How To Review Tonsillectomy And Other Complications

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1 Pediatric Anesthesia ISSN ORIGINAL ARTICLE Anesthesia- and opioids-related malpractice claims following tonsillectomy in USA: LexisNexis claims database Rajeev Subramanyam 1, Vidya Chidambaran 1, Lili Ding 2, Charles M. Myer III 3 & Senthilkumar Sadhasivam 1 1 Department of Anesthesia, Cincinnati Children s Hospital Medical Center, Cincinnati, OH, USA 2 Division of Biostatistics and Epidemiology, Cincinnati Children s Hospital Medical Center, Cincinnati, OH, USA 3 Division of Pediatric Otolaryngology-Head and Neck Surgery, Cincinnati Children s Hospital Medical Center, Cincinnati, OH, USA Keywords tonsillectomy; malpractice; database; anesthesia; opioids; complications Correspondence Rajeev Subramanyam, Assistant Professor, Department of Anesthesia, Cincinnati Children s Hospital Medical Center, 3333 Burnet Avenue, MLC 2001, Cincinnati, OH 45229, USA rajeev.subramanyam@cchmc.org Section Editor: Jerrold Lerman Accepted 29 November 2013 doi: /pan This was presented as an abstract at Society of Pediatric Anesthesia Meeting at Las Vegas, The abstract was selected as the first prizewinner of the American Academy of Pediatrics John J. Downes Resident Research Award. Summary Background: Although commonly performed, tonsillectomy is not necessarily a low-risk procedure for litigation. We have reviewed malpractice claims involving fatal and nonfatal injuries following tonsillectomy with an emphasis on anesthesia- and opioid-related claims and their characteristics. Methods: Tonsillectomy-related malpractice claims and jury verdict reports from the United States (US) between 1984 and 2012 found in the LexisNexis MEGA TM Jury Verdicts and Settlements database were reviewed by two independent reviewers. LexisNexis database collects nationwide surgical, anesthesia, and other malpractice claims. Data including years of case and verdicts, surgical, anesthetic and postoperative opioid-related complications, details of injury, death, cause of death, litigation result, and judgment awarded were analyzed. When there were discrepancies between the two independent reviewers, a third reviewer (SS) was involved for resolution. Inflation adjusted monetary awards were based on 2013 US dollars. Results: There were 242 tonsillectomy-related claim reports of which 98 were fatal claims (40.5%) and 144 nonfatal injury claims (59.5%). Verdict/ settlement information was available in 72% of cases (n = 175). The median age group of patients was 8.5 years (range 9 months to 60 years). Primary causes for fatal claims were related to surgical factors (n = 39/98, 39.8%) followed by anesthesia-related (n = 36/98, 36.7%) and opioidrelated factors (n = 16/98, 16.3%). Nonfatal injury claims were related to surgical (101/144, 70.1%), anesthesia (32/144, 22.2%)- and opioid-related factors (6/144, 4.2%). Sleep apnea was recorded in 17 fatal (17.4%) and 15 nonfatal claims (10.4%). Opioid-related claims had the largest median monetary awards for both fatal ($ ) and nonfatal injury ($ ) claims. Conclusions: Tonsillectomy carries a high risk from a medical malpractice standpoint for the anesthesiologists and otolaryngologists. Although surgery-related claims were more common, opioids- and anesthetic-related claims were associated with larger median monetary verdicts, especially those associated with anoxic, nonfatal injuries. Caution is necessary when opioids are prescribed post-tonsillectomy, especially in patients with sleep apnea. 412

2 R. Subramanyam et al. Anesthesia and opioid related malpractice claims Introduction Tonsillectomy is a very commonly performed ambulatory procedure in the United States with about surgeries carried out every year (1). The two most common indications for tonsillectomy include sleep disordered breathing and recurrent throat infections (2). The indications have changed from primarily being infection in the 1970s to sleep disordered breathing over the last three decades (3). Recent Childhood Adenotonsillectomy Trial concluded that adenotonsillectomy improves behavior outcomes, quality of life, and polysomnographic findings in children with obstructive sleep apnea (4,5). Surgical complications like hemorrhage, soft tissue injuries, and others are well recognized and reported following tonsillectomy (6 12). Analysis of malpractice claims has been described after surgical complications with