Linda S. Stephens

Postoperative opioid-induced respiratory depression: a closed claims analysis.

Background:Postoperative opioid-induced respiratory depression (RD) is a significant cause of death and brain damage in the perioperative period. The authors examined anesthesia closed malpractice claims associated with RD to determine whether patterns of injuries could guide preventative strategies. Methods:From the Anesthesia Closed Claims Project database of 9,799 claims, three authors reviewed 357 acute pain claims that occurred between 1990 and 2009 for the likelihood of RD using literature-based criteria. Previously cited patient risk factors for RD, clinical management, nursing assessments, and timing of events were abstracted from claim narratives to identify recurrent patterns. Results:RD was judged as possible, probable, or definite in 92 claims (&kgr; = 0.690) of which 77% resulted in severe brain damage or death. The vast majority of RD events (88%) occurred within 24 h of surgery, and 97% were judged as preventable with better monitoring and response. Contributing and potentially actionable factors included multiple prescribers (33%), concurrent administration of nonopioid sedating medications (34%), and inadequate nursing assessments or response (31%). The time between the last nursing check and the discovery of a patient with RD was within 2 h in 42% and within 15 min in 16% of claims. Somnolence was noted in 62% of patients before the event. Conclusions:This claims review supports a growing consensus that opioid-related adverse events are multifactorial and potentially preventable with improvements in assessment of sedation level, monitoring of oxygenation and ventilation, and early response and intervention, particularly within the first 24 h postoperatively.

Malpractice Claims Associated with Medication Management for Chronic Pain

Background:Medication management is an integral part of chronic pain management. Prompted by an increase in the role of medication management in anesthesia chronic pain liability, we investigated the characteristics of malpractice claims collected from 2005 to 2008. Methods:After Institutional Review Board approval, we compared medication management claims with other chronic pain claims from the American Society of Anesthesiologists Closed Claims Database of 8,954 claims. Claims for death underwent in-depth analysis. Results:Medication management represented 17% of 295 chronic non-cancer pain claims. Compared with other chronic pain claims, medication management patients tended to be younger men (P < 0.01) with back pain. Most patients were prescribed opioids (94%) and also additional psychoactive medications (58%). Eighty percent of patients had at least one factor commonly associated with medication misuse and 24% had ≥ 3 factors. Most claims (82%) involved patients who did not cooperate in their care (69%) or inappropriate medication management by physicians (59%). Death was the most common outcome in medication management claims (57% vs. 9% in other chronic pain claims, P < 0.01). Factors associated with death included long-acting opioids, additional psychoactive medications, and ≥ 3 factors commonly associated with medication misuse. Alleged addiction from prescribed opioids was the complaint in 24%. Appropriateness of care and payments was similar for medication management versus other chronic pain claims. Conclusions:Most anesthesia malpractice claims for medication management problems involved patients with a history of risk behaviors commonly associated with medication misuse. Malpractice claims arising from medication management had a high proportion of deaths with both patient and physician contributions to the outcome.

Massive hemorrhage: a report from the anesthesia closed claims project.

Background:Hemorrhage is a potentially preventable cause of adverse outcomes in surgical and obstetric patients. New understanding of the pathophysiology of hemorrhagic shock, including development of coagulopathy, has led to evolution of recommendations for treatment. However, no recent study has examined the legal outcomes of these claims. The authors reviewed closed anesthesia malpractice claims related to hemorrhage, seeking common factors to guide future management strategies. Methods:The authors analyzed 3,211 closed surgical or obstetric anesthesia malpractice claims from 1995 to 2011 in the Anesthesia Closed Claims Project. Claims where patient injury was attributed to hemorrhage were compared with all other surgical and obstetric claims. Risk factors for hemorrhage and coagulopathy, clinical factors, management, and communication issues were abstracted from claim narratives to identify recurrent patterns. Results:Hemorrhage occurred in 141 (4%) claims. Obstetrics accounted for 30% of hemorrhage claims compared with 13% of nonhemorrhage claims (P < 0.001); thoracic or lumbar spine surgery was similarly overrepresented (24 vs. 6%, P < 0.001). Mortality was higher in hemorrhage than nonhemorrhage claims (77 vs. 27%, P < 0.001), and anesthesia care was more often judged to be less than appropriate (55 vs. 38%, P < 0.001). Median payments were higher in hemorrhage versus nonhemorrhage claims (

Injury and Liability Associated with Implantable Devices for Chronic Pain

607,750 vs.

Trends in Pain Medicine Liability.

276,000, P < 0.001). Risk factors for hemorrhage and coagulopathy were common, and initiation of transfusion therapy was commonly delayed. Conclusions:Hemorrhage is a rare, but serious, cause of anesthesia malpractice claims. Understanding which patients are at risk can aid in patient referral decisions, design of institutional systems for responding to hemorrhage, and education of surgeons, obstetricians, and anesthesiologists.

