presentation Pitfalls of the Well Baby Nursery: Procedures for Avoiding Disaster Stancombe 115

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109 Pitfalls of the Well Baby Nursery: Procedures for Avoiding Disaster I. Presentation Currently, there are over four million live births per year in the United States. These births occur in small community hospitals to large academic medical centers with varying levels of resources, personnel training and experience. The physicians themselves caring for these infants also come from very diverse backgrounds and may have years or just months in clinical practice prior to being confronted with a seemingly normal newborn at less than 2 days of age that is awaiting discharge. Much needs to occur physiologically in the first 48 hours of life to include conversion from fetal circulation to adult circulation, cardiopulmonary stabilization with lung expansion, thermoregulation, and establishment of adequate feedings. In addition, any problems related to the pregnancy or delivery itself must be resolved to include potential sepsis, hypoglycemia especially seen in the new epidemic of infants of diabetics, polycythemia or anemia, and birth related injuries. Obvious newborn malformations must also be evaluated, some of which if not treated quickly could lead to long term disabilities. All this is frequently done in less than 48 hours with increasing pressure from parents, insurance companies, and the health care system to discharge healthy newborns even sooner. Social workers are strained to the limits to assist with establishing a safe home environment and to enable the newborn to be able to return for timely outpatient physician follow up. Teenage parents, unsupported single mothers, poverty, drug abuse, and minimal family assistance only make matters worse. It is thus apparent that many things must come together to hopefully insure a safe newborn discharge in the first few days of life. Unfortunately at the time of discharge, there may perhaps be only subtle signs of an impending major clinical problem that if missed or ignored could lead to severe long-term morbidity or even death. The time of discharge is therefore critical in that with longer stays, evidence of a significant disease process usually becomes increasingly apparent. Early newborn discharge became more common in the 1990 s prompting the American Academy of Pediatrics to publish a statement in 1995 by the Committee on Fetus and Newborn regarding length of hospital stays for healthy term newborns (Pediatrics 1995; 96; 788). They discuss the inappropriate financial pressure now driving newborn discharges and established a set of conditions that should be met for safe newborn discharge. They define a short hospital stay for term newborns (38-42 weeks gestation) as discharge at less than 48 hours of age. The committee further states that it is unlikely that fulfillment of these criteria and conditions can be accomplished in less than 48 hrs. In addition, it is essential that all infants having a short hospital stay be examined by experienced health care providers within 48 hours of discharge. Early discharge became such a contentious issue that in 1996, the federal Newborns and Mothers Health Protection Act was passed, mandating insurers to cover hospitalization for at least 48 hours after vaginal delivery. Various state mandates were also enacted. The AAP early discharge policy was revised in 2004 with few changes and in 2010 with a change in definition of term to weeks and with some loosening of follow up recommendations to allow visits up to 72 hours after discharge (Pediatrics 2010; 125; 405). Early newborn discharge continues to be a source of controversy, yet it remains a common practice and is a major source of potential liability for both hospitals and practitioners. Three frequently subtle life-threatening conditions will be discussed in this paper to include keys to diagnosis and most importantly follow up so as to promote a good outcome and avoid legal liability for the practitioner and hospital. This presentation is not meant to be an in depth clinical discussion of disease, but will instead emphasize in general the medical importance and potential for significant morbidity and liability seen in these not uncommon problems. These conditions Pitfalls of the Well Baby Nursery: Procedures for Avoiding Disaster Stancombe 117

110 include pathologic newborn jaundice that can lead to bilirubin encephalopathy and kernicterus, sepsis, and critical but not always readily apparent congenital heart disease. Jaundice remains one of the most common conditions effecting newborns with over 60 percent demonstrating readily visible jaundice in the first week of life. Jaundice is clinically apparent as a yellow discoloration of a newborn s skin or sclera caused by an elevation of lipid-soluble bilirubin in the tissues. It is easier to detect visually in anemic and light skinned babies and thus may not be detected until at higher levels in darker skinned newborns. Babies are born with higher hematocrits than seen in adults in order to give them a greater oxygen carrying capacity as a compensation for lower oxygen saturations in utero. This process could even lead to polycythemia, generally defined as a hematocrit >65 that occurs in 1-5 percent of term newborns with a higher incidence at high altitude locations. Higher hematocrit levels lead to higher viscosity of the blood much like old oil in a car. This causes the heart to work harder and the thickened blood may act like sludge in the peripheral circulation. After birth in normal newborns with a much improved oxygen saturation of the blood, extra red cells are eliminated, as they are no longer needed thus reducing blood viscosity. Ultimately the hemoglobin in the red cells is degraded to bilirubin, which being fat-soluble, is carried by albumin in the blood to the liver to be metabolized. If bilirubin levels or rate of production are so elevated that they overwhelm the liver s capability of excreting the bilirubin, then tissue deposition occurs. The liver has to uptake the bilirubin, conjugate it to form water-soluble bilirubin glucuronide, and then move it in bile to the intestine where it is then converted by intestinal bacteria to the nonresorbable stercobilinogen that is finally excreted. Factors increasing newborn bilirubin levels include an increased red cell volume, a shorter red cell life, ineffective red cell production with heme breakdown, a decreased ability by liver cells to uptake, conjugate, and excrete bilirubin, and an increased uptake of bilirubin glucuronide from the intestines prior to bacterial conversion. These factors then all act together to produce a normal or expected degree of jaundice for term newborns. This is called physiologic jaundice of the newborn. The National Collaborative Perinatal project from looked at jaundice levels in 35,000 infants >2500 grams and found that the average term baby peaked in jaundice at day of life 3 with a level of 6-8 mg/dl of bilirubin with the 95 percent being 12.9 mg/dl. At this time however, only percent of mothers were breast feeding. Subsequent studies did show that breast fed babies tend to peak higher with the 95 percent being closer to 15mg/dl. The body seems to handle these bilirubin levels very well without significant obvious adverse effects to tissues. The problem comes when jaundice is no longer at normal physiologic levels, but rises to pathologic levels that can produce substantial brain injuries as the fat-soluble bilirubin is deposited in the brain. High levels lead to actual bilirubin staining of the brain that is usually most severe in the basal ganglia and cranial nerve and brainstem nuclei. This is called kernicterus and is seen clinically in four stages. Initially there is poor tone and feeding with a high-pitched cry. This can progress to seizures, fever, or death, an interim period of hyper then hypotonia, and late effects include athetoid cerebral palsy, deafness, and possibly mental retardation. Early discharges may occur before an alarming rise in bilirubin is obvious, and even with readily available early follow up, irreversible major damage could have already occurred. Three common conditions are frequently identified as sources of early onset pathologic jaundice. They include sepsis, hemolysis-more rapid breakdown of blood, and TORCH infections. Hemolysis however is most responsible for cases of bilirubin induced brain damage and is largely due to blood type incompatibilities, but also seen with red cell enzyme deficiencies and other red cell anomalies. Rapid rates of red cell breakdown can easily overwhelm the liver s ability to excrete bilirubin and bilirubin serum levels quickly rise with subsequent bilirubin staining of the brain. Rh incompatibility used to be a huge problem prior to routine rhogam use in Rh-negative mothers. In this situation, mothers are Rh negative, but have an Rh-positive baby. The mother can be sensitized to an Rh-positive newborn s cells possibly from a previous pregnancy or transfusion 118 Medical Liability and Health Care Law March 2013

111 of fetal cells into the maternal circulation with the current pregnancy. This produces an antibody response by the mother that actually crosses the placenta and breaks down some of the baby s red cells making them anemic and jaundiced. Bilirubin levels rise rapidly after birth. ABO incompatibility can do the same thing with an O mother having and A or B baby, but the hemolysis usually is less severe. It was significant hemolysis from blood incompatibilities that was historically most responsible for bilirubin brain damage or kernicterus and effectively recognized and treated by practitioners with phototherapy and exchange transfusions to keep bilirubin levels less than 20mg/dl prior to a reemergence of kernicterus in the 1990 s. This reemergence was associated with early discharges, the breast feeding boom, and an overall much more relaxed approach to jaundice in general by practitioners as jaundice was not as severe as in the Rh babies of the past, and no one wanted to overact to the normal physiologic jaundice that might adversely effect the very important benefits of breast feeding. Breast fed babies are at increased risk for higher bilirubin levels due to initial caloric deprivation with calories needed to stimulate liver function and gut motility, dehydration, increased reabsorption of bilirubin glucuronide from the gut due to delayed passage of stools, increased enzyme activity in breast milk that could break down the conjugated bilirubin glucuronide back to free bilirubin, and other factors involved in later true breast milk jaundice. It is severe jaundice associated with breast feeding in otherwise normal term newborns that has become the new nightmare for practitioners. As increasing cases of severe kernicterus were seen in the 1990 s, a kernicterus registry was started and alarmingly showed that many of the cases were in otherwise healthy breast fed babies and many of the rest were also in breast fed babies with one other problem to include hemolysis, excessive bruising, sepsis, or G6PD deficiency of the red cell. Most had bilirubin levels > 30 mg/dl and severe brain injury. With over 90 cases registered, a JCAHO sentinel event alert was published in 2001 to alert hospitals and practitioners of the reemergence of kernicterus. The AAP reacted quickly and published a clinical practice guideline in 2004 regarding the management of hyperbilirubinemia in the newborn infant 35 or more weeks of gestation (Pediatrics 2004; 114; 297). This guideline emphasized the importance of identifying infants with risk factors for severe hyperbilirubinemia, plotting serial bilirubin levels on age graphs to determine phototherapy needs, defining risk zones at discharge for infants that might need closer follow up, and outlined the need for education by both hospitals and practitioners regarding jaundice and the need for timely outpatient follow up. In addition, it was made clear that term infants who are clinically jaundiced at <24 hrs are not considered healthy and need a full evaluation. They also suggested a discharge bilirubin or transcutaneous measurement be done and plotted on the risk graph, as a means of identifying higher risk babies other than just using unreliable visual assessment of jaundice or identifying risk factors only. With a growing number of legal actions in kernicterus cases not initially identified as high risk in the nursery, practitioners are becoming more aware of the problem. Office staff need to be educated as well so that inappropriate telephone advice is not given to anxious breast feeding moms with a jaundiced baby who is sleepy and not feeding well. It is an obvious tragedy when an otherwise healthy term baby develops preventable permanent brain injury from exaggerated hyperbilirubinemia that was not treated in time. Newborn sepsis remains a complex and life-threatening problem in the term nursery and is another major pitfall to all practitioners. Although risk factors can be identified from prenatal records, and the actual events of labor, serial observation of temperature status, cardiorespiratory function, feeding, color, and alertness are key to identifying a potentially septic baby. Since hospital personnel are in frequent contact with the newborn, they play a very important role in catching signs of sepsis, but with only a daily brief visit to the nursery by most practitioners, these providers must be hyperalert to any signs or symptoms associated with newborn sepsis and respond quickly. Newborn sepsis can be bacterial, viral, or fungal, but most life threatening sepsis seen in the term nursery is bacterial with Group B Streptococcal disease (GBS) being the most sig- Pitfalls of the Well Baby Nursery: Procedures for Avoiding Disaster Stancombe 119

112 nificant pathogen since the 1970 s though other pathogens are starting to emerge including E Coli and MRSA. There has been a concerted effort by the CDC, AAP, and ACOG-American College of Obstetricians and Gynecologists to reduce GBS sepsis in newborns. Early onset GBS sepsis (at 7 days or less) has declined significantly since the early 1990 s from about 1.7 cases per 1000 live births to about.34 to.37 cases per 1000 births in recent years (CDC MMWR 2010 Vol. 59 RR-10). This has been done through provider education, antenatal GBS screening, as well as intrapartum antibiotic prophylaxis for culture positive and high-risk women. This recent CDC guideline clearly outlines the intrapartum as well as term nursery process for the steps in attempting to prevent GBS sepsis and was again endorsed by the AAP regarding newborns. These steps answer questions like what to do with the newborn of a GBS positive mother who did not receive adequate intrapartum antibiotics? This leaves little room for noncompliance by the hospital or practitioner. Unfortunately despite all efforts to eliminate GBS sepsis, it still occurs with a maternal colonization rate up to 30 percent. Many recent cases have occurred in GBS negative mothers who then did not receive intrapartum antibiotics, so we must assume that the maternal culture was a false negative or that the mom was colonized later than the usual culture time of weeks. The negative maternal status can lead to a false sense of security by the practitioner so it again remains key to not ignore any clinical signs of sepsis and get appropriate lab work if there are any concerns. Also cases are occurring with minimal rupture time of maternal membranes. Most truly septic newborns present in the first hours of life with symptoms of bacteremia or pneumonia that may lead to meningitis, which is more common in late onset GBS disease (>7 days). In addition it is vital to get antibiotics started as soon as possible in suspected sepsis since GBS bacterial doubling time can be very fast. Newborns are commonly screened for sepsis with a complete blood count (CBC) and manual differential of the white blood cells. Neutropenia (neutrophils<1000/mcl and a high immature to total neutrophil ratio (>.3) are both concerning for sepsis and cannot be ignored. If labs are checked due to some concern over clinical symptoms and they are abnormal, failure to act on the lab invites legal risk and a poor outcome. A CXR should be obtained if there are any respiratory symptoms. Some practitioners also obtain a C reactive protein as a nonspecific sign of inflammation and infection. If in doubt, obtain a blood culture and admit and treat with IV antibiotics for at least 48 hours pending clinical signs and symptoms and blood culture results. Early treatment has resulted in much improved outcomes, whereas treatment delay can lead to significant morbidity and mortality especially if the sepsis progresses to meningitis. Babies discharged at 24 hours may not yet exhibit signs of sepsis and could rapidly deteriorate at home in the next few days. Congenital heart disease remains a common surprise to practitioners in the term nursery and despite prenatal ultrasounds; many heart conditions are not diagnosed until after birth. A cyanotic infant with a loud murmur who is obviously in trouble is usually moved quickly to the NICU, but physiologic transient heart murmurs are frequently heard in the term nursery and are not initially a cause for alarm. Also, significant heart disease can be present without a heart murmur or cyanosis. It is up to the practitioner to decide which murmurs or clinical signs could indicate a more severe cardiac condition that requires intervention. Many infants have had subtle murmurs, or decreased lower extremity arterial pulses, or mild decreased perfusion that easily could be missed at 24 or even 48 hours, but the conditions causing these signs could be life threatening shortly thereafter. According to the CDC, congenital heart defects account for up to 24 percent of infant deaths due to birth defects. About 1 per 1000 babies is born with a critical congenital heart defect (CCHD) while 8 per 1000 have some form of congenital heart disease including the common small ventricular septal defects or atrial septal defects that usually cause no major problems in the initial term newborn timeframe. CCHD s are life threatening and many are effectively treated if diagnosed in a timely manner. The ductal dependent lesions are especially time critical in that as the baby converts from fetal to adult circulation and closes a vessel called the ductus arteriosus, flow to the lungs or body could be cut off with rapid subsequent 120 Medical Liability and Health Care Law March 2013

