Overview of Obstetric Anesthesia Professional Liability
WHEC Practice Bulletin and Clinical Management Guidelines for healthcare providers. Educational grant provided by Women's Health and Education Center (WHEC).
Obstetrics carries high medical liability risk. Maternal death and newborn death or brain damage are the most common claims. The 2006 American College of Obstetricians and Gynecologists (ACOG) survey on professional liability showed that 89% of respondents had been sued during their careers, with an average of 2.6 claims per obstetrician. The majority of claims were related to newborn injury, with 31% associated with newborn brain injury and 16% related to stillbirth or neonatal death. Nearly 39% of specialists in obstetrics and gynecology had a professional liability payment made on their behalf between 1996 and 2005 (1). Nearly in two decades, a review of liability associated with obstetric anesthesia using the American Society of Anesthesiologists (ASA) Closed Claim database found that, although awards to plaintiffs were higher in obstetric claims from the 1970s and 1980s, there were more claims for minor complications in obstetric compared to non-obstetric claims. The most common complications in obstetric claims were newborn death or brain damage (29%) and maternal death (22%). Over the past three decades, there have been numerous changes in the practice of anesthesiology in general and in the practice of obstetric anesthesia specifically. The use of general anesthesia, particularly for elective cesarean sections has decreased, and the use of epidural anesthesia for labor analgesia has increased. In addition, there has been increasing recognition that only a minority of cases of newborn encephalopathy are related to intrapartum hypoxia, most of which are not preventable by actions of care-givers.
The purpose of this document is to review liability profile changes over the past two decades. Specifically explored are the contribution of newborn death and brain damage compared to maternal death and brain damage to obstetric anesthesia liability in 1990 or later claims. This review should spur us to examine and change our practices to minimize both patient harm and our liability when we are not at fault. Only closed claim analyses can help us understand the conditions under which fatal and non-fatal injuries lead to litigation.
Overview of Injuries and Liability:
Newborn death or brain damage has decreased, yet it remains a leading cause of obstetric anesthesia malpractice claims over time. Potentially preventable anesthetic causes of newborn injury included delays in anesthesia care and poor communication between obstetrician and anesthesiologist. The ASA Closed Claims Project is a structured evaluation of adverse anesthetic outcomes obtained from the closed claim files of 35 United States professional liability insurance companies. Claims for dental damage are not included in this database. The damaging event that causes the injury is determined by the on-site anesthesiologist reviewer and gets confirmed by the Closed Claim Committee. For the purposes of analysis, injuries are grouped into temporary / non-disabling (score = 0-5) versus permanent / disabling (score = 6-8) versus death (score = 9). Appropriateness of anesthesia care is rated as appropriate (standard), sub-standard, or impossible to judge on the basis of reasonable or prudent practice at the time of the event by the on-site reviewer. A previously published study found reliability of reviewer judgments to be acceptable (2).
In a large study the most common injuries leading to obstetric claims are newborn death or brain damage (21%) and maternal nerve injury (21%). Claims for maternal minor injuries (eg, headache, back pain, pain during surgery, and emotional distress) made up a large proportion (28%) of obstetric claims (3). The claims for maternal death / brain damage resulted in a higher frequency of payments on behalf of anesthesiologists reflect an increased likelihood of an anesthesia contribution to the maternal injury compared to newborn injury. In addition, it reflects ASA policy that the anesthesiologist is primarily responsible for the mother and that personnel other than the surgical team should assume responsibility for resuscitation of the depressed newborn. Payments made on behalf of anesthesiologists for maternal death / brain damage is also associated with the judgment of substandard anesthesia care; however, outcome bias may have confounded this judgment (2),(3).
Maternal Deaths and Brain Damage:
The most common anesthetic causes of maternal death or permanent brain damage in the claims included difficult intubation, maternal hemorrhage, and high neuraxial block, consistent with anesthetic causes of death in published reports (4). Inability to reverse the effects of severe maternal disease (massive hemorrhage, embolism, preeclampsia, hypertensive intracranial hemorrhage, and chorioamnionitis) led to 39% of the maternal deaths and / or permanent brain damage lawsuits. The maternal death, and the litigation, in these situations most probably could not have been avoided, one must be prepared to identify high-risk patients and treat these diseases. The most common anesthetic causes of maternal death / brain damage in claims associated with general anesthesia in the reports are related to difficult intubation and maternal hemorrhage. These claims involved multiple intubation attempts leading to progressive difficulty with ventilation. Maternal hemorrhage has been associated with an inability of the anesthesiologist to keep up with blood loss despite best efforts in these reports (n = 10) and with inadequate fluid replacement in which it should have been possible to resuscitate during surgical bleeding (n = 1). Causes of maternal hemorrhage included subcapsular hepatic bleeding in a preeclampsia patient, placenta previa (n = 2), placenta accrete / placenta percreta (n = 2), and uterine rupture (n = 1).
