HEALTHTREK KERNICTERUS RISK IN 2010 HEALTH CARE PRACTICE WHAT IS KERNICTERUS? PEDIATRIC LIABILITY TRENDS

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KERNICTERUS RISK IN 2010 By Jacquelie Bezaire RN JD Paul A. Greve Jr. JD RPLU HEALTH CARE PRACTICE HEALTHTREK Jue 2010 www.willis.com WHAT IS KERNICTERUS?

1 KERNICTERUS RISK IN 2010 By Jacquelie Bezaire RN JD Paul A. Greve Jr. JD RPLU HEALTH CARE PRACTICE HEALTHTREK Jue WHAT IS KERNICTERUS? Kericterus is a very rare coditio afflictig full-term ad preterm ewbors. Caused by severe eoatal hyperbilirubiemia ( jaudice), it ofte has tragic cosequeces: death or profoud eurological impairmet. I The precise icidece of kericterus is ot kow, but studies show that, at a miimum, 10% of the eoates (a ewbor i the first days of life) with this rare diagosis will die ad 70% of those survivig will have lifelog impairmet. Treatmet is either phototherapy (so-called bili lights ) or, for severe cases, exchage trasfusios. II Treds i early post-partum hospital discharges begiig i the 1970s raised cocers i the pediatric commuity about the idetificatio ad treatmet of elevated bilirubi levels. These cocers caused the America Academy of Pediatrics (AAP) to promulgate treatmet guidelies i 1994 ad agai i The Natioal Quality Forum (NQF) deemed kericterus a ever evet. The Joit Commissio o Accreditatio of Healthcare Orgaizatios (JCAHO) has issued Setiel Evet Alerts o kericterus twice i the last decade (2001 ad 2004). Despite this icreased attetio to the problem ad the attempts to address it, kericterus cases still occur. III Recet articles i the pediatric literature suggest that kericterus ca occur eve whe appropriate care is provided. This article will focus o liability treds ad risk maagemet implicatios for kericterus. PEDIATRIC LIABILITY TRENDS The atioal medical malpractice eviromet remais stable i The idustry combied ratio idicates profitability, that claim frequecy has dropped markedly ad claim severity has moderated. The aalysis of atioal medical malpractice claim treds reveal two types of claims as problematic for severity: those arisig i either obstetric or pediatric settigs. There are three reasos for this. First, while eactmet of damage caps i may states sice 2000 has helped improve the atioal malpractice eviromet, o-ecoomic damage caps do ot help defedats very much i ay case ivolvig a severely ijured child. Secod, log-term survival of these childre has improved over the last 20 years due to medical advaces ad therefore the life-care plas are expesive, especially as health care costs have rise dramatically over the decades. Fially, the sympathy factor makes these cases difficult to defed, especially at trial. Four types of recurrig pediatric cases i the category of high frequecy/low severity are

2 particularly problematic: 1) meigitis, 2) malrotatio of the bowel/volvulus, 3) retiopathy of prematurity (ROP) ad 4) kericterus. Verdicts ad settlemets i these cases are ofte i multiple millios of dollars. The trial bar seeks out these high-damage cases through diverse advertisig strategies, especially through the iteret. IV Meigitis ad malrotatio of the bowel cases frequetly ivolve misdiagosis ad/or delayed treatmet. However, retiopathy of prematurity cases ad kericterus cases ofte ivolve system breakdows resultig i eoates ot receivig requisite iitial eye examiatios or subsequet follow-up examiatios (ROP); or iitial ad follow-up testig ad/or treatmet for jaudice/highly elevated bilirubi levels i the blood (hyperbilirubiemia) resultig i kericterus. ROP occurs oly i low birth-weight eoates treated i Level II or Level III Neoatal Itesive Care Uits (NICUs). Kericterus cases ca arise from eoates treated i ay ewbor ursery, ot just NICUs. All eoates, eve those full-term ad seemigly healthy at birth, are at risk for developig elevated bilirubi levels, which udetected ad/or utreated, ca become extreme hyperbilirubiemia ad result i kericterus, a rare but highly prevetable coditio, that maifests itself i profoud permaet eurological impairmet. V Despite icreased attetio from may atioal orgaizatios focused o patiet safety over the last 10 years, particularly the JCAHO, the NQF ad the AAP, kericterus cases still occur. VI Malpractice verdicts ad settlemets i kericterus cases, icludig those i recet years, are very large, almost always i multiple millios of dollars. POSTPARTUM CARE The icidece of kericterus prior to 1990 was very low, especially i full-term ifats. Possibly, the ow greater risk of exposure to high levels of hyperbilirubiemia i full-term ad ear-term ifats especially, is due to the greater umber of breast-feedig mothers with early post-partum hospital discharges (termed drive-thru deliveries ), icosistet post-discharge care ad follow-up, ad a lack of cocer about the dager of high bilirubi levels amog providers. IX A CLINICAL OVERVIEW Jaudice is ot ucommo i may ewbors; i most cases it is beig. However, due to the potetial euro-toxicity of bilirubi, ewbors must be moitored to idetify those at risk for severe hyperbilirubiemia ad those relatively few cases of ewbors at risk for acute bilirubi ecephalopathy, or kericterus. VII Kericterus is defied as a rare eurologic sydrome that results i severe brai damage or death of the affected ifat caused by exposure to hyperbilirubiemia (highly elevated levels of bilirubi). Highly elevated levels of bilirubi are euro-toxic i a developig eoate, as for some fullterm ifats ad especially for some pre-term ifats, the bilirubi crosses the blood brai barrier ad ca result i permaet brai damage. The AAP recommeded that the term kericterus be used solely for ifats that exhibit the sigs of chroic ad permaet cliical sequelae of bilirubi toxicity. VIII This paradigm shift i postpartum care ad the icreased icidece of breastfeedig created health care delivery system challeges that were ot immediately recogized ad addressed by providers. It is very importat for health care professioals to observe the ewbor for evidece of hyperbilirubiemia durig the period that the ifat is at risk, as set forth i AAP or America Academy of Family Practice (AAFP) cliical practice guidelies. 2 Willis North America 6/10