113 deterioration. This vessel closure usually occurs in term babies by day 2 to 3 so again this is another critical event in the first 72 hrs of a newborn. With quick recognition and infusion of prostaglandin E1, the ductus can be medically reopened with blood flow restored until more definitive surgical correction is available. In an effort to detect these lesions prior to discharge, in Sept of 2011, the Secretary of Health and Human Services recommended that screening for CCHD be added to the other uniform newborn screening tests through a pulse oximetry test after 24 hrs of age and prior to discharge. The AAP endorsed this recommendation and advised that if the test shows abnormally low oxygen saturation levels than other causes of hypoxemia should be excluded and a diagnostic echocardiogram obtained (Pediatrics 2012; 129; 190). It is up to the states as to how they wish to incorporate this recommendation into their own screening programs. The need to obtain an echo may be problematic for smaller hospitals without that capability and will involve transfer of newborns for the test that will have some false positives. Seven specific CCHD s are targeted by this test, but others may be detected as well. Tennessee has joined other states in mandating that this test be performed on all newborns and it is required in Tennessee as of January 1, Again, this test will not pick up all disease and the earlier the discharge, the more likely a critical lesion could be missed. This brief paper has discussed only three of the many potential life threatening problems that could be encountered on any given day in the normal term nursery. Parents are not aware that much has to occur physiologically in the first 72 hours and that their practitioner is forced to evaluate and anticipate many potential problems despite pressure from all directions to discharge as soon as possible. Regardless, it is essential that once discharged, early outpatient follow up be obtained as an added safety measure to diagnose life threatening issues that may have been only subtle or not yet apparent in the term nursery. Hospitals are also experiencing increased liability in these areas and many are promoting bilirubin education and screening, educating staff in signs of sepsis, and starting pulse oximetry screening. With minimal practitioner contact with the normal newborn, it is definitely a team process to identify those newborns with potentially serious early problems as well as to document clearly that appropriate teaching has occurred and that a safe discharge environment with readily available follow up is obtained. Staff should also be encouraged to utilize a neonatal nurse practitioner or neonatologist in a nearby NICU whenever doubts arise over unclear clinical conditions. Unlike practitioners returning to busy clinics, NICU staff have the advantage of being able to provide frequent serial exams that may clarify more subtle impending disasters, with the ultimate goal of obtaining excellent outcomes for all newborns. Pitfalls of the Well Baby Nursery: Procedures for Avoiding Disaster Stancombe 121

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115 Ethics and Professionalism for Litigators Walter W. Billy Bates Starnes Davis Florie LLP 100 Brookwood Place, 7th Floor P.O. Box Birmingham, AL (205)

116 Walter W. Billy Bates is the managing partner of Starnes Davis Florie LLP in Birmingham, Alabama. His practice is devoted to the defense of health care professionals and facilities, as well as commercial litigation. Mr. Bates has tried numerous civil cases to a jury verdict on behalf of product manufacturers, physicians, hospitals and corporations. He is a fellow in the American College of Trial Lawyers, a diplomate of the American Board of Trial Advocates and a past president of its Alabama chapter.

117 Ethics and Professionalism for Litigators Table of Contents Presentation Ethics and Professionalism for Litigators Bates 125

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119 Presentation CODE OF PRETRIAL AND TRIAL CONDUCT Permission to reprint Code of Pretrial and Trial Conduct in its entirety has been granted by the American College of Trial Lawyers. Ethics and Professionalism for Litigators Bates 127

120 Please accept this copy of the Code of Pretrial and Trial Conduct published by the American College of Trial Lawyers. The development of this Code by the Fellows of the College and its distribution to persons and institutions engaged in all aspects of the administration of justice represents an important part of the execution of the College s mandate to improve and elevate standards of trial practice, the administration of justice and the ethics of the profession. The American College of Trial Lawyers, founded in 1950, is composed of the best of the trial bar from the United States and Canada. Fellowship in the College is extended by invitation only, after careful investigation, to those experienced trial lawyers who have mastered the art of advocacy and whose professional careers have been marked by the highest standards of ethical conduct, professionalism, civility and collegiality. Lawyers must have a minimum of 15 years experience before they can be considered for Fellowship. Membership in the College cannot exceed 1% of the total lawyer population of any state or province. Fellows are carefully selected from among those who represent plaintiffs and those who represent defendants in civil cases; those who prosecute and those who defend persons accused of crime. The College is thus able to speak with a balanced voice on important issues affecting the administration of justice. The College is confident that utilization of this Code in the course of legal proceedings in the courts and as a teaching aid at the Bar and in the nation s law schools will represent a positive contribution to improving and elevating standards of trial practice, the administration of justice and the ethics of the profession. NATIONAL OFFICE MacArthur Blvd. Suite 610 Irvine, CA t: f: Medical Liability and Health Care Law March 2013

121 Message from the Chief Justice of the United States For more than fifty years, the American College of Trial Lawyers has promoted professionalism in the conduct of trial litigation. Its authoritative Code of Trial Conduct, first published in 1956, has served as an enduring landmark in the development of professional standards for advocates. The College continues those efforts through the publication of its revised and enlarged Code of Pretrial and Trial Conduct. This comprehensive resource sets out aspirational principles to guide litigators in all aspects of their work as advocates of client interests. The Code looks beyond the minimum ethical requirements that every lawyer must follow and instead identifies those practices that elevate the profession and contribute to fairness in the administration of justice. As Justice Frankfurter noted, An attorney actively engaged in the conduct of a trial is not merely another citizen. He is an intimate and trusted and essential part of the machinery of justice, an officer of the court in the most compelling sense. I encourage lawyers who engage in trial work to observe and advance the principles that the College has set forth in this volume. I commend the American College of Trial Lawyers for its leadership in defining and refining the standards of professionalism that are vital to our system of justice. John G. Roberts, Jr. Chief Justice of the United States Ethics and Professionalism for Litigators Bates 129

122 I hold every man a debtor to his profession; from the which, as men of course do seek to receive countenance and profit, so ought they of duty to endeavor themselves, by way of amends, to be a help and ornament thereto. Sir Francis Bacon 130 Medical Liability and Health Care Law March 2013

123 AmericAn college of TriAl lawyers CODE OF PRETRIAL AND TRIAL CONDUCT Approved by the Board of Regents, June 2009 Copyright 2009 American College of Trial Lawyers All Rights Reserved Ethics and Professionalism for Litigators Bates 131

124 Table of Contents Page Forward...1 Preamble...2 Qualities.of.a.Trial.Lawyer...3 Obligations.to.Clients...3 Obligations.to.Colleagues...4 Obligations.to.the.Court...4 Obligations.to.the.System.of.Justice...5 Motions.and.Pretrial.Procedure...6 Discovery...8 Relationships.with.Witnesses.and.Litigants...9 Trial CODE OF PRETRIAL AND TRIAL CONDUCT 132 Medical Liability and Health Care Law March 2013

125 Forward The Legal Ethics and Professionalism Committee of the American College of Trial Lawyers (the College ) is charged with the following mandate: To advance, improve, and promote ethical standards and professionalism in the trial bar in all its aspects in both the United States and Canada as well as to engage in such other activities as may be directed by the Board of Regents. All jurisdictions have codes of conduct that prescribe minimum standards for disciplinary purposes. There is no need here to duplicate such standards. This ACTL Code represents an attempt by the College to set down aspirational, rather than minimal, guidelines for trial lawyers and judges. The problem in trial practice today is not that lawyers violate the ethical rules, although some lawyers do. Most lawyers know the rules and try to comply. The real problem is the gradual corrosion of the profession s traditional aspirations, which are: Honor for values such as honesty, respect and courtesy toward litigants, opposing advocates and the court; A distaste for meanness, sharp practice, and unnecessarily aggressive behavior; Engagement in public service; A focus on the efficient, fair preparation and trial of cases; and A role as agent for counseling and for the resolution of disputes. Despite what the profession says, the profession often acts as if these values are inconsistent with effective advocacy in an adversary system of justice. The College is uniquely positioned to lead the way in changing these attitudes because it strives to offer Fellowship only to those lawyers who embody the skill and values to which they and the profession should aspire. The College cannot lead by focusing on the lowest floor of acceptable behavior. The College sees the new code as one that can be endorsed by courts, that can be profitably used in training programs by law schools and bar organizations, and that describes the values that the Fellows of the American College of Trial Lawyers endorse and practice daily. The new Code of Pretrial and Trial Conduct is a product that the College believes can be endorsed by courts and the profession as articulating the level of conduct to which all members of our profession should aspire. If trial lawyers practice these principles the profession will begin a process of change that benefits lawyers, litigants, and our system of justice. CODE OF PRETRIAL AND TRIAL CONDUCT 1 Ethics and Professionalism for Litigators Bates 133

126 Preamble Admission to the Bar is a high honor, and those lawyers who devote their lives to presenting cases in the courts are truly privileged. Trial lawyers are officers of the court. They are entrusted with a central role in the administration of justice in our society necessary to democracy. Lawyers who engage in trial work have a special responsibility to strive for prompt, efficient, ethical, fair and just disposition of litigation. The American College of Trial Lawyers believes that, as officers of the court, trial lawyers must conduct themselves in a manner that reflects the dignity, fairness, and seriousness of purpose of the system of justice they serve. They must be role models of skill, honesty, respect, courtesy, and fairness consistent with their obligations to the client and the court. Trial lawyers have a duty to conduct themselves so as to preserve the right to a fair trial, one of the most basic of all constitutional guarantees, while courageously, vigorously and diligently representing their clients and applying the relevant legal principles to the facts as found. Without courtesy, fairness, candor, and order in the pretrial process and in the courtroom, reason cannot prevail and constitutional rights to justice, liberty, freedom and equality under law will be jeopardized. The dignity, decorum and courtesy that have traditionally characterized the courts are not empty formalities. They are essential to an atmosphere in which justice can be done. No client, corporate or individual, however powerful, nor any cause, civil, criminal or political, however important, is entitled to receive, nor should any lawyer render, any service or advice encouraging or inviting disrespect of the law or of the judicial office. No lawyer may sanction or invite corruption of any person exercising a public office or private trust. No lawyer may condone in any way deception or betrayal of the court, fellow members of the Bar, or the public. A lawyer advances the honor of the profession and the best interests of the client when a lawyer embodies and encourages an honest and proper respect for the law, its institutions and officers. Above all, a lawyer finds the highest honor in a deserved reputation as an officer for justice, faithful to private trust and to public duty, and as an honest person. This Code of Pretrial and Trial Conduct ( the Code ) is not intended to supplant any local rules, procedural rules, or rules of professional conduct. This Code aims to provide aspirational guidance for trial lawyers. It sets forth a standard above the ethical minimum a standard of conduct worthy of the privileges and responsibilities conferred on those who have sworn to serve our system of justice. This Code is intended to provide guidance for a lawyer s professional conduct except insofar as the applicable law, code or rules of professional conduct in a particular jurisdiction require otherwise. It is an aspirational guide for trial lawyers and should not give rise to a cause of action or sanction, create a presumption that a legal duty has been breached or form the basis for disciplinary proceedings not created under the applicable law, court rules or rules of professional conduct. CODE OF PRETRIAL AND TRIAL CONDUCT Medical Liability and Health Care Law March 2013

127 CODE OF PRETRIAL AND TRIAL CONDUCT Qualities of a Trial Lawyer Trial lawyers are officers of the court. They are entrusted with a central role in the administration of justice in our society. Lawyers who engage in trial work have a special responsibility to strive for prompt, efficient, ethical, fair and just disposition of litigation. Honesty, Competence and Diligence (a) A lawyer must in all professional conduct be honest, candid and fair. (b) A lawyer must possess and apply the legal knowledge, skill, thoroughness and preparation necessary for excellent representation. (c) A lawyer must diligently, punctually and efficiently discharge the duties required by the representation in a manner consistent with the legitimate interests of the client. Obligations to Clients A lawyer must provide a client undivided allegiance, good counsel and candor; the utmost application of the lawyer s learning, skill and industry; and the employment of all appropriate means within the law to protect and enforce legitimate interests of a client. A lawyer may never be influenced directly or indirectly by any consideration of self-interest. A lawyer has an obligation to undertake unpopular causes if necessary to ensure justice. A lawyer must maintain an appropriate professional distance in advising his or her client, in order to provide the greatest wisdom. Employment and Withdrawal (a) It is the right of a lawyer to accept employment in any civil case unless such employment is or would likely result in a violation of the rules of professional responsibility, a rule of court or applicable law. It is the lawyer s right and duty to take all proper actions and steps to preserve and protect the legal merits of the client s position and claims, and the lawyer should not decline employment in a case on the basis of the unpopularity of the client s cause or position. (b) The right of a person accused of a crime to be represented by competent counsel is essential to our system of justice. A lawyer should not decline such representation because of the lawyer s personal or the community s opinion of the guilt of the accused or heinousness of the crime. A lawyer must raise all defenses and arguments that should be asserted on the client s behalf. Fidelity to the Client s Interests A lawyer must not permit considerations of personal or organizational advancement, financial gain, favor with other persons, or other improper considerations to influence the representation of the client. CODE OF PRETRIAL AND TRIAL CONDUCT 3 Ethics and Professionalism for Litigators Bates 135