hemorrhage being a predominant cause of mortality following tonsillectomy (13 16). Mortality rates for tonsillectomy have been estimated at between 0.63/ (1 in ) to 0.29/ (1 in ) based on data from the 1970s (17). A more recent European survey showed a post-tonsillectomy mortality rate of per , albeit with certain limitations of defining the denominator (18). Mortality following tonsillectomy appears unchanged over four decades despite improved monitoring technology and emphasis on patient safety. Tonsillectomy is also listed as a cause for perioperative cardiac arrest and death due to anesthetic causes (19 21). In a malpractice claims review, mean monetary awards against anesthesiologists were more frequent and higher than surgeons (15). In the LexisNexis database review from our institution that focused on details regarding surgical claims after tonsillectomy, it was reported that monetary awards were highest for anoxic events and medication use (14). The present study is an important extension as it includes 2012 LexisNexis MEGA TM Jury Verdicts and Settlements database claims assessment and uniquely focuses on anesthetic and opioid related complications after tonsillectomy. Besides including all cases over a period of 28 years with a renewed focus, we also report inflation adjusted monetary awards adjusted for 2013 US $. Insight regarding medico legal risk related to anesthesia and recovery after this very common surgery in children is essential to improve perioperative safety and care for these patients. Methods This study was exempt from Institutional Review Board Approval because no human subjects were studied and no patient health information was reviewed. LexisNexis MEGA TM Jury Verdicts and Settlements database (Dayton, OH, USA) was searched using MeSH terms tonsillectomy and malpractice between 1984 and LexisNexis database LexisNexis malpractice database is a nationwide database that collects various surgical, anesthesia and other malpractice claims from all over the United States of America. The database includes information about clinical problems, case summary, plaintiffs, defendants, injury, method of resolution, state and city of origin of case, court location, awards and its details if any, as well as the plaintiff and defendant counsel. The case summary section provided details about the patient and the circumstances under which the death or injury occurred. There were one or more experts on each case and the specialty areas of experts were provided in the database. Data collection Two investigators reviewed the database independently (RS and VC), and any discrepancy was resolved with a third reviewer (SS). A data collection tool was developed to uniformly record information from the database on plaintiff (patient) characteristics, complications, settlement information, and monetary awards. The plaintiff data including age of patients, gender, and comorbidities were collected. Sleep apnea is the most comorbid condition present in tonsillectomy cases, and hence, more information was collected on this comorbid condition. Complications were classified into fatal injuries and nonfatal injuries. Claims were evaluated and categorized by the type of complication from which the claim evolved: surgery related, anesthesia related, and opioids related. Surgery related was defined as a complication that originated from the action of a surgeon or if the surgeon was the defendant. Anesthesia related was defined as a complication that originated from the action of an anesthesiologist or if the anesthesiologist was the defendant. Opioid related was defined when there was a description of opioid implicated in the case, when the case had clearly recorded postoperative respiratory depression or respiratory failure or respiratory arrest. Some of the claims had more than one factor and were included in multiple relevant categories. Those claims that were not categorized into any of these and were still relevant to tonsil surgery were defined as Uncategorized. The surgical procedure, details of fatal and nonfatal injury complications, causes of the events, 413