3 ADDRESSING THE PROBLEM 1994 AAP ISSUES A CLINICAL PRACTICE GUIDELINE FOR THE MANAGEMENT OF HYPERBILIRUBINEMIA IN HEALTHY, FULL-TERM NEWBORNS, RAISING KERNICTERUS AS A PEDIATRIC TREATMENT PROBLEM. X (The guidelies did ot ecessarily chage cliical practice immediately. However, a article by Burke et al. i Pediatrics i February 2009 covered their aalysis of Healthcare Cost ad Utilizatio (HCUP) data from , cocludig that there was a substatial reductio i hospitalizatios with a diagosis of kericterus i that time frame, although admittedly difficult to prove that the drop was due merely to the issuace of the guidelies. ) XI 1990s CONCERTED EFFORTS TO ADDRESS THE PROBLEM OF KERNICTERUS BEGIN WITH THE MAJIC PROJECT, A CONSORTIUM TO IMPROVE CARE FOR NEWBORNS WITH HYPERBILIRUBINEMIA FUNDED BY THE AGENCY FOR HEALTHCARE RESEARCH AND QUALITY AND INCLUDING THE AAP AND OTHERS. XII 2000 OCTOBER PARENTS OF INFANTS AND CHILDREN WITH KERNICTERUS (PICK) IS FOUNDED. (Oe of their primary goals is workig with health care delivery systems to help protect ewbors ad prevet future cases of kericterus, employig system-based approaches that iclude such measures as uiversal pre-discharge bilirubi screeigs.) XIII 2001 APRIL THE JCAHO ISSUES ITS FIRST SENTINEL EVENT ALERT (SEA) ON PREVENTION OF KERNICTERUS: KERNICTERUS THREATENS HEALTHY NEWBORNS. XIV 2002 THE NQF DEEMS KERNICTERUS A NEVER EVENT IN ISSUING ITS FIRST LISTING OF THESE INCIDENTS. The term Never Evet referred to particularly egregious medical errors (such as wrog-site surgery) that should ever occur. Over time, the list of Never Evets has bee expaded by NQF to sigify adverse evets that are uambiguous (clearly idetifiable ad measurable), serious (resultig i death or sigificat disability), ad usually prevetable. The NQF iitially defied 27 such evets i 2002, icludig death or disability (kericterus) associated with failure to idetify ad treat hyperbilirubiemia i eoates. XV 2004 JULY AAP ISSUES UPDATED CLINICAL PRACTICE GUIDELINE: MANAGEMENT OF HYPERBILIRUBINEMIA IN THE NEWBORN INFANT 35 OR MORE WEEKS OF GESTATION AUGUST JCAHO ISSUES ANOTHER SENTINEL EVENT ALERT PROVIDING REVISIONS FOR THEIR 2001 ALERT. XVI The JCAHO s revisios are based o the AAP July updated guidelies. AAP GUIDELINES The AAP guidelies suggest that if their recommedatios are followed by health care professioals, kericterus would be largely preveted. The guidelies also emphasize the importace of uiversal, systematic assessmet for the risk of severe hyperbilirubiemia, close follow-up ad prompt itervetio whe idicated. The recommedatios apply to the care of ifats at 35 or more weeks of gestatio ad seek to further the aims defied by the Istitute of Medicie as appropriate for health care: safety, effectiveess, efficiecy, timeliess, patiet-ceteredess ad equity. They specifically emphasize the priciples of patiet safety ad the key role of timeliess of itervetios to prevet adverse outcomes resultig from eoatal hyperbilirubiemia. XVII 3 Willis North America 6/10