128 Obligations to Colleagues A lawyer should be straightforward and courteous with colleagues. A lawyer should be cooperative with other counsel while zealously representing the client. A lawyer must be scrupulous in observing agreements with other lawyers. Relations with Other Counsel (a) A lawyer must be courteous and honest when dealing with opposing counsel. (b) A lawyer should not make disparaging personal remarks or display acrimony toward opposing counsel, and must avoid demeaning or humiliating words in written and oral communication with adversaries. (c) When practicable and consistent with the client s legitimate interests and local custom, lawyers should agree to reasonable requests to waive procedural formalities. (d) The lawyer, and not the client, has the discretion to determine the customary accommodations to be granted opposing counsel in all matters not directly affecting the merits of the cause or prejudicing the client s rights. (e) A lawyer must adhere strictly to all written or oral promises to and agreements with opposing counsel, and should adhere in good faith to all agreements implied by the circumstances or by appropriate local custom. (f) Written communications with opposing counsel may record and confirm agreements and understandings, but must not be written to ascribe to any person a position that he or she has not taken or to create a record of events that have not occurred. Obligations to the Court Judges and lawyers each have obligations to the court they serve. A lawyer must be respectful, diligent, candid and punctual in all dealings with the judiciary. A lawyer has a duty to promote the dignity and independence of the judiciary, and protect it against unjust and improper criticism and attack. A judge has a corresponding obligation to respect the dignity and independence of the lawyer, who is also an officer of the court. Communication with the Court (a) A lawyer must always show courtesy to and respect for a presiding judge. While a lawyer may be cordial in communicating with a presiding judge in court or in chambers, the lawyer should never exhibit inappropriate familiarity. In social relations with members of the judiciary, a lawyer should take care to avoid any impropriety or appearance of impropriety. In making any communication about a judge, a lawyer should not express or imply that the lawyer has a special relationship or influence with the judge. (b) A lawyer should never make any attempt to obtain an advantage through improper ex parte communication with a judge or the staff in the judge s chambers. A lawyer must make every effort to avoid such communication on any substantive matter and any matter that could reasonably CODE OF PRETRIAL AND TRIAL CONDUCT Medical Liability and Health Care Law March 2013

129 be perceived as substantive, except as addressed in subpart (c) below. When a lawyer informally communicates with a court, the highest degree of professionalism is required. (c) If ex parte communication with the court is permitted by applicable rules of ethics and procedure, a lawyer must diligently attempt to notify opposing parties, through their counsel if known, unless genuine circumstances exist that would likely prejudice the client s rights if notice were given. When giving such notice, the lawyer should advise the opponent of the basis for seeking immediate relief and should make reasonable efforts to accommodate the opponent s schedule so that the party affected may be represented. (d) When possible, a lawyer s communications with the court related to a pending case should be in writing, and copies should be provided promptly to opposing counsel. When circumstances require oral communication with the court, a lawyer must notify opposing counsel of all such communications promptly. Independence and Impartiality of Judicial Officers and Neutrals (a) Judges, arbitrators, mediators and other neutrals must maintain their independence and impartiality. They must not allow professional or personal relationships, employment prospects or other improper considerations to influence or appear to influence the discharge of their duties. (b) A judge must promote the dignity and proper discharge of the duties of the lawyer, who is also an officer of the court entitled to respect and courtesy. Obligations to the System Of Justice A lawyer has an obligation to promote the resolution of cases with fairness, efficiency, courtesy, and justice. As an officer of the court and as an advocate in the court, a lawyer should strive to improve the system of justice and to maintain and to develop in others the highest standards of professional behavior. Devotion to the System of Public Justice A lawyer must strive at all times to uphold the honor and dignity of the profession. Every lawyer should contribute to the improvement of the system of justice and support those measures that enhance the efficiency, fairness and quality of justice dispensed by the courts. A lawyer should never manifest, or act upon, bias or prejudice toward any person based upon race, sex, religion, national origin, disability, age, sexual orientation or socioeconomic status. Pro Bono Publico A lawyer should personally render public interest legal service and support organizations that provide legal services to persons of limited means by contributing time and resources. Settlement and Alternative Dispute Resolution A lawyer must never be reluctant to take a meritorious case to trial if the dispute cannot otherwise be satisfactorily resolved. However, a lawyer must provide the client with alternatives to trial when to do so would be consistent with the client s best interests. A lawyer should educate clients early in the legal CODE OF PRETRIAL AND TRIAL CONDUCT 5 Ethics and Professionalism for Litigators Bates 137

130 process about various methods of resolving disputes without trial, including mediation, arbitration, and neutral case evaluation. Motions and Pretrial Procedure A lawyer has an obligation to cooperate with opposing counsel as a colleague in the preparation of the case for trial. Zealous representation of the client is not inconsistent with a collegial relationship with opposing counsel in service to the court. Motions and pretrial practice are often sources of friction among lawyers, which contributes to unnecessary cost and lack of collegiality in litigation. The absence of respect, cooperation, and collegiality displayed by one lawyer toward another too often breeds more of the same in a downward spiral. Lawyers have an obligation to avoid such conduct and to promote a respectful, collegial relationship with opposing counsel. Scheduling and Granting Extensions for Pretrial Events (a) A lawyer should schedule pretrial events cooperatively with other counsel as soon as the event can reasonably be anticipated. Lawyers scheduling an event should respect the legitimate obligations of colleagues and avoid disputes about the timing, location and manner of conducting the event. (b) A lawyer should seek to reschedule an event only if there is a legitimate reason for doing so and not for improper tactical reasons. A lawyer receiving a reasonable request to reschedule an event should make a sincere effort to accommodate the request unless the client s legitimate interests would be adversely affected. (c) Scheduling pretrial events and granting requests for extensions of time are properly within the discretion of the lawyer unless the client s interests would be adversely affected. A lawyer should counsel the client that cooperation among lawyers on scheduling is an important part of the pretrial process and expected by the court. A lawyer should not use the client s decision on scheduling as justification for the lawyer s position unless the client s legitimate interests are affected. Service of Process, Pleadings and Proposed Orders (a) The timing, manner, and place of filing, electronic filing or serving papers should never be calculated to delay, embarrass or improperly disadvantage the party being served. (b) Unless exigent circumstances require otherwise, papers filed in a court must be promptly served upon or made available to opposing parties or counsel. (c) Papers should not be served in a manner deliberately designed to unfairly shorten an opponent s time for response or to take other unfair advantage of an opponent. (d) Service must be made in a manner that affords an opposing party a fair and timely opportunity to respond, unless exigent circumstances legitimately require or applicable rules permit an ex parte application to the court or an abbreviated time for response. Motion Practice and Other Written Submissions to the Court (a) Before filing pretrial motions, lawyers should work together to resolve issues and to CODE OF PRETRIAL AND TRIAL CONDUCT Medical Liability and Health Care Law March 2013

131 identify matters not in dispute. When motions are necessary, lawyers should cooperate to facilitate the filing, service, and hearing of the motion. Orders submitted to the court must fairly and accurately reflect the requested or actual ruling of the court. (b) In written submissions and oral presentations, a lawyer should neither engage in ridicule nor sarcasm. Neither should a lawyer ever disparage the integrity, intelligence, morals, ethics, or personal behavior of an opposing party or counsel unless such matters are directly relevant under controlling law. (c) When documents or data are presented to the court, they must be furnished to opposing counsel in exactly the same format, including identical highlighting or other emphasis. Pretrial Conferences (a) A lawyer should seek to reach agreement with opposing counsel to limit the issues to be addressed before and during trial. (b) A lawyer should determine in advance of a pretrial conference the trial judge s custom and practices in conducting such conferences. (c) A lawyer should satisfy all directives of the court set forth in the order setting a pretrial conference and should consult and comply with all local rules and with any specific requirements of the trial judge unless properly challenged when based upon a belief of unfair prejudice to the client. (d) Before a pretrial conference, a lawyer should ascertain the willingness of the client (and the carrier if an insurer is involved) to participate in alternative dispute resolution. (e) Unless unavoidable circumstances prevent it, a lawyer representing a party at a pretrial conference must be thoroughly familiar with each aspect of the case, including the pleadings, the evidence, and all potential procedural and evidentiary issues. (f) A lawyer should alert the court as soon as practicable to scheduling conflicts of clients, experts, and witnesses. (g) If stipulations are possible for uncontested matters, a lawyer should propose specific stipulations and work with opposing counsel to obtain an agreement in advance of the pretrial conference. (h) In advance of a final pretrial conference, discovery should be completed, discovery responses should be supplemented, evidentiary depositions should be concluded, and settlement should be explored. (i) Unless unavoidable circumstances prevent it, the final pretrial conference should be attended by a lawyer who will actually try the case, and, in any event, by a lawyer who is familiar with the case. (j) At or before a final pretrial conference, a lawyer should alert the court to the need for any pretrial rulings, hearings on motions or other matters requiring action by the court in advance of trial. (k) At the final pretrial conference, a lawyer should be prepared to advise the court of the status of settlement negotiations and the likelihood of settlement before trial. CODE OF PRETRIAL AND TRIAL CONDUCT 7 Ethics and Professionalism for Litigators Bates 139

132 Discovery A lawyer must conduct discovery as a focused, efficient, and principled procedure to gather and preserve evidence in the pursuit of justice. Discourtesy, obfuscation, and gamesmanship have no proper place in this process. Discovery Practice (a) In discovery, as in all other professional matters, a lawyer s conduct must be honest, courteous, and fair. (1) A lawyer should conduct discovery efficiently to elicit relevant facts and evidence and not for an improper purpose, such as to harass, intimidate, unduly burden another party or a witness or to introduce unnecessary delay. Overly broad document requests should be avoided by focusing on clear materiality and a sense of cost/benefit. (2) A lawyer should respond to written discovery in a reasonable manner and should not interpret requests in a strained or unduly restrictive way in an effort to avoid responding or to conceal relevant, nonprivileged information. (3) Objections to interrogatories, requests for production, and requests for admissions must be made in good faith and must be adequately explained and limited in a manner that fairly apprises the adversary of the material in dispute and the bona fide grounds on which it is being withheld. (4) When a discovery dispute arises, opposing lawyers must attempt to resolve the dispute by working cooperatively together. Lawyers should refrain from filing motions to compel or for court intervention unless they have genuinely tried, but failed, to resolve the dispute through all reasonable avenues of compromise and resolution. (5) Lawyers should claim a privilege only in appropriate circumstances. They must not assert a privilege in an effort to withhold or to suppress unprivileged information or to limit or delay a response. (6) Requests for additional time to respond to discovery should be made as far in advance of the due date as reasonably possible and should not be used for tactical or strategic reasons. (7) Unless there are compelling reasons to deny a request for additional time to respond to discovery, an opposing lawyer should grant the request without necessitating court intervention. Compelling reasons to deny such a request exist only if the client s legitimate interests would be materially prejudiced by the proposed delay. (b) Depositions should be dignified, respectful proceedings for the discovery and preservation of evidence. (1) A lawyer should limit depositions to those that are necessary to develop the claims or defenses in the pending case or to perpetuate relevant testimony. (2) A lawyer should conduct a deposition with courtesy and decorum and must CODE OF PRETRIAL AND TRIAL CONDUCT Medical Liability and Health Care Law March 2013

133 never verbally abuse or harass the witness, engage in extended or discourteous colloquies with opposing counsel or unnecessarily prolong the deposition. (3) During a deposition, a lawyer must assert an objection only for a legitimate purpose. Objections must never be used to obstruct questioning, to communicate improperly with the witness, to intimidate, to harass the questioner or to disrupt the search for facts or evidence germane to the case. Relationships with Witnesses and Litigants A lawyer must treat all persons involved in a case with candor, courtesy and respect for their role and rights in the legal process. Communicating with Nonparty Fact Witnesses (a) A lawyer must carefully comply with all laws and rules of professional responsibility governing communications with persons and organizations with whom the lawyer does not have an attorney-client relationship. A lawyer must be especially circumspect in communications with nonparty fact witnesses who have a relationship to another party. (b) In dealing with a nonparty who is a fact witness or a potential fact witness, a lawyer must: (1) disclose the lawyer s interest or role in the pending matter and avoid misleading the witness about the lawyer s purpose or interest in the communication; (2) be truthful about the material facts and the applicable law; nonparty; (3) if the nonparty has no counsel, correct any misunderstanding expressed by the (4) treat the nonparty courteously; and (5) avoid unnecessarily embarrassing, inconveniencing or burdening the nonparty. (c) If a lawyer is informed that a nonparty fact witness is represented by counsel in the pending matter, the lawyer must not communicate with the witness concerning the pending litigation without permission from that counsel. (d) If communicating with a nonparty fact witness, the lawyer should be careful to avoid fostering any impression that the lawyer also represents that witness unless the lawyer does, in fact, represent the witness in compliance with the applicable rules of professional responsibility. (e) A lawyer should not obstruct another party s access to a nonparty fact witness or induce a nonparty fact witness to evade or ignore process. (f) A lawyer should not issue a subpoena to a nonparty fact witness except to compel, for a proper purpose, the witness s appearance at a deposition, hearing, or trial or to obtain necessary documents in the witness s possession. CODE OF PRETRIAL AND TRIAL CONDUCT 9 Ethics and Professionalism for Litigators Bates 141