3 Anesthesia and opioid related malpractice claims R. Subramanyam et al. the place where the event occurred, and timing of the events were recorded. Settlement information of the cases was collected. The year of the surgery and the year when the verdict passed were collected. The number of cases where the surgeon, anesthesiologist, or both, or hospital was collected with both fatal and nonfatal injury claims independently. The judgment information is based on the defendant, verdict passes, and whose favor the settlements were made. Monetary award data were collected for all three categories based on fatal and nonfatal injury claims. To make uniform dollar amount comparisons, inflation adjusted monetary awards were calculated based on the Consumer Price Index, which represents changes in prices of all goods and services purchased for consumption by urban households. The inflated adjusted amount is constant 2013 US $, where the latest monthly index values were used. Year of verdicts were used to calculate the inflated amount from United States Bureau of Labor Statistics. Results The database search returned 422 jury verdict reports for claims related to tonsillectomy. Duplicate entries and claims not related to tonsillectomies were excluded. Those reports with additional surgeries were included only if tonsillectomy was the cause for claims. Data were analyzed on 242 tonsillectomy related claim reports on the database between 1984 and 2012 (Figure 1). Of 242 claims, 98 were fatal claims (40.5%) and 144 were nonfatal injury claims (59.5%) (Table 1). The database was Table 1 Categories of fatal and nonfatal injury claims Fatal injury claims n (%) analyzed with descriptive statistics with number (n) and percentages (%) for categorical variables; and mean, median, and quantiles for continuous variables. Plaintiff (patient) characteristics Nonfatal injury claims n (%) 98 (40.5%) 144 (59.5%) Surgery related 39 (39.8%) 101 (70.1%) Anesthesia related 36 (36.7%) 32 (22.2%) Opioid related 16 (16.3%) 6 (4.2%) Uncategorized 17 (17.4%) 9 (6.3%) Some claims had overlapping causes between the surgery-, anesthesia-, and opioid-related categories. The median age group of patients was 8.5 years (Mean SD: years; minimum age 9 months and maximum age 60 years). The median age of fatal group was 7 years (minimum age 1.6 years and maximum age 53 years), and nonfatal group was 14 years (minimum age 9 months and maximum age 60 years). The most common patient comorbidity recorded was the presence of obstructive sleep apnea, which occurred in 17.4% of fatal and 10.4% of nonfatal injury claims. Asthma (n = 3), obesity (n = 3), smoking (n = 2), anemia (n = 1), coexisting liver disease (n = 1), Down syndrome (n = 1), pulmonary hypertension (n = 1), rheumatic carditis (n = 1), sickle cell disease (n = 1), and upper respiratory infection (n = 1) were some of the other comorbidity information that was available. Perioperative complications The most common cause of fatal injury claims were surgical related, followed by anesthesia and opioid related. The most common cause of nonfatal injury claims was also surgery related. This was followed by anesthesiarelated and opioid-related factors. Among nonfatal injury claims the surgical related far outweighed anesthesia- and opioid-related claims (Table 1). The list of factors for which the claims originated in each of the categories is summarized in Table 2. Figure 1 This is a flow chart of database analysis showing the exclusions and the total claims analyzed. Surgery-related complications Bleeding was the most common over all cause of surgical-related claims and accounted for the majority of surgery-related fatal injury claims (23%). The most common cause of surgery-related nonfatal injury claims was soft tissue injury that caused about 21% of all 414

4 R. Subramanyam et al. Anesthesia and opioid related malpractice claims Table 2 Complications that were associated with malpractice claims Main variable Factors Fatal injury claims (n = 98) n (%) Nonfatal injury claims (n = 144) n (%) Surgical Bleeding 23 (23.5) 18 (12.5) Burn injury* 0 19 (13.2) Infection 0 3 (2.1) Medication 7 (7.1) 3 (2.1) Soft-tissue injury 0 30 (20.8) Others 10 (10.2) 13 (9.0) Anesthesia Airway or oral fire/burns* 0 7 (4.9) Adult respiratory 1 (1) 0 distress syndrome Arrhythmias 0 1 (0.7) Aspiration 4 (4) 2 (1.4) Below standard of care 1 (1) 0 Bronchospasm 1 (1) 1 (0.7) Cardiorespiratory 1 (1) 1 (0.7) failure/arrest Difficult airway 5 (5.1) 5 (3.5) Fluid overload 1 (1) 0 Hypoxic brain damage** 2 (1.3) Inadequate anesthesia 0 1 (0.7) No consent 1 (1) 0 Malignant hyperthermia 0 1 (0.7) (Halothane) Non opioid medications 4 (4) 4 (2.1) Negligent intraoperative 1 (1) 4 (2.1) monitoring Pulmonary edema 3 (3.1) 0 Seizures 1 (1) 0 