4 FOLLOWING ARE KEY ELEMENTS OF THIS GUIDELINE. CLINICIANS SHOULD: 1. Promote ad support successful breastfeedig 2. Establish ursery protocols for the idetificatio ad evaluatio of hyperbilirubiemia 3. Measure the total serum bilirubi (TSB) or trascutaeous bilirubi (TcB) level o ifats jaudiced i the first 24 hours 4. Recogize that visual estimatio of the degree of jaudice ca lead to errors, particularly i darkly pigmeted ifats 5. Iterpret all bilirubi levels accordig to the ifat s age i hours MALPRACTICE CLAIM TRENDS Drs. Newma ad Maisels, i a joit letter to the editor of the joural Pediatrics, summarized the most commo issues i kericterus malpractice cases: Although quatitative literature o this poit is admittedly sparse, the causal relatioship betwee hyperbilirubiemia ad kericterus is geerally ot disputed. I our experiece, however, most malpractice cases ivolvig kericterus do ot revolve aroud the questio of whether a specific bilirubi level produced brai damage or whether a itervetio at a lower bilirubi level would have preveted the damage. More commoly, cases ivolve ifats admitted to the hospital with bilirubi levels of >35 mg/dl who maifest the classical sigs of acute bilirubi ecephalopathy. I these cases it ca be asserted that with reasoable medical probability that if this ifat had bee see ad treated earlier, the bilirubi would ot have rise to dagerous levels ad the kericterus could have bee preveted. Whether someoe is to blame for this sequece of evets, however, is ofte the most cotetious issue, ad specifically whether there was a breech i the stadard of care. XVIII The first decade of the 21 st cetury has see malpractice verdicts ivolvig kericterus with very large settlemets. The table below cotais selected settlemets we are aware of. It is based o our ow iformal research ad does ot represet all court verdicts. KERNICTERUS MEDICAL MALPRACTICE VERDICTS/SETTLEMENTS DATE LOCATION AMOUNT (i millios) 12/09 Califoria $5 7/07 Califoria $15.4 4/06 Bosto $5 4/04 Chicago $30 Ukow Miesota $ Willis North America 6/10

CASE IN POINT Allegatio: The plaitiff alleged that several defedat physicias failed to diagose ad treat jaudice i a ewbor ifat i the first weeks of life, resultig i severe, lifelog brai damage.

5 CASE IN POINT Allegatio: The plaitiff alleged that several defedat physicias failed to diagose ad treat jaudice i a ewbor ifat i the first weeks of life, resultig i severe, lifelog brai damage. I this case, a ewbor healthy baby was discharged from the hospital without ay istructios to the mother about the sigs ad symptoms of jaudice, such as abormal colorig ad difficulty feedig. Evidece discovered by cousel showed that, at the time the ifat was discharged from the hospital the day after birth, photographs take by the family showed differeces i ski color, which should have led the physicias to recogize the developmet of jaudice. The baby s jaudice wet uoticed ad utreated by her doctors. Whe the ifat was five days old, the pediatricia, who was scheduled to see the patiet at two weeks of age, was iformed of feedig problems ad ski ad eye discoloratio. The mother was istructed to take the ifat to the hospital the followig morig for bilirubi testig for jaudice. However, the urget eed for testig was ot commuicated to the parets. Several crucial hours passed before the child was brought i for testig A exchage trasfusio was ordered but was ot carried out for seve hours. SETTLEMENT: $5 MILLION The theories drivig the verdict of $5 millio dollars i the case were: Failure to istruct the mother at the time of discharge o the sigs of eoatal jaudice Failure of the pediatricia to stress the eed for immediate testig to the parets Failure of the hospital to perform the exchage trasfusio i a timely maer XIX RISK MANAGEMENT TECHNIQUES Techiques for prevetig kericterus revolve aroud proper patiet istructios, early diagosis ad prompt itervetio. The AAP has toolkits available for hospitals ad physicias offices that iclude discharge readiess checklists, follow-up letters, ivetories, assessmets ad documetatio tools ad paret hadouts. XX Discharge assessmet for risk factors for developig hyperbilirubiemia should be doe ad documeted. Discharge istructio for kericterus must iclude documetatio that the parets uderstad the sigs ad symptoms of jaudice as well as the emergecy ature of this coditio. Parets eed to be istructed o hyperbilirubiemia ad whe to call the physicia. Testig must be doe i a timely maer ad treatmet istituted immediately. Compliace with the AAP Guidelie (most curret versio as of this publicatio is the 2004 Guidelie) is essetial to establish practice withi the curret stadard of care, although recet fidigs as set forth below suggest that ot all cases ca be preveted. Providers ca help promote patiet safety by beig curret with the latest medical literature fidigs. 5 Willis North America 6/10

