Pediatric Anesthesia ISSN 1155-5645
ORIGINAL ARTICLE
Anesthesia- and opioids-related malpractice claims following tonsillectomy in USA: LexisNexis claims database 1984–2012 Rajeev Subramanyam1, Vidya Chidambaran1, Lili Ding2, Charles M. Myer III3 & Senthilkumar Sadhasivam1 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 Email: [email protected] Section Editor: Jerrold Lerman Accepted 29 November 2013 doi:10.1111/pan.12342 This was presented as an abstract at Society of Pediatric Anesthesia Meeting at Las Vegas, 2013. The abstract was selected as the first prizewinner of the American Academy of Pediatrics John J. Downes Resident Research Award.
412
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 MEGATM 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 ($1 625 892) and nonfatal injury ($3 484 278) 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.
© 2014 John Wiley & Sons Ltd Pediatric Anesthesia 24 (2014) 412–420
R. Subramanyam et al.
Introduction Tonsillectomy is a very commonly performed ambulatory procedure in the United States with about 737 000 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/ 10 000 (1 in 16 000) to 0.29/10 000 (1 in 35 000) based on data from the 1970s (17). A more recent European survey showed a post-tonsillectomy mortality rate of 0.62–0.63 per 10 000, 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 MEGATM 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 © 2014 John Wiley & Sons Ltd Pediatric Anesthesia 24 (2014) 412–420
Anesthesia and opioid related malpractice claims
no patient health information was reviewed. LexisNexis MEGATM Jury Verdicts and Settlements database (Dayton, OH, USA) was searched using MeSH terms ‘tonsillectomy’ and ‘malpractice’ between 1984 and 2012. 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
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Anesthesia and opioid related malpractice claims
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
Surgery related Anesthesia related Opioid related Uncategorized
Fatal injury claims n (%) 98 (40.5%)
Nonfatal injury claims n (%) 144 (59.5%)
39 (39.8%) 36 (36.7%) 16 (16.3%) 17 (17.4%)
101 (70.1%) 32 (22.2%) 6 (4.2%) 9 (6.3%)
Some claims had overlapping causes between the surgery-, anesthesia-, and opioid-related categories.
analyzed with descriptive statistics with number (n) and percentages (%) for categorical variables; and mean, median, and quantiles for continuous variables. Plaintiff (patient) characteristics The median age group of patients was 8.5 years 15.0 14.8 years; minimum age (Mean SD: 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.
414
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 © 2014 John Wiley & Sons Ltd Pediatric Anesthesia 24 (2014) 412–420
R. Subramanyam et al.
Anesthesia and opioid related malpractice claims
Table 2 Complications that were associated with malpractice claims
Main variable
Factors
Surgical
Bleeding Burn injury* Infection Medication Soft-tissue injury Others Airway or oral fire/burns* Adult respiratory distress syndrome Arrhythmias Aspiration Below standard of care Bronchospasm Cardiorespiratory failure/arrest Difficult airway Fluid overload Hypoxic brain damage** Inadequate anesthesia No consent Malignant hyperthermia (Halothane) Non opioid medications Negligent intraoperative monitoring Pulmonary edema Seizures Sepsis Soft tissue/bone/ teeth injury
Anesthesia
Opioids
Fatal injury claims (n = 98) n (%)
Nonfatal injury claims (n = 144) n (%)
23 (23.5) 0 0 7 (7.1) 0 10 (10.2) 0 1 (1)
18 (12.5) 19 (13.2) 3 (2.1) 3 (2.1) 30 (20.8) 13 (9.0) 7 (4.9) 0
0 4 (4) 1 (1) 1 (1) 1 (1)
1 (0.7) 2 (1.4) 0 1 (0.7) 1 (0.7)
5 (5.1) 1 (1) — 0 1 (1) 0
5 (3.5) 0 2 (1.3) 1 (0.7) 0 1 (0.7)
4 (4) 1 (1)
4 (2.1) 4 (2.1)
3 (3.1) 1 (1) 1 (1) 0
0 0 0 4 (2.1)
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 © 2014 John Wiley & Sons Ltd Pediatric Anesthesia 24 (2014) 412–420
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 ($1 625 892) and nonfatal injury ($3 484 278) claims. Similar to opioid-related awards, median monetary awards for anesthesia-related nonfatal injuries ($582 751) were higher than anesthesia-related fatal injuries (341 236) (Table 5). The monetary awards of more than $ 1 000 000 (2013 inflation adjusted US $) related to opioids occurred in children
ORIGINAL ARTICLE
Anesthesia- and opioids-related malpractice claims following tonsillectomy in USA: LexisNexis claims database 1984–2012 Rajeev Subramanyam1, Vidya Chidambaran1, Lili Ding2, Charles M. Myer III3 & Senthilkumar Sadhasivam1 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 Email: [email protected] Section Editor: Jerrold Lerman Accepted 29 November 2013 doi:10.1111/pan.12342 This was presented as an abstract at Society of Pediatric Anesthesia Meeting at Las Vegas, 2013. The abstract was selected as the first prizewinner of the American Academy of Pediatrics John J. Downes Resident Research Award.