134 Access to Fact Witnesses and Evidence (a) Subject to the applicable law and ethical principles, and to constitutional requirements in criminal matters, a lawyer may properly interview any person who is not a retained expert, because a fact witness does not belong to any party. A lawyer should avoid any suggestion calculated to induce any witness to suppress evidence or to deviate from the truth. However, without counseling the witness to refrain from cooperating with opposing counsel, a lawyer may advise any witness that he or she does not have a legal duty to submit to an interview or to answer questions propounded by opposing counsel, unless required to do so by judicial or legal process. (b) A lawyer may never suppress any evidence that the lawyer or the client has a legal obligation to reveal or to produce. In the absence of such an obligation, however, it is not a lawyer s duty to disclose any work product, evidence or the identity of any witness. (c) A lawyer must not advise or cause a person to secrete himself or herself or to leave the jurisdiction of a tribunal for the purpose of becoming unavailable as a witness. (d) Except as provided in subparagraphs (1) and (2) below, a lawyer should not pay, offer to pay or acquiesce in the payment of compensation to a fact witness and may never offer or give any witness anything of value contingent upon the content of the witnesses testimony or the outcome of the case. To the extent permitted by the applicable rules of professional responsibility, a lawyer may advance, guarantee or acquiesce in the payment of: (1) expenses reasonably incurred by a witness in attending or testifying; and or testifying; (2) reasonable compensation to a witness for the witness s loss of time in attending (e) A lawyer may solicit witnesses to a particular event or transaction but not to testify to a particular version of the facts. Relations with Consultants and Expert Witnesses (a) In retaining an expert witness, a lawyer should respect the integrity, professional practices and procedures in the expert s field and must never ask or encourage the expert to compromise the integrity of those practices and procedures for purposes of the particular matter for which the expert has been retained. (b) A retained expert should be fairly and promptly compensated for all work on behalf of the client. A lawyer must never make compensation contingent in any way upon the substance of the expert s opinions or written report or upon the outcome of the matter for which the expert has been retained. c) Other than as expressly permitted by governing law, a lawyer should not communicate with, or seek to communicate with, an expert witness concerning the pending litigation whom the lawyer knows to have been retained by another party, unless express permission is granted by counsel for the retaining party. CODE OF PRETRIAL AND TRIAL CONDUCT Medical Liability and Health Care Law March 2013

135 Trial A lawyer must conduct himself or herself in trial so as to promote respect for the court and preserve the right to a fair trial. A lawyer should avoid any conduct that would undermine the fairness and impartiality of the administration of justice, and seek to preserve the dignity, decorum, justness and courtesy of the trial process. Relations with Jurors Lawyers and judges should be respectful of the privacy of jurors during voir dire and after a verdict. A lawyer should abstain from all acts, comments and attitudes calculated to inappropriately curry favor with any juror, such as fawning, flattery, solicitude for the juror s comfort or convenience or the like. Courtroom Decorum (a) Proper decorum in the courtroom is not an empty formality. It is indispensable to the pursuit of justice at trial. (b) In court, a lawyer should always display a courteous, dignified and respectful attitude toward the judge presiding and should promote respect for and confidence in the judicial office. The judge should be courteous and respectful to the lawyer, who is also an officer of the court. (c) A lawyer should never engage in discourteous or acrimonious comments or exchanges with opposing counsel. Objections, requests and observations must be addressed to the court. (d) A lawyer should advise the client and witnesses appearing in the courtroom of the kind of behavior expected and counsel them against engaging in any disrespectful, discourteous or disruptive behavior in the courtroom. Trial Conduct (a) A lawyer has the professional obligation to represent every client courageously, vigorously, diligently and with all the skill and knowledge the lawyer possesses. The conduct of a lawyer before the court and with other lawyers should at all times be characterized by civility. A lawyer should present all proper arguments against rulings the lawyer deems erroneous or prejudicial and ensure that a complete and accurate case record is made. In doing so, the lawyer should not be deterred by any fear of judicial displeasure. (b) In appearing in a professional capacity before a tribunal, a lawyer must not: (1) improperly obstruct another party s access to evidence or unlawfully alter, destroy or conceal a document or other material having potential evidentiary value; nor should a lawyer counsel, permit or assist another person to do any such act; (2) falsify evidence, counsel or assist a witness to testify falsely, or offer an inducement to a witness that is prohibited by law; or (3) allude to any matter that the lawyer does not reasonably believe is relevant or will not be supported by admissible evidence, assert personal knowledge of facts in issue except when CODE OF PRETRIAL AND TRIAL CONDUCT 11 Ethics and Professionalism for Litigators Bates 143

136 testifying as a witness, or state a personal opinion as to the justness of a cause, the credibility of a witness, the culpability of a civil litigant or the guilt or innocence of an accused. (c) A lawyer should not interrupt or interfere with an examination or argument by opposing counsel, except to present a proper objection to the court. (d) When a court has made an evidentiary ruling, a lawyer should not improperly circumvent that ruling, although a lawyer may seek to make a record of the excluded evidence or a review of the ruling. (e) A lawyer must not attempt to introduce evidence or to make any argument that the lawyer knows is improper. If a lawyer has doubt about the propriety or prejudicial effect of any disclosure to the jury, the lawyer should request a ruling out of the jury s hearing. (f) A lawyer should never engage in acrimonious conversations or exchanges with opposing counsel in the presence of the judge or jury. (g) Examination of jurors and of witnesses should be conducted from a suitable distance, except when handling evidence or circumstances otherwise require. (h) Unless local custom dictates otherwise, a lawyer should rise when addressing or being addressed by the judge, except when making brief objections or incidental comments. A lawyer should be attired in a proper and dignified manner in the courtroom. (i) A lawyer should not in argument assert as a fact any matter that is not supported by evidence. (j) A lawyer must never knowingly misquote or mischaracterize the contents of documentary evidence, the testimony of a witness, the statements or argument of opposing counsel, or the language of a judicial decision. (k) A lawyer should not propose a stipulation in the jury s presence unless the lawyer knows or has reason to believe the opposing lawyer will accept it. (l) A lawyer who receives information clearly establishing that the client has, during the representation, perpetrated a fraud on the court should immediately take the actions required by the appropriate procedural and ethical rules. Public Statements about Pending Litigation A case should be tried in the courtroom and not in the media. A lawyer should follow all rules and orders of the court concerning publicity. In the absence of a specific rule or order, a lawyer should not make any extrajudicial statement that may prejudice an adjudicative proceeding. CODE OF PRETRIAL AND TRIAL CONDUCT Medical Liability and Health Care Law March 2013

137 American College of Trial Lawyers MacArthur Boulevard, Suite 610 Irvine, California (Phone) (Fax) Website: Ethics and Professionalism for Litigators Bates 145

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139 State Medical Boards The New Adversary? Prevalent Disciplinary Actions Concerning Allopathic and Osteopathic Physicians Gregory A. Chaires JoAnn M. Guerrero Chaires, Brooderson & Guerrero, P.L. Altamonte Lakeside Park 283 Cranes Roost Blvd., Suite 165 Altamonte Springs, FL (407)

140 Gregory A. Chaires and JoAnn M. Guerrero are principals of Chaires Brooderson & Guerrero PL in Altamonte Springs, Florida. Mr. Chaires is board certified by the Florida bar as a specialist in health law. He counsels physicians, physician groups, and hospitals medical staffs on issues concerning reimbursement, Medicare/Medicaid fraud and abuse investigations, and compliance with state and federal laws. Mr. Chaires is a former Florida assistant attorney general. He has been included in The Best Lawyers in America in health law ( ). Ms. Geurrero is experienced in litigation practice and is licensed by the Florida Agency for Health Care Administration as a Licensed Health Care Risk Manager. She was selected for inclusion in Florida Super Lawyers Rising Star 2009 in the area of health law.

141 State Medical Boards The New Adversary? Prevalent Disciplinary Actions Concerning Allopathic and Osteopathic Physicians Table of Contents I. Prevalent Disciplinary Actions II. Standard of Care III. Recordkeeping IV. Inappropriate Prescribing V. Wrong Site Surgery and the Pause Rule VI. Retained Foreign Body VII. Consequences of Disciplinary Actions A. Licensure by Another State B. Specialty Boards C. Third-Party Payors D. Medicare E. National Practitioner Data Bank VIII. Conclusion State Medical Boards The New Adversary? Prevalent... Chaires and Guerrero 149

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143 State Medical Boards The New Adversary? Prevalent Disciplinary Actions Concerning Allopathic and Osteopathic Physicians It is always interesting to consider trends in medicine, not only as they relate to the advancements made in medical technology, but also as they also pertain to the unfortunate continuing struggles faced by medical professionals. As health care attorneys, we feel it is certainly well advised to have practitioners consider the nature of the actions that frequently give rise to investigations by state licensing agencies. Additionally, we feel it is imperative to consider how such matters are reported to the Federation of State Medical Boards and the impact of such actions on Medicare and other managed care organizations. It is our hope that through this article, a practitioner may glean a better understanding of these more frequently observed investigations, use this information to evaluate one s own practice and perhaps avoid such an investigation or disciplinary action and understand the overall consequences of disciplinary actions. I. Prevalent Disciplinary Actions To address frequently seen issues of risk among the masses of licensees in varied professions, new laws have progressively been implemented. Compounding this effort in the medical field is the increased vigilance of hospitals, ambulatory surgery centers and practitioners who routinely implement enhanced policies and procedures to decrease risk. In no particular order of frequency, the categories below are the prevalent types of disciplinary actions in which we represent allopathic and osteopathic providers. II. Standard of Care One of the most frequently observed violations in our practice is that which concerns the commission of medical malpractice through the provision of substandard care. A multitude of offenses can fall under such category, which is why it is so commonly seen. In some states, closed medical malpractice claims where a settlement was paid must be reported. These cases are then referred to the state licensing agency, at which time an investigation will be initiated and often an allegation of substandard care or medical malpractice will be cited. Furthermore, some states also require that civil complaints for medical malpractice be filed with the state licensing agency, at which time an investigation can be initiated. Examples of complaints falling under substandard care include anything from allegations of misdiagnosis, improper treatment and poor outcomes to even personal disagreements with a practitioner or his or her staff. Many times, the defense of an alleged standard of care violation requires a very fact-specific examination of patient care. For this reason, appropriate and detailed documentation is critical. Whether the matter investigated involves medical care or a mere discussion with a patient concerning payment of a bill, a prescription refill or the like, we implore each practitioner to ensure that they and their staff maintain timely and detailed documentation. III. Recordkeeping We routinely remind our clients that for all practical purposes under this law, if it is not in the record, it did not happen. Failure to maintain appropriate documentation that justifies the course of treatment of a patient is a commonly seen basis for a such investigations. Documentation issues can stem from failing to properly document patient histories, examination results, test results, records of drugs prescribed, State Medical Boards The New Adversary? Prevalent... Chaires and Guerrero 151

144 dispensed or administered and reports of consultations and hospitalizations. It is our routine practice to suggest that any and all licensed professionals review the respective rules of their licensing boards. It is important to note that a recordkeeping violation not only pertains to the absence of information in a patient record but also if such information is illegible or insufficient to support actions taken by the provider. We commonly see violations where a patient claims he or she was not informed of a test result, was not given appropriate informed consent relative to a surgical procedure or was not informed of a medication sideeffect, as well as cases where a test or procedure was delayed or never ordered. When effective recordkeeping is employed, the defense of such allegations is much less challenging as the record will support a given event occurred. We urge practitioners to take the time to create a more detailed medical record, as it not only enhances the continuity of patient care, but also better serves physicians in the event that their care or billing practices are called into question. To facilitate this effort, many practitioners employ Electronic Medical Recordkeeping ( EMR ) systems. When used appropriately, these systems can be quite beneficial. However, where such systems are used lazily or casually, it is not uncommon to see how EMRs may actually decrease the use of beneficial and specific recordkeeping practices and present a significant setback. An overreliance on check boxes and radio buttons can certainly be detrimental, particularly concerning matters where a narrative detail is more appropriate. Practitioners must use their best efforts to ensure appropriate documentation of the informed consent process for any procedure, detailed documentation of test orders, prescription orders and refills and thorough communicative logs concerning any interactions between any member of the office staff and the patient concerning any subject. IV. Inappropriate Prescribing A more recent trend of investigations have concerned issues involving the inappropriate prescribing of medications. For many state legislatures, the issue of inappropriate prescribing of narcotic medications has been made a high priority. When considering this issue of inappropriate prescribing, such typically relates to the dispensing, administering, mixing or preparing of drugs, whether legend or controlled substances, inappropriately or in excessive or inappropriate quantities. We frequently see allegations of improper prescribing of an incorrect medication to a patient as well as the prescribing of perhaps an appropriate and necessary medication in an excessive quantity or dosage. Importantly, the number of pills or dosage prescribed are not the only criteria considered in reviewing these matters. Special attention is also given to the patient s history, including any history of substance abuse, dependency, diversion or doctor shopping. Also considered is whether any objective medical findings exist to support the patient s complaints and thus, the necessity for the medication prescribed. Any practitioner that prescribes narcotics should review the rules set forth by his or her respective state. Due to the mounting issues concerning pill mills, diversion and drug abuse, we strongly encourage each practitioner to be well informed of the newly implemented and forthcoming laws regarding the prescribing of pain medications. It is further important to be vigilant in recordkeeping as it relates to the refill of such medications, as well as in the use of a pain management agreement with each relevant patient. While a pain management agreement may not be legally required in all states, it is critical that where utilized, a practitioner must enforce each provision of the agreement or appropriately document any circumstances which may mitigate such enforcement in the event of a breach by the patient. We have seen many cases where a physician appropriately had a patient enter into a pain management agreement, yet failed to abide by the agreement through non-performance of random urine testing, the provision of early refills or replacement of medications 152 Medical Liability and Health Care Law March 2013