6 RECENT DEVELOPMENTS Now, i 2010, there is some questio as to whether kericterus should have bee deemed a ever evet. The implicatio by the NQF was that if elevated bilirubi levels were moitored appropriately ad there was timely itervetio (primarily phototherapy ad, for severe cases, exchage trasfusios), kericterus could be elimiated. Because of recet articles, the curret state of cliical kowledge regardig the kericterus problem is more muddled. Over the last year, authors such as Maisels et al. state that while elimiatio of all cases of kericterus is a worthy goal, certai cliical presetatios, such as a particular glucose deficiecy (called G6PD), a geetic predispositio, sepsis ad other ukow stressors may cause severe hyperbilirubiemia ad ca produce brai damage despite appropriate moitorig ad itervetio. XXI I that same October 2009 issue of Pediatrics, Trikalois et al. suggested that although screeig ca predict hyperbilirubiemia, there is o robust evidece to suggest that screeig is associated with favorable cliical outcomes. XXII The U.S. Prevetive Services Task Force wet eve further i a Recommedatio Statemet issued i October 2009 cocludig the evidece is isufficiet to recommed screeig ifats for hyperbilirubiemia to prevet chroic bilirubi ecephalopathy (kericterus). They go o to state that: Early treatmet ca decrease the umber of ifats with elevated serum bilirubi levels. However, the USPSTF foud iadequate evidece that treatig elevated bilirubi levels i term or ear-term ifats to prevet severe hyperbilirubiemia resulted i the prevetio of chroic bilirubi ecephalopathy. XXIII The USPSTF also challeges the cliical coectio betwee hyperbilirubiemia ad kericterus i every case, XIV ad states that ot all childre with chroic bilirubi ecephalopathy have a history of hyperbilirubiemia. XV Maisels et al. recommed i their article that that at preset, ad util there is more cliical evidece, all ewbors receive pre-discharge screeig ad the follow-up maagemet as recommeded by the AAP i the absece of better evidece. XVI They state: it is our opiio that uiversal screeig, whe combied with the cliical risk factors (of which gestatioal age ad exclusive breastfeedig are most importat) ad targeted followup, is a systems approach that is easy to implemet ad uderstad, ad it provides a method of idetifyig ifats who are at high or low risk for the developmet of severe hyperbilirubiemia. XVII Debate cotiues i the pediatric commuity o the approach to prevetig kericterus. The curret use of TBS screeig was challeged i the same October 2009 issue of Pediatrics by Fay et al., suggestig that the TBS test is flawed due to sample, subject follow up, ad the fact that positive hyperbilirubiemia test results did ot always correlate with kericterus. CONCLUSION Kericterus is a devastatig disorder that ca result i lifelog disability or death of a child. The magitude of this problem has bee recogized by both the AAP ad the Joit Commissio o Accreditatio of Hospitals. JCAHO issued Setiel Evet Alerts after guidelies had bee created by AAP. Kericterus cases are a area of specialty for may plaitiffs lawyers due to the severe ature of the disorder ad potetially expesive life-care plas. But recet fidigs suggest that at least some of these cases may be successfully defeded o a causatio basis if there is compliace with curret screeig ad treatmet guidelies. Effective assessmet of the ewbor for risk factors, timely testig ad thorough discharge plaig are essetial i prevetig may cases of kericterus, but recet articles i the pediatric literature suggest that ot all cases ca be preveted, eve with optimal screeig ad follow-up. Compliace with the AAP guidelies is essetial to kericterus prevetio ad creatig a defesible case at preset, although advacemets i the uderstadig ad treatmet of the effects of hyperbilirubiemia o kericterus will alter these guidelies i the future. 6 Willis North America 6/10