Similar Liability for Trauma and Nontrauma Surgical Anesthesia: A Closed Claims Analysis

Background:Due to an increase in implantable device–related anesthesia pain medicine claims, the authors investigated anesthesia liability associated with these devices. Methods:After institutional review board approval, the authors identified 148 pain medicine device claims from 1990 or later in the Anesthesia Closed Claims Project Database. Device-related damaging events included medication administration events, infections, hematomas, retained catheter fragments, cerebrospinal fluid leaks, cord or cauda equina trauma, device placed at wrong level, stimulator incorrectly programmed, delay in recognition of granuloma formation, and other issues. Results:The most common devices were implantable drug delivery systems (IDDS; 64%) and spinal cord stimulators (29%). Device-related care consisted of surgical device procedures (n = 107) and IDDS maintenance (n = 41). Severity of injury was greater in IDDS maintenance claims (56% death or severe permanent injury) than in surgical device procedures (26%, P < 0.001). Death and brain damage in IDDS maintenance claims resulted from medication administration errors (n = 13; 32%); spinal cord injury resulted from delayed recognition of granuloma formation (n = 9; 22%). The most common damaging events for surgical device procedures were infections, inadequate pain relief, cord trauma, retained catheter fragments, and subcutaneous hygroma. Care was more commonly assessed as less than appropriate (78%) and payments more common (63%) in IDDS maintenance than in surgical device procedure claims (P < 0.001). Conclusions:Half of IDDS maintenance claims were associated with death or permanent severe injury, most commonly from medication errors or failure to recognize progressive neurologic deterioration. Practitioners implanting or managing devices for chronic pain should exercise caution in these areas to minimize patient harm.

What Adverse Events and Injuries Are Cited in Anesthesia Malpractice Claims for Nonspine Orthopaedic Surgery

Background: The authors examined changes in the frequency of pain medicine malpractice claims and associated treatment modalities and outcomes over time. Methods: The authors analyzed trends in pain medicine claims from 1980 to 2012 in the Anesthesia Closed Claims Project database by binary logistic regression on year of event. Pain procedures in claims from 2000 to 2012 were compared with the proportion of pain procedures reported to the National Anesthesia Clinical Outcomes Registry in 2010–2014. Results: Malpractice claims for pain medicine increased from 3% of 2,966 total malpractice claims in the Anesthesia Closed Claims Project database in 1980–1989 to 18% of 2,743 anesthesia claims in 2000–2012 (odds ratio [OR], 1.088 per year; 95% CI, 1.078 to 1.098; P < 0.001). Outcomes in pain claims became more severe over time, with increases in death and permanent disabling injury (OR, 1.094 per year; P < 0.001). Nonneurolytic cervical injections increased to 27% of pain claims in 2000–2012 (OR, 1.054; P < 0.001), whereas National Anesthesia Clinical Outcomes Registry demonstrates that lumbar injections are a more common procedure. Claims associated with medication management increased to 17% of pain claims in 2000–2012 (OR, 1.116 per year; P < 0.001). Conclusions: Pain medicine claims have increased over time and have increased in severity. Claims related to cervical procedures were out of proportion to the frequency with which they are performed. These liability findings suggest that pain specialists should aggressively continue the search for safer and more effective therapies.

Obstetric Anesthesia Liability Concerns

BACKGROUND:Trauma care has many challenges, including the perception by nonanesthesia physicians of increased medical malpractice liability. We used the American Society of Anesthesiologists’ Closed Claims Project database and the National Inpatient Sample (NIS) to compare the rate of claims for trauma anesthesia care to national trauma surgery data. We also used the American Society of Anesthesiologists’ Closed Claims Project database to evaluate injury and liability profiles of trauma anesthesia malpractice claims compared to nontrauma surgical anesthesia claims. METHODS:Surgical anesthesia claims for injuries that occurred between 1980 and 2005 in the American Society of Anesthesiologists’ Closed Claims Project database of 8954 claims were included in this analysis. Trauma was defined using cause of injury criteria in state trauma registries, including out-of-hospital falls. To estimate national trauma anesthesia rates, we used injury codes in NIS reports to define trauma discharges and NIS discharges with surgical procedure codes for the denominator. The year-adjusted odds ratio and P value comparing the national trauma anesthesia injury rates and American Society of Anesthesiologists’ Closed Claims Project inpatient claim rates in the 1990 to 2001 time period were calculated by a multivariate logistic regression of the injury/trauma outcome on year and the NIS/Closed Claims Project indicator. Payments in claim resolution between trauma claims and nontraumatic surgical anesthesia claims were compared by &khgr;2 analysis, Fisher exact test for proportions, and Kolmogorov–Smirnov test for payment amounts. RESULTS:Trauma claims represented 6% of the total 6215 surgical anesthesia claims in the study period. The inpatient trauma claims rates were consistently lower than the NIS injury rates for 1990 to 2001. The year-adjusted odds ratio comparing the trauma claims rates to the NIS injury rates was 0.62 (95% confidence interval [CI], 0.53 to 0.72; P < 0.001, likelihood ratio test). Trauma claims and nontrauma surgical anesthesia claims did not differ in appropriateness of care, whether or not a payment was made to the plaintiff, or size of payments. CONCLUSION:Despite reported perceptions that trauma care involves a high risk of medical liability, there was no apparent increased risk of liability among inpatients presenting for trauma anesthesia care. The proportion in malpractice claims in trauma anesthesia care was not increased compared to nontraumatic surgical anesthesia care. With respect to medicolegal liability, these results support participation of anesthesia providers in multidisciplinary trauma care and organized systems.