The most common anesthetic cause of maternal death / brain damage in regional anesthesia claims were due to high neuraxial block (n = 15). There were no claims related to intravascular injection of local anesthetics, consistent with changes in clinical practice in the mid-1980s with the withdrawal of 0.75% bupivacaine in obstetrics and increased use of test doses and fractionated administration of local anesthetics (5). The use of a test dose and incremental dosing of epidural catheters is recommended for early detection of accidental intrathecal injection and prevention of high neuraxial block. However, delays in recognizing the treating cardio-respiratory collapse secondary to a high block as well as inadequate resuscitation equipment continue to result in maternal injury. Even more cautions incremental dosing of epidurals may aid in early detection of an accidental intrathecal injection and prevent a high block. In the event of a high neuraxial block, all staff should be familiar with the location of the code cart equipped with appropriated equipment and drugs. All epidural carts should include airway equipment and emergency drugs to allow for immediate resuscitation.
Newborn Death and Brain Damage:
Anesthesiologist exposure to newborn injury claims may occur because the anesthesiologist serves as a "deep pocket" (especially in the case of an underinsured obstetrician). Although anesthesiologists may be named on a lawsuit, the study found that anesthesiologist liability (eg, payments) for newborn death / brain damage was limited, most likely because the obstetrician is primarily responsible for fetal well being. Obstetric, not anesthetic, causes are more common for peripartum hypoxic brain injury (6). Therefore working with obstetricians to decrease the incidence of this newborn death and brain damage is probably the best way to reduce anesthesiologist's liability. The study found that anesthetic events were rare; other than an intraoperative catastrophe (eg, difficult intubation, high block, severe hypotension); more than half of anesthesia-related events involved an anesthesia delay that resulted from anesthesia technique. A decision to start of cesarean delivery interval for emergency cesarean section within 30 minutes is the international standard for fetal compromise (7). Although the scientific evidence to support the standard is weak, failure to meet this target time may be part of the judgment of the substantial care. The anesthesia team should therefore ensure that the patient is ready for surgical incision within 30 minutes of the decision for cesarean section; if exceeded, thorough documentation of the reason for delay in the medical record is essential.
Newborn outcome may be improved by better communication between obstetrician and anesthesiologist, particularly concerning the urgency of cesarean section. In many reviews, more than a third of anesthesia-related newborn death and brain damage had poor communication between the obstetrician and anesthesiologist. In a 2004 Joint Commission Sentinel Event Alert (8), the leading preventable cause of neonatal death and brain damage in 47 cases was miscommunication between care providers. In many practices, anesthesiologists are on call for obstetrics from home. This practice may be acceptable in low-risk cases; however, in high-risk patients (eg, patients desiring vaginal birth after cesarean section who are at higher risk of uterine rupture), a delay in time to get to the hospital can prove fatal to both mother and baby. Failure to communicate the urgency of a cesarean section may compound this issue and result in an inappropriate choice of anesthesia technique. Emphasis on improved communication between all providers caring for individual patients, especially those at high risk, may therefore help avoid poor outcomes.
Maternal Nerve Injury:
The nerve injury is the most common injury associated with obstetrical anesthesia claims reflects the increased liability for nerve injury with regional anesthesia. Although a regional block may have caused the nerve injury in nearly two thirds of the nerve injury claims in most of the studies, nerve injury resulting from obstetric causes (eg, pregnancy, vaginal delivery, fetal position, maternal position during second stage of labor) is more likely than nerve injury resulting from regional anesthesia (9). A good knowledge of neuro-anatomy together with specialist neurologic examination and appropriate investigation, such as electromyography, can aid in the accurate diagnosis of nerve injuries. Serious disabling spinal cord injuries resulting in paraplegia were noted in 11% of nerve injury claims, with causes consistent with those described in the literature. Nerve injury (n = 89) was the leading maternal injury in obstetric claims from 1990 or later, most of which was temporary or non-disabling (80%). All but one nerve injury was associated with regional anesthesia, and nerve injury was more commonly associated with vaginal delivery than with the cesarean section (10). Most cases of nerve injury (63%) could have been caused by the administration of regional anesthesia as evaluated by the on-site anesthesiologist reviewer, but no specific event leading to nerve injury could be identified in 18 claims (20%), in this study, and 12 (13%) were related to patient condition or delivery. Radiculopathy of a lumbar or sacral root accounted for the majority of injuries. Spinal cord injury resulted in paraplegia in 10 nerve injury claims (11%). When known, the etiology for spinal cord injuries was epidural hematoma (n = 4, only 1 of which had a coagulopathy), epidural abscess (n = 4), direct injection into the cord (n = 2), and anterior spinal artery syndrome (n = 1). The majority of nerve injury claims were judged to have received appropriate care, and payment was made by the anesthesia providers in less than one third of claims for nerve injury (10).