145 lost by a patient, the allowance of obvious violations of the agreement by the patient and so forth. Weak enforcement of the provisions of such an agreement can only have disastrous consequences for the physician. V. Wrong Site Surgery and the Pause Rule For years, states have expressed their concern over the frequency of wrong-site, wrong-procedure and wrong patient procedures. While the definition of wrong site surgery varies from state to state, for the purposes of this article we consider such to be where a practitioner performs or attempts to perform health care services on the wrong patient, a wrong-site procedure, a wrong procedure, or an unauthorized procedure or a procedure that is medically unnecessary or otherwise unrelated to the patient s diagnosis or medical condition. In hopes of decreasing the number of these cases, many states have promulgated what is known as the Pause Rule. The Pause Rule requires that, except in life threatening emergencies requiring immediate resuscitative measures, that once the patient has been prepared for elective surgery/procedure and the team has gathered and immediately prior to the initiation of any procedure, the team will pause. At that point, the physician(s) performing the procedure will then verbally verify confirm the patient s identification, the intended procedure, and the correct surgical procedure site. Surprisingly, we find that the Pause Rule is not performed often and certainly not immediately before a procedure is initiated. We have seen countless investigations concerning a violation of the Pause Rule, such as the implantation of an incorrect diopter lens in a patient s eye, the performance of a nerve block in the incorrect arm or the performance of a colonoscopy on Patient A instead of Patient B. It is also not unusual to see concurrent allegations regarding inappropriate consent and documentation with pause rule violations. Many times a patient and physician may have a conversation prior to a procedure where a patient may, for example, inform his or her physician that instead of having an epidural steroid injection at the planned location, that another location is desired. The physician will then proceed with performing the ESI at the desired location, rather than the planned location which was specified in a consent document previously executed by the patient. An investigation often ensues and its defense will be particularly challenging as there often will be no documentation of the physician s conversation with the patient in the patient s record, nor will there be a revised, preoperative consent document. Frequently, since the physician had just spoken with the patient, there is no time out performed. Thus, an investigation will be initiated with allegations of performance of a wrong-site procedure, inappropriate recordkeeping, and in some states, a violation of the Pause Rule. Informed consent issues also became prominent in such situations. While many states do not require that informed consent be formalized in writing, one would be foolhardy not to have consent for a procedure properly documented. We would be remiss not to mention that the Pause Rule was attempted in the majority of cases we have observed over the past few years. In fact, we frequently see cases where the Pause Rule was employed, but was not performed to completion. This includes situations where the operative team pauses, while the operating surgeon is washing his or her hands or is otherwise unavailable or not present. Additionally, when verifying information such as operative site location, surgical procedure or patient identity, we urge practitioners to be careful of the source of verification. The following are varied examples of errors we have seen where an attempt to follow the Pause Rule has failed: Rather than review the patient s medical record, the OR staff had a mentally incompetent patient verify the surgical procedure and/or operative site and the patient was incorrect. OR staff verified surgical procedure and/or operative site by looking to the executed consent document, which stated the incorrect surgical procedure and/or operative site. State Medical Boards The New Adversary? Prevalent... Chaires and Guerrero 153

146 OR staff performed a full Pause Rule, yet failed to recognize that the patient record used for verification belonged to a different patient. OR staff observed the presence of an orthopedic brace on one extremity and assumed that it was the correct operative site, when in fact, the patient had unilaterally decided to move the brace to the opposite extremity from the surgical site. It is recommended that practitioners take the Pause Rule requirement seriously and avoid being mechanical in its application. It is imperative that the source of verification be accurate. Thus, verify the procedure and operative site through a review of the patient s medical record, including the consent document, as well as in a discussion with the patient or the patient s guardian. Also, perform a time out immediately before the intended surgery or procedure. This will not only benefit a practitioner in avoiding a wrong-site, wrong-procedure or wrong patient procedure, but will also facilitate the prevention of incidents where a patient claims that he or she did not provide informed consent to undergo the procedure. Following a thorough Pause Rule process will ensure that staff members verify the completeness and accuracy of a consent document, which can also potentially avoid a recordkeeping violation. While this process is perceived by many practitioners as a burdensome delay, it is certainly not a waste of time and unfortunately, is a necessity that can only serve to benefit the practitioner and patient. VI. Retained Foreign Body Another somewhat common violation that we see is when a foreign body is left in a patient, such as a sponge, clamp, forceps, surgical needle, or other paraphernalia commonly used in surgical, examination, or other diagnostic procedures. Regrettably, this violation is still frequently observed. While many errors occur due to an unfortunate miscalculation of sponges or instruments by a circulating or operating staff member, it has been our experience that the operating surgeon may also be held responsible. The risks for such errors are of course enhanced in cases with a high volume of blood loss, in cases where circulating and operative staff members have changed shifts intraoperatively and where more than one physician is providing care to a patient at the same time. It is highly recommended that where such actions occur, or when miscalculation is suspected, that intraoperative fluoroscopy or x-ray be employed to look for the presence of a foreign body prior to closure. VII. Consequences of Disciplinary Actions A. Licensure by Another State It is critical that attorneys and practitioners be fully aware of the reporting requirements by other states where a practitioner is licensed. Many states have requirements where if, for example, the X state licensing agency takes disciplinary action against a license, and the practitioner is licensed in the Z state, the practitioner must timely report the action taken by the X state to the Z state. Otherwise, the other state will likely learn of the disciplinary action when such is reported by the disciplining state agency to the Federation of State Medical Boards ( FSMB ). However, the licensee may be additionally charged by notified state for failing to timely report the disciplinary action. Furthermore, attorneys and practitioners must exercise caution in this regard, even if the practitioner believes that he has let another state license lapse or has not renewed. That state may still investigate and take disciplinary action against the licensee. B. Specialty Boards It is further important to be mindful that if disciplinary action is taken by a state licensing board, a specialty board may also investigate the licensee. To that extent, the specialty board will request a timely 154 Medical Liability and Health Care Law March 2013

147 explanation of the events surrounding the disciplinary matter and conduct a peer review of the matter to ensure that the licensee remains eligible for his or her board certification. C. Third-Party Payors Practitioners and even attorneys often fail to appreciate the impact of a disciplinary action against a licensee. Based upon such action, a third party payor may conduct a detailed investigation of the matter. This process can ultimately lead to a hearing, where if the licensee does not prevail, he or she may no longer be authorized to serve as a provider for the related plan. For obvious reasons, this can be quite devastating and bring about a domino effect where other plans may follow. D. Medicare If Medicare receives a complaint, FMQAI may commence an inquiry into the care a practitioner provided. While FMQAI does not have the authority to take formal action against a practitioner, the findings of such process may be referred on to CMS, who may then take action. Such action may include disqualification of provider status. It is also imperative to recognize that CMS has also listed certain events (wrong site/wrong patient/ wrong procedure, retained foreign bodies, nosocomial infections, etc.) on their list of Never Events. In so doing, CMS has essentially determined that such events should never occur and thus, will never pay to remedy such events. Additionally, any provider found to have committed health care fraud will now be disqualified as a provider for a government-sponsored program. E. National Practitioner Data Bank The National Practitioner Data Bank ( NPDB ) is a reporting agency that was established by Congress with the intention of restricting the ability of incompetent physicians to move from state to state without discovery or disclosure. Disciplinary actions taken by state licensing boards that are based upon professional competence or conduct must be reported to the NPDB within thirty (30) days from the date the adverse licensure action was taken. VIII. Conclusion Much can be gleaned from reviewing the nature of the actions giving rise to investigations by state licensing agencies. While it is well appreciated that a practitioner s time with a patient is limited, the absence of appropriate and timely recordkeeping is certainly deleterious across the board. Consider each of the above disciplinary actions and recognize that to vigorously defend each, appropriate and detailed documentation is imperative. Given the national crisis involving the abuse of pain medications, it is critical that practitioners be vigilant in obtaining a thorough patient history to justify the use of such medications, appropriately apply and enforce pain management agreements, utilize drug screenings when such is warranted and documenting the timely provision of medication refills. Moreover, the incomplete performance of the Pause Rule in fact enhances the likelihood of error, as it provides an incorrect false sense of security. Again, solid detailed documentation is beneficial, both to the patient to facilitate continuity of care, and to the practitioner in the event that such care is called into question. Finally, it is essential to consider the significant ramifications and consequences which may ensue following disciplinary action. The defense of the practitioner certainly does not end upon conclusion of the disciplinary action by the state licensing agency. State Medical Boards The New Adversary? Prevalent... Chaires and Guerrero 155

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149 Characteristics of Physicians Referred for a Competence Assessment: A Comparison of State Medical Board and Hospital Referred Physicians Elizabeth J. Korinek, MPH Center for Personalized Education for Physicians 7351 Lowry Boulevard, Suite 100 Denver, CO (303) (303) [fax]

150 Elizabeth J. Korinek, MPH, has served has the Executive Director of CPEP, the Center for Personalized Education for Physicians, in Denver, Colorado, for more than 15 years. Under her leadership, the program gained national recognition as one of the premier physician competence assessment and education programs in the U.S. Ms. Korinek has overseen the competence assessments of more than 1000 physicians. She collaborates with medical education professionals and leaders of hospitals and medical boards both nationally and internationally. She currently serves on the Board of Directors of the Coalition for Physician Enhancement and on the Competency Assessment Projects Task Force of the National Board of Osteopathic Medical Examiners.

151 Characteristics of Physicians Referred for a Competence Assessment: A Comparison of State Medical Board and Hospital Referred Physicians Table of Contents Presentation Characteristics of Physicians Referred for a Competence Assessment Korinek 159

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153 Presentation Characteristics of Physicians Referred for a Competence Assessment: A Comparison of State Medical Board and Hospital Referred Physicians Elizabeth S. Grace, M.D. Medical Director, CPEP, and Assistant Clinical Professor, Department of Family Medicine, University of Colorado School of Medicine Elizabeth J. Korinek, M.P.H. Executive Director, CPEP Zung V. Tran, Ph.D. Research Professor of Biostatistics and Informatics, University of Colorado, Anschutz Medical Campus ABSTRACT: This study compares key characteristics and performance of physicians referred to a clinical competence assessment and education program by state medical boards (boards) and hospitals. Physicians referred by boards (400) and by hospitals (102) completed a CPEP clinical competence assessment between July 2002 and June Key characteristics, self-reported specialty, and average performance rating for each group are reported and compared. Results show that, compared with hospital-referred physicians, board-referred physicians were more likely to be male (75.5% versus 88.3%), older (average age 54.1 versus 50.3 years), and less likely to be currently specialty board certified (80.4% versus 61.8%). On a scale of 1 (best) to 4 (worst), average performance was 2.62 for board referrals and 2.36 for hospital referrals. There were no significant differences between board and hospital referrals in the percentage of physicians who graduated from U.S. and Canadian medical schools. The most common specialties referred differed for boards and hospitals. Conclusion: Characteristics of physicians referred to a clinical competence program by boards and hospitals differ in important respects. The authors consider the potential reasons for these differences and whether boards and hospitals are dealing with different subsets of physicians with different types of performance problems. Further study is warranted. Keywords: clinical competence, competence assessment, state medical licensing board, physician performance Introduction Competence assessment and remedial education programs are important tools for state medical boards (boards) and hospitals. CPEP, the Center for Personalized Education for Physicians, offers such programs. CPEP was founded as an independent notfor-profit organization in 1990 through the collaboration of several Colorado healthcare organizations, including the Colorado Foundation for Medical Care, COPIC Insurance Company, Colorado Hospital Association, Colorado Medical Society, University of Colorado School of Medicine, Colorado Society of Osteopathic Medicine and others. CPEP s founders were responding to a recognized need to remediate underperforming physicians 1 and were inspired by the 1989 Planning Conference on Focused/Prescribed/Remedial Medical Education for Enhanced Clinical Competence. 2 Though it was originally envisioned as a resource for Colorado, CPEP quickly became a national center, receiving its first out-of-state referral in Boards have referred physicians to the program since its inception, with the first Colorado Board of Medical Examiners (now the Colorado Medical Board) referral in March 1991, and other boards referring soon thereafter. In 2009, CPEP completed its 1,000th competence assessment, and in 2010 celebrated its 20th anniversary. Only limited information has been published about physicians who have presented for competence assessment. A recent survey provides information about both U.S. and international assessment programs. 3 Several programs in Canadian provinces have described their programs and experiences. 4,5,6,7,8,9 In the United Kingdom, the National Clinical Assessment Service (NCAS) published a comprehensive overview of its first four years of operation. 10 However, significant differences in the structure and operation of medical practice, medical regulation and physician assessment in Canada and the United Kingdom make it problematic Characteristics of Physicians Referred for a Competence Assessment Korinek JOURNAL of MEDICAL REGULATION VOL 96, N O 3 JournalMedReg_Vol96_3 final.indd 8 2/7/11 3:41 PM