Sepsis 1 (1) 0 Soft tissue/bone/ 0 4 (2.1) teeth injury Opioids 17 (17.4) 9 (6.3) *The total burn injuries include 26 cases of which seven were burns related to airway fire and 19 were burns related to cautery use. **Hypoxic brain injury is not included among fatal injury claims as this was thought to be the common pathway for all deaths. nonfatal injury claims. This was followed closely by burn injuries (13%) and bleeding (12.5%) among nonfatal injury claims. Anesthesia-related complications The largest contributor of claims for both fatal and nonfatal injury claims was medications and difficult airway. The list of other anesthesia factors that originated claims is summarized in Table 2. There were 10 claims related to difficult airway and six of them had further details: three were related to bleeding and inability to intubate, one had a cervical spine injury, one had unanticipated difficult airway, and one inability to open the mouth. Airway fires resulting form cautery use resulted in 4.9% of nonfatal injury claims. Opioid-related complications A total of 16.3% fatal injury claims and 4.2% nonfatal injury claims were associated with the use of opioids. Of the 16 opioid-related fatal claims, 15 deaths occurred in the postoperative period (data was missing for one claim). Of these, there were three hospital deaths and two home deaths on postoperative day 0, and one hospital death and one home death on postoperative day 1. Of the six opioid related nonfatal claims, two of them occurred in postanesthesia care unit and two in the postoperative period. Locations of the remaining children were not included in the databank. Among fatal injury claims, morphine and codeine were the opioids that were most commonly implicated. Opioids implicated in the claims and their characteristics are summarized in Table 3. The injury event place (hospital or home) and time (intraoperative or postoperative) of occurrence are detailed in Table 4. Uncategorized Uvular surgery plus tonsillectomy was associated with eight fatal claims and 10 nonfatal claims. Settlement information and defendant (surgeon, anesthesiologists, hospital) characteristics Verdict/settlement information was available for 175 of 242 cases (72%). The median time from time of injury to time of verdict was 4 years for fatal claims and 3 years for nonfatal claims. The defendant information is further characterized in Table 4. Monetary awards The surgery-related claims outnumbered anesthesia- and opioids-related claims. However, the monetary awards based on inflation adjusted 2013 US $ was higher for anesthesia- and opioid-related claims for both fatal and nonfatal injuries as compared to surgical claims. Opioid-related claims had the largest median monetary awards for fatal ($ ) and nonfatal injury ($ ) claims. Similar to opioid-related awards, median monetary awards for anesthesia-related nonfatal injuries ($ ) were higher than anesthesia-related fatal injuries ( ) (Table 5). The monetary awards of more than $ (2013 inflation adjusted US $) related to opioids occurred in children <7 years of age (Table 6). Specific examples of cases described in Table 6 are provided in (Table S1) as explained in the original database. 415

5 Anesthesia and opioid related malpractice claims R. Subramanyam et al. Table 3 Characteristics of medication-related claims Sr. No. Opioids Year of Injury Year of verdict Age (year) Sex Comorbidities Type of additional procedure Event Place POD Case settled in favor of Settlement amount (US $) Inflated adjusted amounts (2013 US $) Comment 1 Morphine + Codeine Male OSA Septoplasty, UVP 2 Plaintiff Morphine intoxication due to incorrect prescription 2 Morphine Male OSA None Home 0 Anesthesiologist None Morphine intoxication. Unresponsive after sleep. 3 Morphine Female OSA None Hospital 0 Plaintiff Settled for a confidential amount outside the court 4 Morphine 1998 Septal reconstruction Hospital 0 Others Mixed settlement, Died 1 h after morphine. 5 Morphine None Morphine overdose. 6 Meperidine 2004 None Others Mixed case resolution. 7 Meperidine + Promethazine Male OSA None Home 0 Plaintiff Opioid overdose 8 Fentanyl patch Respiratory arrest. Other type of case resolution 9 Fentanyl patch None Surgeon Unsure about who prescribed fentanyl patch OSA, obstructive sleep apnea; POD, Postoperative day; UVP, uvulopharyngoplasty; : Data not available. All events occurred postoperatively. 416