Postoperative Opioid-induced Respiratory Depression: A Closed Claims Analysis

BackgroundMalpractice claims that arise during the perioperative care of patients receiving orthopaedic procedures will frequently involve both orthopaedic surgeons and anesthesiologists. The Anesthesia Closed Claims database contains anesthesia malpractice claim data that can be used to investigate patient safety events arising during the care of orthopaedic patients and can provide insight into the medicolegal liability shared by the two specialties.Questions/Purposes(1) How do orthopaedic anesthetic malpractice claims differ from other anesthesia claims with regard to patient and case characteristics, common events and injuries, and liability profile? (2) What are the characteristics of patients who had neuraxial hematomas after spinal and epidural anesthesia for orthopaedic procedures? (3) What are the characteristics of patients who had orthopaedic anesthesia malpractice claims for central ischemic neurologic injury occurring during shoulder surgery in the beach chair position? (4) What are the characteristics of patients who had malpractice claims for respiratory depression and respiratory arrests in the postoperative period?MethodsThe Anesthesia Closed Claims Project database was the source of data for this study. This national database derives data from a panel of liability companies (national and regional) and includes closed malpractice claims against anesthesiologists representing > 30% of practicing anesthesiologists in the United States from all types of practice settings (hospital, surgery centers, and offices). Claims for damage to teeth or dentures are not included in the database. Patient characteristics, type of anesthesia, damaging events, outcomes, and liability characteristics of anesthesia malpractice claims for events occurring in the years 2000 to 2013 related to nonspine orthopaedic surgery (n = 475) were compared with claims related to other procedures (n = 1592) with p < 0.05 as the criterion for statistical significance and two-tailed tests. Odds ratios and their 95% confidence intervals were calculated for all comparisons. Three types of claims involving high-impact injuries in patients undergoing nonspine orthopaedic surgery were identified through database query for in-depth descriptive review: neuraxial hematoma (n = 10), central ischemic neurologic injury in the beach chair position (n = 9), and injuries caused by postoperative respiratory depression (n = 23).ResultsNonspine orthopaedic anesthesia malpractice claims were more frequently associated with nerve injuries (125 of 475 [26%], odds ratio [OR] 2.12 [1.66–2.71]) and events arising from the use of regional anesthesia (125 of 475 [26%], OR 6.18 (4.59–8.32) than in malpractice claims in other areas of anesthesia malpractice (230 of 1592 [14%] and 87 of 1592 [6%], respectively, p < 0.001 for both comparisons). Ninety percent (nine of 10) of patients with claims for neuraxial hematomas were receiving anticoagulant medication and all had severe long-term injuries, most with a history of significant delay in diagnosis and treatment after first appearance of signs and symptoms. Central ischemic injuries occurring during orthopaedic surgery in the beach chair position did not occur solely in patients who would have been considered at high risk for ischemic stroke. Patients with malpractice claims for injuries resulting from postoperative respiratory depression events had undergone lower extremity procedures (20 of 23 [87%]) and most events (22 of 23 [96%]) occurred on the day of surgery or the first postoperative day.ConclusionsNonspine orthopaedic anesthesia malpractice claims more frequently cited nerve injury and events arising from the use of regional anesthesia than other surgical anesthesia malpractice claims. This may reflect the frequency of regional anesthesia in orthopaedic cases rather than increased risk of injury associated with regional techniques. When neuraxial procedures and anticoagulation regimens are used concurrently, care pathways should emphasize clear lines of responsibility for coordination of care and early investigation of any unusual neurologic findings that might indicate neuraxial hematoma. We do not have a good understanding of the factors that render some patients vulnerable to the rare occurrence of intraoperative central ischemic injury in the beach chair position, but providers should carefully calculate cerebral perfusion pressure relative to measured blood pressure for patients in the upright position. Postoperative use of multiple opioids by different concurrent modes of administration warrant special precautions with consideration given to the provision of care in settings with enhanced respiratory monitoring. The limitations of retrospective closed claims database review prevent conclusions regarding causation. Nonetheless, the collection of relatively rare events with substantial clinical detail provides valuable data to generate hypotheses about causation with potential for future study to improve patient safety.Level of EvidenceLevel III, therapeutic study.

The American College of Surgeons’ Closed Claims Study: New Insights for Improving Care

Obstetric practice carries a high risk of medical liability and involves both obstetricians and anesthesiologists. Analysis of data from the Anesthesia Closed Claims Project database shows an increase in the proportion of anesthesia claims for maternal death and brain damage between the 1990s and 2000 and later, primarily due to hemorrhage. The proportion of claims for newborn brain damage remained unchanged while those for maternal nerve injury and minor injuries decreased. Use of massive transfusion protocols and clinical drills have been shown to improve outcomes from hemorrhage. Good communication and teamwork are critical for reducing obstetric liability.