7 I Ip,S, Chug M.,Kulig, J, O Brie, R. et al., A evidece-based review of importat issues cocerig eoatal hyperbilirubiemia, Pediatrics, Vol 114, No.1, 2004, (abstract) pp. 130, July II US Prevetive Services Task Force, Screeig of Ifats for Hyperbilirubiemia to Prevet Chroic Bilirubi Ecephalopathy: US Prevetive Services Task Force Recommedatio Statemet, Pediatrics, Vol.124, No.4, October 2009, pp , at III Fay, David L. M.D. et al., Bilirubi Screeig for Normal Newbors: A Critique of the Hour-Specific Bilirubi Nomogram, Pediatrics, Vol. 124, No.4, October 2009, pp , at IV Author s ote: Usig Google or other search egies to search o the key words kericterus ad malpractice will result i a legthy listig of a umber of plaitiff s law firm sites, such as New Jersey Jaudice Lawyers. V Setiel Evet Alert, Revised Guidace to Help Prevet Kericterus, Issue 31, August 31, 2004, JCAHO. VI Fay et al., Ibid, p VII AAP, Cliical Practice Guidelie, Maagemet of Hyperbilirubiemia i the Newbor Ifat 35 or More Weeks of Gestatio, Pediatrics, Vol.114, No.1, July 2004, pp , ad pp at p. 1. VIII Ibid., p.3 IX Harris, Mary Catherie M.D. et al., Developmetal Follow-Up of Breastfed Term ad Near-Term Ifats with Marked Hyperbilirubiemia, Pediatrics, Vol.107, No.5, May 2001, pp , at X Ibid. XI Burke, Brya M.D. et al., Treds i Hospitalizatios for Neoatal Jaudice ad Kericterus i the Uited States, , Pediatrics, Vol.123, No.2, February 2009, pp , at 531. XII Ibid. XIII Sherida, Susa, Parets of Ifats ad Childre with Kericterus, Joural of Periatology, Vol.25, No , pp , at 227. XIV Setiel Evet Alert, JCAHO, Issue 18, April XV AHRQ, Never Evets, XVI Setiel Evet Alert, JCAHO, Issue 31, August XVII The Joit Commissio, Revised Guidace to Help Prevet Kericterus XVIII Maisels, M. Jeffrey M.D. ad Newma, Thomas B. M.D., Kericterus, the Daubert Decisio, ad Evidece-Based Medicie, Letter to the Editor, Pediatrics, Vol.119, 2007, at p.1038,available at XIX Verdicts ad Settlemets XX America Academy of Pediatrics, XXI Maisels, M. Jeffrey et al., Hyperbilirubiemia i the Newbor Ifat >35 Weeks Gestatio: A Update with Clarificatios, Pediatrics, Vol.24, No. 4, October 2009, pp , at XXII Trikalois, Thomas A. M.D. et al., Systematic Review of Screeig for Bilirubi Ecephalopathy i Neoates, Pediatrics, Vol124, No.4, October 2009, pp , at XXIII US Prevetive Services Task Force, Screeig of Ifats for Hyperbilirubiemia to Prevet Chroic Bilirubi Ecephalopathy: USPSTF Task Force Recommedatio Statemet, Pediatrics, Vol.124, No.4, October 2009, pp , at XXIV Ibid at XXV Ibid at XXVI Maisels et al. at XXVII Ibid. XXVIII David L. Fay, M.D., Keeth G. Schelhase, M.D., MPH, ad Gautham K. Suresh, Bilirubi Screeig for Normal Newbors: A critique of the hour-specific Bilirubi Nomogram, Pediatrics, Vol 124, Number 4, October Willis North America 6/10

8 CONTACTS For further iformatio, please visit our website o willis.com or cotact ay of the followig: Mary S. Botki Practice Leader Housto, TX mary.botki@willis.com Deaa Alle Atlata, GA deaa.alle@willis.com Pamela Haughawout Chicago, IL pamela.haughawout@willis.com Neil Morrell Chicago, IL eil.morrell@willis.com Sady Berkowitz Malver, PA sady.berkowitz@willis.com Paul A. Greve, Jr. Nashville, TN paul.greve@willis.com E. Dow Walker, Jr. Nashville, TN dow.walker@willis.com Jacquelie Bezaire Los Ageles, CA jacquelie.bezaire@willis.com Frak Castro Los Ageles, CA frak.castro@willis.com Ke Felto Hartford, CT keeth.felto@willis.com The observatios, commets ad suggestios we have made i this report are advisory ad are ot iteded or should they be take as medical/legal advice. Please cotact your ow medical/legal adviser for a aalysis of your specific facts ad circumstaces. 8 Willis North America 6/10

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