6 R. Subramanyam et al. Anesthesia and opioid related malpractice claims Table 4 Injury events place, time, and settlement summary Main variables Discussion Factors Fatal injury claims n (%) Nonfatal injury claims n (%) Event place Hospital 25 (25.5) 50 (34.7) Home 9 (9.2) 1 (0.7) Event time Intraoperative 12 (12.2) 55 (38.2) Postoperative 51 (52) 27 (18.8) Both 1 (1) 1 (0.7) Post anesthesia 0 2 (1.4) care unit Defendant Anesthesiologist 21 (21.4) 20 (13.9) Surgeon 28 (28.6) 92 (63.9) Both 34 (34.7) 21 (14.6) Hospitals/institutions 6 (6.1) 3 (2.1) Verdict Settlement/verdict 62 (63.3) 105 (72.9) passed Mistrial 2 (2) 1 (0.7) Ongoing trial 2 (2) 4 (2.8) Voluntary dismissal 3 (3) 2 (1.4) In favor of Plaintiff 20 (20.4) 30 (20.8) Anesthesiologist 6 (6.1) 4 (2.8) Surgeon 9 (9.2) 35 (24.3) Anesthesiologist and 15 (15.3) 10 (6.9) surgeon Others 5 (5.1) 4 (2.8) Our malpractice database review of claims related to tonsillectomy showed that anesthesia- and opioidrelated claims are associated with larger median monetary verdicts than surgery-related claims. The median monetary claims for nonfatal injuries were higher than those of fatal injuries. Although the number of surgery-related claims outnumbered other categories, awards against anesthesiologists were reported to be more frequent and higher than against surgeons (15), which is consistent with our results from the LexisNexis database review. About 16.3% of fatal injuries and 4.2% of nonfatal injuries were related to opioids in our study. A report from the Physician Insurers Association of America had a similar observation with more number of medication-related injuries resulting from use of intravenous opioids (16). Another report from New York state insurance cases identifies postoperative respiratory depression as the most common cause of death or major injury in 36% of claims and intraoperative medication related events were implicated in 8% of claims (15). Unlike our study, both these reports did not focus on anesthesia related claims. However, it underscores the importance of medications and respiratory events in tonsillectomy related malpractice claims. There are no recent tonsillectomyspecific anesthesia closed claim studies in the literature. Early reports from the Committee on Professional Liability of the American Society of Anesthesiologists (ASA), claims from Europe, and ASA Closed Claims Project Database examining 980 closed claims for deaths that occurred in 1990 or later have shown the importance of respiratory disturbances and medications in malpractice claims (22 25). Recent electronic surveys of death and disability after tonsillectomy have shown that events unrelated to bleeding contributed to majority of deaths and anoxic brain injury and postoperative respiratory monitoring should be continued through first postoperative night in children with sleep apnea (6,26). Our finding supports their conclusions and also provides a direction for refocusing our thinking about the risks of tonsillectomy. Tonsillectomy is a very commonly performed surgery in children. However, tonsillectomy is associated with complications such as life-threatening bleeding, multiple reports of opioid-related anoxic injuries and deaths, and difficult and esophageal intubations (27,28). In this manuscript, we highlight that this common outpatient procedure is associated with anesthesia- and opioid-related malpractice claims at surprisingly higher frequencies than typically estimated or anticipated by anesthesiologists. In addition to pediatric tonsillectomy-related claims in the review, we also reviewed adult tonsillectomy-related claims. Table 5 Inflated adjusted monetary awards for deaths and injuries Fatal injury claims Non-fatal injury claims Main variable N Awards (2013 US $) N Awards (2013 US $) Anesthesia related ( ) ( ) Opioid related ( ) ( ) Surgical related ( ) ( ) Uncategorized ( ) Total ( ) ( ) Data is Median (Inter quartile range). Dollar amounts are rounded off to nearest whole numbers. Not all claims mentioned in Table 1 resulted in monetary awards. 417