154 to attempt to generalize and compare the experience and processes of those countries to the U.S. Previous papers about CPEP have described the program and its development 1 or have discussed limited characteristics of participants. 11 Cerda et al described the University of Florida Comprehensive Assessment and Remedial Education Services (CARES) program and provided the specialties of 30 physicians who completed that program in its first two years. 12 The most comprehensive information published about any U.S. program has been from the University of California, San Diego, Physician Assessment and Clinical Education (PACE) program. 13 By 2009, that program had evaluated close to 900 physicians; in the article the authors discussed their process for physician assessment and described a cohort of 298 physicians assessed between 2002 and The experience of the CPEP program adds substantively to the information currently available about physicians referred to a competence assessment center. A total of 588 physicians participated in a CPEP competence assessment between 2002 and Of this total, 502 were referred to CPEP by boards (n=400) and by hospitals (n=102). An additional 86 physicians were referred by other types of organizations or indicated that they were self-referred. In this paper, the focus is on the comparison of key characteristics of and assessment performance between board- and hospitalreferred physicians. Based on CPEP s experience and knowledge of the circumstances surrounding the referral of these physicians, the authors hypothesized that physicians who are referred by boards might differ in important ways from those referred by hospitals. Methods Participant selection The participants in this study included all physicians (M.D. or D.O.) who were referred for assessment by a board or hospital and who completed a CPEP assessment between July 2002 and June Some of the 502 physicians included in this study were referred for and completed more than one assessment during this time; 13 physicians presented twice for competence assessments, and one presented three times during this eight-year period. Repeat enrollees were sometimes referred by different parties and generally were referred for different incidents or concerns; typically the enrollments were separated by a period of several years. Since some of the characteristics evaluated in this study would generally not change (gender, country of training, specialty), the authors decided that each participant should only be represented once in the calculations. Therefore, the data from the most recent assessment were included for those physicians who enrolled in the assessment process more than once. Data on reentry physicians (physicians returning to practice after a voluntary break from practice) were not included because the authors believe that the characteristics of reentry physicians may differ significantly from physicians referred for competence assessment. Assessment process Typically, physicians have enrolled in the CPEP assessment program for a clinical competence evaluation after the physician s skills or abilities have been questioned by a board or hospital. The evaluation is often part of a disciplinary agreement or part of an investigation. The assessment consists of an evaluation of competence in the physician s current, previous or prospective practice. At the time of enrollment, the 502 participants included in this study completed a self-report form to provide demographic information such as gender and age, location (country) of medical school, specialty, years of post-graduate training and other information about their professional status; if information in this form was unclear or missing, CPEP staff clarified the information through discussion with the participant. The participants completed an assessment that included 90-minute interviews with specialty-matched board-certified physician consultants who also reviewed charts from the physician s current or previous practice, if available. Depending on the scope of the assessment and areas of practice/ specialty(ies) to be covered, two to four interviews were conducted. Participants also completed simulated patient encounters two encounters for psychiatry or three for all other specialties that involve patient contact. The assessment also included a documentation exercise, a cognitive function screen and, depending on the physician specialty, written testing. CPEP staff assigned an overall rating of the participant s performance on the assessment. Factors considered in determining the performance ratings were the extent and characteristics of educational needs identified and the level of supervision required to ensure patient safety while the physician addressed the educational needs. Two CPEP physician reviewers and the Executive Director reviewed the data for each participant and reached agreement regarding the factors and level of educational needs. 162 Medical Liability and Health Care Law March 2013 JOURNAL of MEDICAL REGULATION VOL 96, N O 3 9 JournalMedReg_Vol96_3 final.indd 9 2/7/11 3:41 PM

155 Physicians who demonstrated no to minimal educational needs were assigned a performance rating of 1; physicians with global educational deficits were rated a 4. Physicians rated 2 and 3 demonstrated moderate to extensive educational needs, with the latter having more extensive educational needs warranting a recommendation for more intensive education, such as initial practice in a supervised setting with gradually increasing independence. Data calculated and presented Characteristics and assessment performance of the physicians referred by boards and hospitals who completed assessments at CPEP from July 2002 through June 2010 are reported. The characteristics reported are gender, average age, degree (M.D., D.O.), location of medical school (U.S. and Canadian LCME-approved schools, international medical schools), specialty and proportion with current board certification by an American Board of Medical Specialties (ABMS) or American Osteopathic Association (AOA) Bureau of Osteopathic Specialists. The average performance rating on the assessment for each group was reported. Statistical analyses Prior to any analyses, data were checked for possible outliers and inconsistencies in the data fields. As needed, queries were generated and resolved. Initial analyses consisted of calculating descriptive statistics for continuous variables and frequency distributions for categorical variables. Variables with highly skewed distributions were considered for log transformations; none of the variables analyzed fell into this category. FACTORS CONSIDERED IN DETERMINING THE PERFORMANCE RATINGS WERE THE EXTENT AND CHARACTERISTICS OF EDUCATIONAL NEEDS IDENTIFIED AND THE LEVEL OF SUPERVISION REQUIRED TO ENSURE PATIENT SAFETY WHILE THE PHYSICIAN ADDRESSED THE EDUCATIONAL NEEDS. A combination of nonparametric (chi-square) and parametric (t-test, one-way ANOVA) methods were used to test associations and compare means. 14 When more than two means were compared, a post-hoc test (Tukey method) was used for multiple comparison purposes. 14 Statistical tests were two-tail with significance set at the p<0.05 level. SPSS Statistics 18 (SPSS Inc., Chicago, IL) was used for all analyses and data management tasks. Results Referral sources for all 588 physicians who presented for competence assessments between July 2002 and June 2010 are listed in Table 1. The most common referral source for physicians enrolled in the CPEP assessment program was boards, responsible for 68% (400) of referrals. Hospitals were the next most common referral source, providing 17.3% (102) of CPEP referrals. The remaining 86 physicians were referred from other types of medical organizations and attorneys, or reported that they were self-referred. Table 1 Source of referral CPEP participants July 2002 through June 2010 Referral source Number (n) State medical or osteopathic board 400 Hospital 102 Self 26 Other 24 Attorney 13 Medical clinic 12 Physician health program 8 Disability insurance carrier 3 Total 588 Of the board-referred group, 89% (356) completed their degree at an allopathic medical school while 11% (44) completed osteopathic training; for the hospital-referred group, type of degree was 88.2% (90) allopathic versus 11.8% (12) osteopathic. Table 2 presents key characteristics of the participants including gender, average age, medical school (U.S./Canadian schools compared to other international schools), specialty board certification status (for boards approved by the ABMS or AOA Bureau of Osteopathic Specialists) and average performance of the board and hospital groups. The five most common specialties represented in each group are presented in Table 3. Comparison of physicians referred by boards versus hospitals Gender, average age at the time of assessment, medical school (international medical school graduate status), specialty board certification status, and performance rating for board-referred physicians and hospital-referred physicians were compared 10 JOURNAL of MEDICAL REGULATION VOL 96, N O 3 Characteristics of Physicians Referred for a Competence Assessment Korinek 163 JournalMedReg_Vol96_3 final.indd 10 2/7/11 3:41 PM

156 (see Table 2). Statistical analysis shows significant differences between the two groups regarding the gender, specialty board certification status and average age at the time of the assessment. Board referrals were more likely to be male (p<0.001), and older (p<0.001) than their hospitalreferred peers. Board referrals were less likely to be specialty board certified (p<0.001). To explore whether the age difference between board and hospital referrals might be responsible for this finding, comparison of the average age at the time of the assessment and specialty board certification status was made. There was no statistically significant difference in the average age at the time of the assessment of those specialty board certified (52.74 years) and those who were never board certified (52.66 years) (p=0.99). There was no statistically significant difference between board- and hospital-referred physicians in the proportion of physicians who were international medical school graduates. The mean performance rating for board referrals was 2.62, which was slightly worse than that of hospital referrals, whose ratings averaged 2.36 (p=0.007). Discussion These data identify significant differences in the characteristics of physicians referred by boards and those referred by hospitals. In the discussion of these findings, we present factors in the hospital setting that could contribute to the differences noted. While the board-referred group also includes physicians who practice in the hospital setting, we believe that the relative pertinence of these factors is greater for the hospital-referred physician group. Gender A majority (88.3%) of the physicians referred by boards were male. The proportion of male physicians who were referred by boards appears disproportionate to the general physician population, based on American Medical Association (AMA) Physician Masterfile data that indicate that 71.6% of physicians in the U.S. were male in CPEP enrollments Table 2 Characteristics of physicians referred by state boards and those referred by hospitals Board-referred physicians Hospital-referred physicians p value Total number (percentage) 400 (68.0%) 102 (17.3%) Male gender 353 (88.3%) 77 (75.5%) p<0.001 Average age, years p<0.001 Medical school US, Canada International 319 (79.8%) 81 (20.3%) 85 (83.3%) 17 (16.7%) p=0.415 (NSS) Currently board certified 247 (61.8%) 82 (80.4%) p<0.001 Assessment performance p=0.007 rating (mean) Table 3 Most frequent specialties of physicians referred by boards and by hospitals Ranking Board-referred physicians Hospital-referred physicians Specialty Number (percentage) Specialty Number (percentage) 1 FM 102 (25.5%) OBG 31 (30.4%) 2 IM 62 (15.5%) FM 18 (17.6%) 3 GP 35 (8.8%) GS 13 (12.7%) 4 GS 31 (7.8%) IM 8 (7.8%) 5 P 24 (6%) ANE 6 (5.9%) FM=family medicine, IM=internal medicine, GP=general practice, GS=general surgery, P=pediatrics, OBG=obstetrics and gynecology, ANE=anesthesiology 164 Medical Liability and Health Care Law March 2013 JOURNAL of MEDICAL REGULATION VOL 96, N O 3 11 JournalMedReg_Vol96_3 final.indd 11 2/7/11 3:41 PM

157 over time have reflected an overall disproportionate preponderance of males. A male preponderance in board referrals to the CPEP program is consistent with data previously published about U.S. physicians referred for competence assessments. 13 Male gender was also more common in NCAS referrals (U.K). than would be expected, and this did not appear to be related to gender-specific choices in practice specialty. 10,16 Data on U.S. licensure board discipline also show a disproportionate representation of males. 17,18,19,20 The reasons for males being overrepresented in these settings are not readily apparent, but may involve legitimate differences in performance between genders or other unrelated factors. Firth-Cozens proposed some potential reasons for THESE DATA IDENTIFY SIGNIFICANT DIFFERENCES IN THE CHARACTERISTICS OF PHYSICIANS REFERRED BY BOARDS AND THOSE REFERRED BY HOSPITALS. the male preponderance in the NCAS data, including different communication skills of women and men and greater leniency of supervisors for women. Thus, though the reasons are unknown, the gender distribution for board referrals is not surprising. The proportion of males referred by hospitals (75.5%) more closely approximates the proportion of males in the physician population at large, again based on the AMA Masterfile data. As we consider the reason why males seem to be overrepresented in board referrals, an equally compelling question is why this referral pattern does not hold true for hospitals. A study of hospitalists showed that 74% of hospitalists (defined in this reference as a physician who works at least 50% of the time in the hospital setting) that responded to a survey were male, 21 making it unlikely that the demographics of the hospital physician are responsible for a difference in this study between hospital referrals and board referrals (which would include inpatient and outpatient physicians). The factors that Firth-Cozens considers as potentially responsible for a disproportionate number of males referred to NCAS (communication skills, leniency toward women), 16 if present, would seem to be relevant in the hospital setting. We cannot definitively answer the question of why there is a higher rate of referral of males by boards compared with hospitals. The events that lead to questions about a physician s clinical competence are complicated and multifaceted; thus, so are the reasons for referral for clinical competence evaluations. It may be that boards and hospitals refer physicians for very different reasons, and that these differences lead to different gender proportions. Age Physicians referred by boards were older (54.1 years) than hospital-referred physicians (50.3 years) (statistically significant, p<0.001). Again, though interesting to note, the reasons this might be true can only be hypothesized. Though the characteristics of hospitalists do not necessarily represent the overall characteristics of physicians who work in the hospital setting, the reported average age of hospitalists is fairly young at 40 years, 21 possibly contributing to a younger average age of the hospital-referred physician. CPEP envisions physician dyscompetence and incompetence as developing gradually over time (see Figure 1), and there are some data to support that increasing age is associated with decreased performance 5,9,22,23 and with increased risk of board discipline. 19 Hospitals are local resources proximate in both time and location to a physician s practice. It is logical and appropriate that local resources might identify concerns about physician competence earlier (when the physician is younger). Practice specialty Primary care specialties, specifically family medicine and internal medicine, are common self-reported specialties of physicians referred for CPEP assessments, and they are among the top five specialties for both board-referred and Figure 1 Time line representing physician competence Competence Dyscompetence Incompetence Time/Age 12 JOURNAL of MEDICAL REGULATION VOL 96, N O 3 Characteristics of Physicians Referred for a Competence Assessment Korinek 165 JournalMedReg_Vol96_3 final.indd 12 2/7/11 3:41 PM