412
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 MEGATM 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 ($1 625 892) and nonfatal injury ($3 484 278) 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.
© 2014 John Wiley & Sons Ltd Pediatric Anesthesia 24 (2014) 412–420
R. Subramanyam et al.
Introduction Tonsillectomy is a very commonly performed ambulatory procedure in the United States with about 737 000 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/ 10 000 (1 in 16 000) to 0.29/10 000 (1 in 35 000) based on data from the 1970s (17). A more recent European survey showed a post-tonsillectomy mortality rate of 0.62–0.63 per 10 000, 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 MEGATM 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 © 2014 John Wiley & Sons Ltd Pediatric Anesthesia 24 (2014) 412–420
Anesthesia and opioid related malpractice claims
no patient health information was reviewed. LexisNexis MEGATM Jury Verdicts and Settlements database (Dayton, OH, USA) was searched using MeSH terms ‘tonsillectomy’ and ‘malpractice’ between 1984 and 2012. 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
R. Subramanyam et al.
Anesthesia and opioid related malpractice claims
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
Surgery related Anesthesia related Opioid related Uncategorized
Fatal injury claims n (%) 98 (40.5%)
Nonfatal injury claims n (%) 144 (59.5%)
39 (39.8%) 36 (36.7%) 16 (16.3%) 17 (17.4%)
101 (70.1%) 32 (22.2%) 6 (4.2%) 9 (6.3%)
Some claims had overlapping causes between the surgery-, anesthesia-, and opioid-related categories.
analyzed with descriptive statistics with number (n) and percentages (%) for categorical variables; and mean, median, and quantiles for continuous variables. Plaintiff (patient) characteristics The median age group of patients was 8.5 years 15.0 14.8 years; minimum age (Mean SD: 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.
414
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 © 2014 John Wiley & Sons Ltd Pediatric Anesthesia 24 (2014) 412–420
R. Subramanyam et al.
Anesthesia and opioid related malpractice claims
Table 2 Complications that were associated with malpractice claims
Main variable
Factors
Surgical
Bleeding Burn injury* Infection Medication Soft-tissue injury Others Airway or oral fire/burns* Adult respiratory distress syndrome Arrhythmias Aspiration Below standard of care Bronchospasm Cardiorespiratory failure/arrest Difficult airway Fluid overload Hypoxic brain damage** Inadequate anesthesia No consent Malignant hyperthermia (Halothane) Non opioid medications Negligent intraoperative monitoring Pulmonary edema Seizures Sepsis Soft tissue/bone/ teeth injury
Anesthesia
Opioids
Fatal injury claims (n = 98) n (%)
Nonfatal injury claims (n = 144) n (%)
23 (23.5) 0 0 7 (7.1) 0 10 (10.2) 0 1 (1)
18 (12.5) 19 (13.2) 3 (2.1) 3 (2.1) 30 (20.8) 13 (9.0) 7 (4.9) 0
0 4 (4) 1 (1) 1 (1) 1 (1)
1 (0.7) 2 (1.4) 0 1 (0.7) 1 (0.7)
5 (5.1) 1 (1) — 0 1 (1) 0
5 (3.5) 0 2 (1.3) 1 (0.7) 0 1 (0.7)
4 (4) 1 (1)
4 (2.1) 4 (2.1)
3 (3.1) 1 (1) 1 (1) 0
0 0 0 4 (2.1)
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 © 2014 John Wiley & Sons Ltd Pediatric Anesthesia 24 (2014) 412–420
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 ($1 625 892) and nonfatal injury ($3 484 278) claims. Similar to opioid-related awards, median monetary awards for anesthesia-related nonfatal injuries ($582 751) were higher than anesthesia-related fatal injuries (341 236) (Table 5). The monetary awards of more than $ 1 000 000 (2013 inflation adjusted US $) related to opioids occurred in children