7 Anesthesia and opioid related malpractice claims R. Subramanyam et al. Table 6 Characteristics of opioid-related postoperative events claims in children with monetary awards of more than $ (inflated adjusted) Serial No. Year of verdict Age (year) Sex Comorbidities Injury Event time Event place Settlement amount (US $) Inflated adjusted amounts (2013 US $) Notes M OSA; Obesity F Postop Home Codeine M OSA F Postop Codeine F Opioids F Postop Hospital Opioids M OSA, Asthma, Anemia NF PACU Hospital Opioids and Persistent vegetative state M OSA NF Postop Opioids Anesth, Anesthesiologist; Both: Anesthesiologist and surgeon; Injury F, fatal injury; Injury NF, nonfatal injury; Intraop, Intraoperative; OSA, obstructive sleep apnea; PACU, postanesthesia care unit; Postop, Postoperative; Gender M: Male; Gender F: Female. The role of sleep apnea in tonsillectomy-related malpractice claims is controversial based on two recent reports (6,26). In a medico legal analysis of 100 malpractice claims against bariatric surgeons in patients with a mean age of 40 years and body mass index of <60 in 81%, sleep apnea was recorded in 38% (29). In our database, sleep apnea was present in 16.3% of fatal claims and 4.2% of nonfatal claims. With an increase in ambulatory surgeries and sleep apnea becoming one of the foremost indications for tonsillectomy, anesthesiologists are exposed to increased and new areas of liability (30). In the authors experience, screening patients for sleep apnea and a careful history to preoperatively assess symptoms of sleep apnea is important (31 33). As there are no clinical metrics in children that diagnose sleep apnea apart from a true polysomnography, the diagnosis based on clinical symptoms alone may underdiagnose a significant proportion of sleep apnea. Some of the potential areas identified are care of patients with sleep apnea, postoperative discharge, which still lacks conclusive evidence in tonsillectomy, and other anesthetic techniques (12,30). Earlier research had shown that increased opioid sensitivity likely due to altered mu receptors from recurrent bouts of hypoxemia makes a normal dose of opioid a relative over dose in children with sleep apnea (34). Younger age children with sleep apnea having tonsillectomy have increased rate of postoperative complications (35,36). Recent study showed that racial differences play a unique role in opioidrelated adverse events. Caucasian children received less opioid doses, but had more opioid related adverse events than African American children after tonsillectomy (37). We also observed more monetary award with nonfatal injuries than fatal injuries. This can be related to 418 ongoing expense for continued medical care of these patients and the emotional trauma the family suffers all along. In our legal claims, the frequently reported opioids associated with claims included codeine, morphine, fentanyl, and meperidine. Despite its well-known efficacy and safety problems, codeine was one of the most commonly prescribed opioid for home pain management after adenotonsillectomy in the United States because of its availability in most of the pharmacies and its perceived margin of safety (38). Recent black box warning issued against the use of codeine following tonsillectomy in children in February 2013 by Food and Drug Administration (FDA) highlights the importance of risks associated with codeine following tonsillectomy (39). Codeine is a pro-drug and has to be converted in the liver by cytochrome P450 2D6 (CYP2D6) enzyme to its active analgesic metabolite, morphine. There are 13 adverse events (10 deaths and three overdoses) reported with use of codeine by FDA from 1969 through May 2012 (39). Ultra rapid metabolizers (UMs) have multiple copies of normally active CYP2D6 alleles, which greatly enhance codeine metabolism to morphine, increasing morphine toxicity related risks including respiratory depression and deaths (40). The risk unfortunately does not stop with codeine. There are reports of respiratory depression and death with other opioids (28). Our database review shows that other commonly used opioids may also be implicated in tonsillectomy related fatalities. Hence, it may be prudent to look beyond CYP2D6 ultra rapid metabolizers to identify other potential opioid interactions. In our institution, we have changed our practice of post-tonsillectomy pain management before the recent FDA s warning and further revised to