158 hospital-referred physicians. Other assessment programs have also reported a preponderance of primary care physicians. 12,13 CPEP data regarding specialty distribution of referred physicians should be a relatively accurate reflection of the actual referral patterns because CPEP accepts physicians into its assessment program from all specialties. However, CPEP has encountered misunderstanding by some referring organizations that assessment programs can only evaluate physicians in primary care; such organizations may not be referring physicians of all specialties to assessment programs, potentially resulting in an underrepresentation of some specialties. The differences in types of specialists referred by hospitals and boards are particularly interesting, with obstetrics and gynecology ranking sixth for boards but first for hospitals, and anesthesiology ranking ninth for boards and fifth for hospitals. THE EVENTS THAT LEAD TO QUESTIONS ABOUT A PHYSICIAN S CLINICAL COMPETENCE ARE COMPLICATED AND MULTIFACETED AND, THUS, SO ARE THE REASONS FOR REFERRAL FOR CLINICAL COMPETENCE EVALUATIONS. Possible explanations for this may include types of patients cared for by these two specialties, the impact of hospital peer review processes and the medico-legal risks for the hospital related to labor and delivery and to surgical patients. Specialty board certification Current specialty board certification was more common among hospital-referred physicians (80.4%) than board-referred physicians (61.8%), and this difference reached statistical significance (p<0.001). CPEP determined through statistical analysis that age difference between board and hospital referrals was not likely to be responsible for this observation. The difference in specialty board certification status is logical given the general trends towards board certification as a requirement for hospital privileges, though these requirements are far from universal. 24,25 Another possible contributor to this observation could be the requirements for certification established by specialty boards. Some specialty boards require that the physician hold a full and unrestricted license to maintain certification. Some (but not all) of the board-referred physicians would have already been subject to a board order, and therefore not eligible to maintain certification. For those physicians who reported they were not currently certified, there may be different implications for those who lost certification on the basis of their license status alone compared with those who never certified or those who allowed certification to lapse. Performance Hospital-referred physicians performed slightly better on the CPEP assessment than board-referred physicians, and this difference is statistically significant. While it is not possible to explain the basis for this with certainty, the authors propose some reasons that the performance of boardreferred physicians would be worse than their hospital-referred peers. To a large degree, this consideration echoes the factors discussed above regarding physician age: hospitals, as a local resource, may have the opportunity to identify concerns sooner, earlier on the line of progression from competence through dyscompetence to incompetence. Routine peer review processes might identify problems at an earlier stage. In the typical progression of reporting, problematic behavior or results that occur at a hospital may be reported to and evaluated by the hospital, and this can be a prolonged process. When these processes do not resolve the issue or when the issues are of great enough concern initially, the concern may be passed along to the board. This could result in more egregious cases being presented to the board. In addition, if a hospital becomes aware of but does not address a concern about a physician s care, the problem may progress and may then ultimately be reported to the board after significant time has passed and after further decline has occurred. Furthermore, the significant medico-legal risks faced by hospitals may prompt hospitals to address questions about a physician s quality of care at an earlier stage. Lastly, the observation that hospital-referred physicians were statistically more likely to have current specialty board certification may be a factor in the better relative performance of the hospital-referred physician. Limitations Many of the data elements used for this study were based on self-reported information. Though CPEP staff made every effort to clarify ambiguous or inconsistent responses, either through questioning the physician participant at the time of assessment or through review of relevant documents during the assessment process or during the preparation of 166 Medical Liability and Health Care Law March 2013 JOURNAL of MEDICAL REGULATION VOL 96, N O 3 13 JournalMedReg_Vol96_3 final.indd 13 2/7/11 3:41 PM

159 this study, inaccuracies in self-reported data are not uncommon. The potential exists for confusion about one s own specialty board certification status, as an unencumbered and active license is typically a requirement to maintain specialty board certification, and CPEP is aware of at least some participants who had been subject to a board action against their licenses but were not aware that their specialty board certification had been lost as a result. Concluding Thoughts Clinical competence assessment programs are useful tools for boards and hospitals in their quest to address questions about quality of care and patient safety. The data in this study highlight differences in characteristics of physicians referred from these two types of organizations. It is possible that the different demographic data of the two groups indicate that physicians in very different circumstances come to the attention of a board versus a hospital, demonstrating the complementary and overlapping nature of these two entities in the safety net of self-regulation of the medical profession. In some cases, the findings herein may reflect that hospitals have the opportunity to intervene at an earlier phase in a IDENTIFICATION OF PATTERNS FOR REFERRAL THAT ARE RELATED TO OR FOUND TO BE BASED ON ACTUAL DIFFERENCES IN COMPETENCE COULD PROVIDE ADDITIONAL OPPORTUNITIES FOR EARLY, PROACTIVE INTERVENTION PRIOR TO AN ADVERSE EVENT OR COMPLAINT. physician s decline from competence to incompetence. Currently in the U.S., board investigations into competency and discipline are largely complaint-driven. 26 Hospitals also rely on complaint- or critical incident-driven investigation, though there is some degree of proactive screening for qualityof-care concerns in the hospital setting that might raise concerns about a physician s competence at an earlier stage. Identification of patterns for referral that are related to or found to be based on actual differences in competence could provide additional opportunities for early, proactive intervention prior to an adverse event or complaint. Earlier intervention represents an opportunity for the physician to remediate his or her deficits when educational needs are more contained in scope, and remediation can be accomplished more quickly, cost effectively and safely. Short of employing routine random screenings for quality-of-care concerns, as is done in some Canadian provinces, 5,6,7,8 understanding risk factors for referral to competence assessment programs and risk factors for poorer performance will help the medical profession move toward preventive strategies for the benefit of patients as well as the physician involved. These data answer some questions about who gets referred for a competence assessment, and raise many exciting points for future research about risk factors for referral to a competence assessment program as well as risk factors for declining performance and clinical dyscompetence. References 1. Bunnell KP, Kahn KA, Kasunic LB, Radcliff S. CPEPP: development of a model for personalized continuing medical education. J Contin Educ Health Prof. 1991;11(1): Pierson RD, editor. Summary, Focused/Prescribed/Remedial Medical Education for Enhanced Clinical Competence A Planning Conference; 1989 Jan 28-29; San Francisco. 3. Humphrey C. Assessment and remediation for physicians with suspected performance problems: an international survey. J Contin Educ Health Prof. 2010;30(1): McCauley RC, Paul WM, Morrison GH, Beckett RF, Goldsmith CH. Five-year results of the peer assessment program of the College of Physicians and Surgeons of Ontario. CMAJ 1990;143(11): Norman GR, Davis DA, Lamb S, Hanna E, Caulford P, Kaigas T. Competency assessment of primary care physicians as part of a peer review program. JAMA. 1993;270: Page GG, Bates J, Dyer SM, Vincent DR, Bordage V, Jacques A, Sindon A, Kaigas T, Norman GR, Kopelow M, Moran J. Physician assessment and physician enhancement programs in Canada. CMAJ. 1995;153(12): Hall W, Violato C, Lewkonia R, Lockyer J, Fidler H, Toews J, Jennett P, Dondoff M, Moores D. Assessment of physician performance in Alberta: the physician achievement review. CMAJ 1999;161: Goulet F, Jacques A, Gagnon R. An innovative approach to continuing medical education Acad Med. 2005;80: Goulet F, Gagnon R, Gingras ME. Influence of remedial professional development programs for poorly performing physicians. J Contin Educ Health Prof. 2007;27(1) : National Clinical Assessment Service. National Clinical Assessment Service Analysis of the first four years referral data. July National Clinical Assessment Service, London. 11. Korinek LL, Thompson LL, McRae C, Korinek E. Do physicians referred for competency evaluations have underlying cognitive problems? Acad Med. 2009;84(8): Cerda JJ, Van Susteren TJ, Hatch R, Herkov M. Remedial education: Can this doctor be saved? Transactions of the Clinical and Climatological Association 2000; 1(1): JOURNAL of MEDICAL REGULATION VOL 96, N O 3 Characteristics of Physicians Referred for a Competence Assessment Korinek 167 JournalMedReg_Vol96_3 final.indd 14 2/7/11 3:41 PM

160 13. Norcross WA, Henzel TA, Freemen K, Milner-Mares J, Hawkins RE. Toward meeting the challenge of physician competence assessment: the University of California, San Diego Physician Assessment and Clinical Education (PACE) program. Acad Med 2009;84(8): Rosner B. Fundamentals of Biostatistics. 6th ed. CA: Thompson Brooks/Cole; American Medical Association. Physician Characteristics and Distribution in the U.S. Chicago: American Medical Association; Firth-Cozens J. Doctors with difficulties; why so few women? Postgrad Med J. 2008; 84: Morrison J, Wickersham P. Physicians disciplined by a state medical board. JAMA. 1998;279(23): Clay SW, Conaster RR. Characteristics of physicians disciplined by the State Medical Board of Ohio. JAOA. 2003;103(2): Kohatsu ND, Gould D, Ross LK, Fox PJ. Characteristics associated with physician discipline: a case-control study. Arch Intern Med. 2004;164: Khaliq AA, Dimassi H, Huang CY, Narine L, Smego RA. Disciplinary action against physicians: who is likely to get disciplined? Amer Jour Med. 2005;118: Hoff TH, Whitcomb WF, Williams K, Nelson JR, Cheesman RA. Characteristics and work experiences of hospitalists in the United States. Arch Intern Med. 2001;161: Choudhry NK, Fletcher RH, Soumeral SB. Systematic review: the relationship between clinical experience and quality of health care. Ann Intern Med. 2005;142: LoboPrabhu SM, Molinari VA, Hamilton JD, Lomax JW. The aging physician with cognitive impairment: approaches to oversight, prevention, and remediation. Am J Geriatr Psychiatry. 2009;17(6): Freed GL, Dunham KM, Singer D. Use of board certification and recertification in hospital privileging: policies for general surgeons, surgical specialists, and nonsurgical subspecialists. Arch Surg. 2009;144(8): Freed GL, Uren RL, Hudson EJ, Lakhani I, Wheeler JR, Stockman JA 3rd. Policies and practices related to the role of board certification and recertification of pediatricians in hospital privileging. JAMA. 2006; 295(8): Federation of State Medical Boards. The Special Committee on Evaluation of Quality of Care and Maintenance of Competence. Approved May 1998; revised policy adopted by House of Delegates April Medical Liability and Health Care Law March 2013 JOURNAL of MEDICAL REGULATION VOL 96, N O 3 15 JournalMedReg_Vol96_3 final.indd 15 2/7/11 3:41 PM

161 Anatomy of the Spine: Back Surgery and Its Risks Samuel D. Hodge, Jr. Temple University 464 Alter Hall Philadelphia, PA (215)

162 Samuel D. Hodge, Jr., a skilled litigator, is a professor and chair of the Legal Studies Department of Temple University where he teaches both law and anatomy. Professor Hodge is a graduate of Temple University s Beasley School of Law and the Graduate Division of the Law School. He has authored more than 100 articles on medical/legal topics and has written five books. His Anatomy of Litigators text was selected as the outstanding legal publication in 2007 and his most recent book, ABA Medical-Legal Guides: Clinical Anatomy for Lawyers was published by the American Bar Association in December of Professor Hodge lectures nationally on the intersection of law and medicine and is considered one of the most popular CLE speakers in the country.

163 Anatomy of the Spine: Back Surgery and Its Risks Table of Contents I. An Overview II. Introduction III. The Anatomy of the Spine A. Vertebrae B. Intervertebral Disks C. Spinal Nerves IV. Spinal Conditions A. Spinal Stenosis B. Spondylosis vs. Spondylolisthesis C. Herniated Disc V. Spinal Surgeries A. Laminectomy and Laminotomy B. Discectomy C. Spinal Fusion D. Corpectomy and Strut Graft E. Foraminotomy VI. Common Complications from Back Surgery VII. Conclusion Anatomy of the Spine: Back Surgery and Its Risks Hodge 171

164

165 Anatomy of the Spine: Back Surgery and Its Risks I. An Overview More than one half million Americans have back surgery each year. For some, the procedure is perceived as unsuccessful, leaving the patient in more pain or addicted to medication. This presentation will examine the most common forms of back surgery from spinal fusions to percutaneous laser discectomies. Each procedure will be explained and will be followed by a discussion of the complications from each technique. II. Introduction Surgical and diagnostic advances during the past two decades have caused a significant increase in spinal operations. However, the short and long term complications resulting from these procedures can limit the benefits. Risk Factors for Complications After Spine Surgery Identified in New Study, Science News, September 26, The average age of the surgical candidate is 55.5 years old, fifty-four percent of the patients are men and seventy-six percent are Caucasian. These individuals underwent surgery for such problems as disc herniations, spinal stenosis and degenerative disc disease. Id. Statistically, 16.4 percent of these people develop surgical complications with more problems occurring in the lumbar region than the cervical spine. Life-threatening complications increase with surgical complexity from 2.3 percent for simple decompressions to 5.6 percent for those with complex fusions. Id. III. The Anatomy of the Spine The spine is made up of a variety of structures including the vertebrae, intervertebral discs, nerves, spinal cord and soft tissues. The following is an outline of these structures: A. Vertebrae The spine extends from the base of the skull to the pelvis and consists of a number of vertebrae. These bones are stacked upon each other, with each separated from the bones above and below by soft cushion-like pads, known as intervertebral discs. Hodge and Hubbard, ABA Medical-Legal Guides: Clinical Anatomy for Lawyers, The Anatomy of the Spine, Chapter 7, American Bar Association, For the most part, vertebrae have two major aspects the body and the arch. The body is the large circular portion in the front which carries the weight of the spine and is separated from each of the vertebrae above and below by an intervertebral disc. The back portion of the bone, the vertebral arch, is more delicate and designed to allow for movement by forming pairs of synovial joints, or the moveable points of contact, with the vertebrae above and below it. Id. The vertebral body and arch enclose a roughly oval-shaped space known as the foramen. When the vertebrae are stacked upon each other, these individual openings form a long hollow tube, much like what happens when napkin rings are staked upon each other, called the vertebral canal. The spinal cord runs through these openings. Id. Anatomy of the Spine: Back Surgery and Its Risks Hodge 173