8 R. Subramanyam et al. Anesthesia and opioid related malpractice claims eliminate the use of codeine after the FDA s warning (11). Our current management includes maximizing analgesia with nonopioids administered on a scheduled basis (e.g., acetaminophen, ibuprofen, dexamethasone) and reserving the lowest effective dose of opioids not primarily dependent on CYP2D6 pathway such as morphine, hydromorphone, oxycodone on an as needed basis with appropriate safety instructions to parents (11,41). Further prospective research with alternative opioids and better clinical practices in children undergoing tonsillectomy are needed to make sure alternative opioids are safer than codeine. Our review also describes some of the other common and uncommon anesthesia complications for which claims are originated. The second common reason for claims after medications was difficult airway. Airway fires are reported as complications of tonsillectomy from use of higher inspired oxygen and uncuffed endotracheal tube allowing leak contributing to airway fire from electro-cautery. Tonsillectomy is regarded as a high-risk procedure for the occurrence of airway fires (42). There was an increase in the number of airway fires and oral burns compared to a previous publication with additional years of data (14). All the airway fires and most of the burns were associated with cautery. Avoiding use of 100% oxygen during airway surgery and minimizing leak around the breathing tube with a cuffed endotracheal tube might help reduce the risk of airway fire during tonsillectomy (42,43). Oxygen <40% in combination with air (nitrous oxide can in itself be combustible), spontaneous respiration or low peak inspiratory pressures, moist gauzes in the mouth or avoiding cautery when feasible would prevent airway fires. There are a few limitations to our study. LexisNexis is a nationwide database that has malpractice information submitted voluntarily. The case summary of some of the jury verdicts had insufficient information surrounding the events (e.g., the year of the verdict was available in 142 claims overall, age in 82 claims overall, cause of death in 74 of 98 deaths, and location of death in 34 of 98 deaths). The complications in such cases were categorized based on the definitions and a discussion with three reviewers of this database (RS, VC, SS). Though this is one of the largest claim studies following tonsillectomy, it shares the limitations of other claim studies such as limited clinical detail and lack of denominators for adverse events. The data for overall national incidence of the complications was not available along with some important demographic and outcome data. Presumably, not all complications are reported, and not all complications result in malpractice claims. It is assumed that the data reviewed is a representative sample of claims made nationally; however, it is possible that our data may not be inclusive of overall complications. Focus on jury verdicts leaves out the large number of malpractice cases that are settled outside the court. Jury awards by inherent nature are influenced by a large number of factors, including state limits and laws, nature of the jury, lawyers and the defendants, potential family and other circumstances that are allowed to influence the decision. There were cases with additional surgeries involved included in the final analysis when the claims were thought to originate from tonsillectomy and/or airway events or had insufficient information to exclude them. To conclude, from a medico legal perspective, anesthesia- and opioid-related complications after tonsillectomy resulted in death and major injury claims including anoxic brain injuries resulting in higher monetary awards than more frequent surgery-related claims. Monetary awards due to anesthesia and opioid related factors were especially higher for nonfatal injury claims than death claims. Acknowledgments No ethical approval needed. No financial support/conflicts of interests except departmental salary support for authors. Conflict of interest No conflicts of interest declared. Supporting information Additional Supporting Information may be found in the online version of this article: Table S1 Case descriptions examples of claims awarded monetary claims as described in the database. References 1 Cullen KA, Hall MJ, Golosinskiy A. Ambulatory surgery in the United States, Natl Health Stat Report 2009; 11: Rosenfeld RM, Green RP. Tonsillectomy and adenoidectomy: changing trends. Ann Otol Rhinol Laryngol 1990; 99: Erickson BK, Larson DR, St Sauver JL et al. Changes in incidence and indications of tonsillectomy and adenotonsillectomy, Otolaryngol Head Neck Surg 2009; 140: Marcus CL, Moore RH, Rosen CL et al. The Childhood Adenotonsillectomy Trial (CHAT). A Randomized Trial of 419

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