166 B. Intervertebral Disks The intervertebral disks are pillow-like cushions that act as shock absorbers and allow the back to move, bend and twist. Keith Bridwell, Intervertebral Discs, com/anatomy/intervertebral-discs (Last visited February 25, 2012). These cushions also allow the vertebrae to slide against one another, providing for a small degree of mobility. Each disc is made up of two parts, a soft gel-like center called the nucleus pulpous and a tough outer edge, or annulus fibrous, consisting of an outer edge made up of a number of fibrous concentric rings. Id. C. Spinal Nerves Spinal nerves or nerve roots extend from the spinal cord and exit through the hole in the vertebrae known as the foramen. These peripheral nerves transmit information from the spinal cord to the rest of the body, and signals return to the spinal cord for transmission to the brain. Spinal Cord Anatomy, Apparelyzed, (Last visited February 24, 2012). The spinal cord ends at an area dubbed the conus medullaris and this happens to be around the lumbar nerves L1 and L2 in the average adult. Following the termination of the spinal cord, the nerves continue down the back as a bundle called the cauda equine or horse s tail. Id. These nerves transmit signals to and from the lower limbs and pelvic organs. Cauda Equina, Medline Plus, htm (Last visited February 24, 2012). Anatomically, each of these nerves contains sensory and motor nerve roots. Sensory nerves relay information such as pain, temperature and touch from the body upward toward the spinal cord on its way to the brain. On the other hand, motor nerves carry signals from the spinal cord to the muscles of the legs, causing the muscles to contract and the body to move. Peter Ullrich, Spinal Cord and Spinal Nerve Roots, Spine- Health, conditions/spine-anatomy/spinal-cord-and-spinal-nerve-roots (Last visited February 24, 2012). Each sensory nerve controls sensation in a specific patch of skin known as a dermatome. Hodge, Anatomy for Litigators, supra., at 101. These predictable patterns are named based upon the spinal nerves which supply them. Myotomes and Dermatomes, Apparelyzed, apparelyzed.com/myo-dermatomes. html (Last visited February 24, 2012). By knowing the sensory pattern that the nerve root follows, a physician can ascertain which nerve root is affected, thereby identifying which level of the spine is involved. Cheng, Direct Examination of the Plaintiff s Medical Expert, ATLA Winter Convention Reference Materials Advocacy Track: The Trial of Damages in a Muscle Sprain Case, Winter 2001, ATLA-CLE 113 (2001). For instance, discomfort going down the leg to the small toe in the general pattern of the S1 dermatome provides evidence that a herniated disk may be pinching the S1 nerve root. Frank Netter, Atlas of Human Anatomy, Disks, Spurs, Stenosis: Slippage, and Osteoporosis, Chapter 6, Icon Learning Systems/Elsevier. If the motor nerve is also implicated, the person will develop weakness in particular muscles supplied by that nerve root. This is known as a myotome and refers to a set of muscles supplied by an individual nerve root. Samuel Hodge and Jack Hubbard, Show me the Pain Pitfalls and Limitations of Diagnostic Imaging of the Low Back, Journal of Medicine and Law, Volume XIV, Issue 1 pages 129 to 159. IV. Spinal Conditions The spine is susceptible to a host of medical problems and abnormities ranging from age- related degenerative changes to herniated discs and spinal instability. 174 Medical Liability and Health Care Law March 2013

167 A. Spinal Stenosis Spinal pain and stenosis are terms frequently used together. Generally, stenosis means narrowing. When stenosis occurs within the spine, due to a disc protrusion or bony overgrowth, this narrowing may cause pressure upon the spinal cord or nerve roots. Stenosis commonly occurs in two areas: (1) within the vertebral canal of the spine through which the spinal cord and nerve roots run and (2) the intervertebral foramina through which the nerve roots leave the spine on their journey to other areas of the body. National Institute of Arthritis and Musculo-skeletal and Skin Disorders, Questions and Answers About Spinal Stenosis, available at (Last visited October, 21, 2010). About 75 percent of the time, this painful condition occurs in the low back and most often affects the structures that form the sciatic nerve, which runs along the back of the leg, hence the term sciatic. Surgery to correct stenosis is a decompression which takes the form of a foraminotomy, a laminectomy or a laminotomy. B. Spondylosis vs. Spondylolisthesis There are several words that start with spondylo that cause a great deal of confusion. Spondylo is Latin for vertebrae, so the term is obviously referring to a disorder involving that bony structure. Losis means a diseased condition, so spondylosis refers to a diseased condition of the vertebrae. Strictly speaking, the term spondylosis refers to a degenerative (i.e. normal aging) overgrowth of bone or spur formation. Spondylolisthesis is a much more complicated problem. Listhesis means to slip, so this term describes a vertebra that has slipped forward over the adjacent vertebrae. Spondylolisthesis most often occurs at the L4 and L5 levels. The pain from this condition may range from mild to severe or an individual may have no symptoms. Spondylolisthesis, PubMed Health, www. ncbi.nlm.nih.gov/pubmedhealth/pmh (Last visited July 26, 2012). Usually, this defect is caused either by an undetected fatigue fracture that makes the vertebra mechanically weak or because of a congenital defect. If spondylolisthesis cannot be controlled by conservative measures, such as with the use of a back brace and avoidance of bending and lifting, a spinal fusion is recommended. Gartland, Fundamentals of Orthopedics, 4 th ed. W.B.Saunders Co.; 1987; fn.10, at C. Herniated Disc When a disc is damaged, it may rupture or bulge. Herniated Disc Topic Overview, WebMD, If a full tear of the annulus occurs, pressure may force the liquid center to escape beyond the outer edge of the structure. This is called a herniated, protruding or slipped disc depending upon its appearance. A caramel crème candy offers a good example of a herniation. If the outside portion of the candy completely rips apart and the soft liquid center oozes out, a herniation has occurred. This condition exemplifies a herniated disc and can be the source of a great deal of back pain or a neurological abnormality like radiating pain down an extremity, weakness or loss of function. Hodge, Anatomy for Litigators, ALI-ABA, 2007 page 100. A discectomy is the most common procedure to correct this condition. V. Spinal Surgeries The mere fact that a person has a herniated disc is not cause for back surgery. Instead, surgery is usually limited to those who have something to operate on such as a significant disc herniation, have intractable pain, or suffer a neurological compromise such as leg weakness or loss of bladder or bowel control. Also, the type of surgery depends upon the reason for the procedure and each type of surgery can be performed a few different ways. Hodge and Hubbard, ABA Medical-Legal Guides: Clinical Anatomy for Lawyers, supra. Anatomy of the Spine: Back Surgery and Its Risks Hodge 175

168 A. Laminectomy and Laminotomy Ectomy means removal of, so a laminectomy is the removal of the part of the vertebra known as the lamina. On the other hand, otomy describes the making of an opening, so a laminotomy is a surgical procedure that creates an opening in the lamina. These procedures are performed to gain access to the spinal cord or nerve roots that are encased in bone and allow the surgeon to remove a herniated disc, to free up nerve compression caused by degenerative changes, or to access a spinal tumor. By removing the lamina, the soft tissue structures underneath are given unencumbered freedom. This surgery can also allow the physician to gain access to bone spurs in order to remove them. Hodge and Hubbard, ABA Medical-legal Guides: Clinical Anatomy for Lawyers, supra. In an open laminectomy, a several-inch incision is made down the center of the back and the exposed muscles are moved to the side. A portion of the lamina is then removed to alleviate the pressure on the appropriate nerve or spinal cord segment. When the procedure is completed, the lamina may be put back in place and the area is sutured. Id. A laminectomy does have certain inherent but limited risks. Nerve root damage can occur in one in a thousand cases, cerebrospinal fluid may leak if the dural sac has been compromised, and infection occurs in about one percent of any surgical procedure. Spinal instability may also surface in one to ten percent of laminectomies. Spine-Health.com, Lumbar Laminectomy Surgery for Spinal Stenosis (Open Decompression), is available at back-surgery/limbar-laminectomy-open-decompression (Last visited October 21, 2010). B. Discectomy A discectomy is the procedure of choice in repairing a herniated disc and involves the removal of a part of or the entire protruding disc: the nucleus pulpous. In the past, the procedure required a surgeon to make an extended incision of at least an inch in length to access the damaged disc. However, surgical advances allow for a number of alternative methods, such as a microdisectomy and laser discectomy that are less invasive. A microdisectomy is the same basic procedure as a discectomy, except a smaller incision is needed because a microscope is used to visualize the area. This results in less damage to the surrounding tissues and a shorter recovery time. A laser discectomy, a recent advance for removing a disc protrusion, involves placement of a small needle into the disc through fluoroscopic guidance. A laser is then inserted into the needle and threaded into the center of the nucleus to vaporize part of disc. This outpatient procedure reduces the volume of a diseased disc and the pressure within it and the surgery takes about 30 minutes to complete. emedicine, Patel, Laser Discectomy, available at neuro/topic683.htm (Last visited October 21, 2010). Studies have shown a success rate for laser discectomy of between 78 and 85 percent, with success defined as minimal back pain and the ability to return to work promptly. Id. C. Spinal Fusion A spinal fusion is the welding of two or more vertebrae together with either bone grafts or fixation devices, such as metal rods, to heal into a single unit. The result is a stabilized area created by several bones that form a solid unit. This procedure eliminates motion between the specific vertebrae and may be desirable when movement causes significant pain. Spinal fusion also halts the advancement of a spinal deformity such as scoliosis. Most surgeries of this type, however, involve relatively small spinal segments and do not signifi- 176 Medical Liability and Health Care Law March 2013

169 cantly limit motion. American Academy of Orthopaedic Surgeons, Spinal Fusion, available at aaos. org/topic.cfm?topic=a00348 (Last visited October 21, 2010). A fusion can be performed from the front or back depending upon the location of the surgery. A posterior approach is used when the operation is at the lumbar spine area. An anterior approach is the procedure most often used on the cervical spine. The bone graft utilized for the fusion may be taken from the hip or from a bone bank and the fusion can be held in place with screw, cages, rods or plates. A common complication of a spinal fusion is nonunion. This occurs in as many 56 percent of the fusions performed in the lumbar spine. Recognizing and treating this problem may be vital in preventing progressive deformity in identifying instrumentation failure, and in relieving chronic pain. C. Lee, J. Dorcil, and TE Radomisli, Nonunion Of The Spine: A Review, Clinical Orthop. Relat.Res Feb; (419):71-5. D. Corpectomy and Strut Graft Degenerative changes in the spine can put pressure on the spinal cord itself. One way of correcting this problem is to remove the degenerative vertebrae and replace it with a bone graft. This procedure is called a corpectomy and strut graft. All About Back and Neck Pain, Cervical Corpectomy and Strut Graft, available at spinesub_learn.asp?id=56 (Last visited October 21, 2010). E. Foraminotomy A foraminotomy is designed to increase the size of the opening where the nerve root exits the vertebral column. This area can be narrowed because of a variety of conditions ranging from degenerative changes to a herniated disc. Regardless of the cause, the result is the same: back pain. The foramen is enlarged by a drill or cutting tool to relieve the pressure on the nerve. VI. Common Complications from Back Surgery Infection is an inherent risk of back surgery especially when hardware and cadaver bone is used to keep the vertebral bone in place. Risks of Spinal Fusion, Livestrong.com. Literature reveals an infection rate of between 0 percent to 12 percent in these surgical patients, and this is a poor indication because it does not bode well for eventual improvement or future employability. Failed Back Syndrome, Wikipedia, en.wikipedia.org/wiki/failed_back_syndrome (last visited December 20, 2012). The rate of infection tends to increase with the sophistication of the procedure and as operating time increases. Id. Other common complications include spinal fluid leakage, especially if there is a puncture of the membrane that covers the spinal cord. These leaks can be corrected if noticed during surgery, and some leaks may correct themselves. If the problem is not corrected, the patient is at increased risk for a spinal fluid infection, headache and meningitis. Peter Ulrich, Jr., Laminectomy and Spinal Stenosis: Risks and Complications, Spine-Health. Another known complication of spinal surgery is nerve damage resulting in the loss of sensation or movement, and in rare cases, the autonomic nerves may be injured which can affect the lungs or heart. Id. Nicking or cutting of a nerve root, or damage from cautery or traction can also lead to chronic pain. Failed Back Syndrome, Wikipedia, supra. In defending a medical malpractice case involving failed back surgery, one must be mindful that even with the best physician, procedures, and outcomes, surgery is no more than 95 percent effective. In fact, in between 10 to 40 percent of patients, spinal surgery may not yield the anticipated benefits, and the individual may continue to experience pain, nerve damage, or may require subsequent back surgery in an attempt to remedy a previous operation or to address the problem that led to the original operation. Failed Back Surgery, Anatomy of the Spine: Back Surgery and Its Risks Hodge 177

170 Northwestern Memorial Hospital, (last visited December 20, 2012). Studies have also shown that certain conditions may increase the risk of a bad surgical outcome such as diabetes, autoimmune disorders and peripheral artery disease. Smoking is another risk factor to a successful outcome since nicotine interferes with the body s ability to heal bone, and the restriction of small blood vessels leads to scar formation. Id. Other conditions associated with failed back surgery include depression, anxiety disorders and substances abuse. Failed Back Surgery Syndrome, virtualmedcialcenter.com, virtualmedicalcentre.com/diseases/failed-back-surgery-syndrome-fbss/898 (last visited December 20, 2012). Therefore, these conditions should be an avenue of investigation by defense counsel. VII. Conclusion There has been a significant increase in spinal operations during the past two decades. However, these procedures are not without their risks. Surgical complications occur with more frequency in the lumbar spine and life-threatening complications increase with surgical complexities. The rate of infection increases with the sophistication of the procedure and longer operating room times. This risk of infection also increases with factors such as obesity, diabetes, smoking, previous infections and immunodeficiency. Understanding the anatomy of the spine, the manner in which the various surgical procedures are performed and the limitations of each operation will assist in defending the medical malpractice case involving operations to this anatomic area. 178 Medical Liability and Health Care Law March 2013