Trends in Obstetric Anesthesia Professional Liability:
Analysis of data collected from the ASA Closed Claims project (10) has a number of limitations. The database does not contain claims on all adverse anesthetic events, and it lacks denominator data on the number of anesthetic performed annually. The finding of a decrease in proportion of claims for maternal death and increase in the proportion of nerve injury in the 1990 or later claims compared to earlier claims may reflect changes in anesthesia practice specifically over the last three decades (7), (8), (9). The surveys have shown a steady decrease in use of general anesthesia for elective sections, along with an increase in use of epidural anesthesia for labor analgesia. In addition, the decrease in the proportion of claims for maternal death mirrors those in the closed claims database at large and it may reflect changes in drugs, training, an emphasis on safety, changes in legal strategies, or other events. Decreases in respiratory events in the 1990 or later obstetric claims are probably associated with the use of respiratory system monitors in modern anesthesia practice, the decrease in the use of general anesthesia in obstetric practice, and the enhanced awareness of the risk of aspiration of gastric contents in the obstetric patient. Although claims for newborn death and brain damage still remain a frequent (21%) claim against anesthesiologists, the reduction in these claims over time is probably related to the recognition beginning in the mid-1980s that most cases of newborn brain injury are not related to birth asphyxia (1), (2). Current evidence suggests most cases of newborn brain damage are due to antenatal factor, and only a minority are related to intrapartum hypoxia, most of which are not preventable. Increasing public awareness of these antenatal factors may further reduce anesthesiologists' liability for these claims in the future.
The Closed Claim Project (11) staff have analyzed available obstetric anesthesia malpractice claims from 1990 to 2003 (n = 426) and compared these claims to pre-1990 obstetric claims (n = 190). In both time periods, obstetric claims constituted 12-13% of all perioperative claims. The cesarean delivery rate in the United States has increased since 1990; however, when compared to pre-1990 claims, a smaller fraction of recent claims involve cesarean delivery (58% vs. 67%). Compared to pre-1990 claims, maternal and neonatal death / brain damage decreased and maternal nerve injury increased in frequency. Anesthesia delay was alleged in 11 cases of neonatal death / brain damage. The time of the delay averaged 40 ± 22 minute (range, 10 -- 70 minutes). Inability to reverse the effects of severe maternal disease (massive hemorrhage, embolism, preeclampsia, hypertensive intracranial hemorrhage, and chorioamnionitis) led to 39% (27 of 69) of the maternal death / permanent brain damage lawsuits. The proportion of claims with substandard care decreased (22% vs. 39%), payment was made less frequently (42% vs. 58%), and median payment decreased ($222,000 vs. $455,000). All the cases of difficult intubation (n = 7) occurred before 1999 in many studies.
It appears that modern emergency airway equipment and the use of the difficult airway algorithm have improved obstetric anesthesia care. Vaginal delivery in many studies was associated with many more lawsuits than cesarean delivery, 80% of the injuries were temporary or non-disabling, and 19% involved femoral or sciatic nerve injury. Proper in-hospital evaluation of these injuries might have aided the defense against unwarranted litigation.
There are many important lessons can be learned from this analysis. Communication counts. More than one third of anesthesia-related cases of newborn death / brain damage involve poor communication between the obstetricians and anesthesiologists. While the obstetrician may have communicated poorly, the anesthesiologist also gets sued for the subsequent delay. Poor communication among obstetricians, anesthesia providers, labor floor nurses, pediatricians, and hospital blood banks is unfortunately common and can lead to patient harm. Neatness and completeness count. Illegible, inaccurate and incomplete records and poor English skills lead to payouts in cases in which there is no possibility of an anesthesia contribution to the injury. Clearly, the 30-minute rule did not prevent litigation in several of these cases (1), (2), (11). Factors associated with anesthesia delay included inappropriately prolonged attempts to establish regional anesthesia and the anesthesiologist not being in the hospital. Anesthesiologists who take obstetric calls from home may want to reassess the safeguards they have instituted to prevent anesthesia delay of emergency cesarean delivery. Although it is likely that the maternal death, and the litigation, could not have been avoided in inability to reverse the effects of severe maternal disease (maternal hemorrhage, embolism, preeclampsia, hypertensive intracranial hemorrhage, and chorioamnionitis), one must be prepared to treat these diseases. High risk patients should have anesthesia consultation during pregnancy or pre-operatively. Medical intervention undoubtedly saves many lives. Concerns about a possible increase in anesthetic maternal mortality must be kept in perspective with the overall benefits. The growing complexity of problems such as maternal disease, obesity, and the increasing age of motherhood, nevertheless, increases the challenges presented (10). Multidisciplinary working is all-important.
Amniotic fluid embolism is the second leading direct cause of maternal death in the United States, contributing 17% of the direct maternal deaths in a recent population-based survey (1), (2). Although amniotic fluid embolism is rare, most mothers still die. Anesthesiologists as well as obstetricians are frequently sued in these cases, though there were only 4 such cases in the current closed claim analysis. We should join in looking for ways to decrease mortality after amniotic fluid embolism. Nerve damage is one of the maternal injuries leading to the large number of lawsuits. It is likely that many of the nerve injuries could be actually obstetric nerve injuries. If a postpartum patient has a substantial nerve injury, it is important to have an otherwise uninvolved physician perform and document a thorough neurologic exam. Injuries with dermatomal distributions are more likely to be anesthesia-related, and injuries in the distributions of peripheral nerves are more likely to be obstetric nerve palsies. Recovery from these nerve injuries can take months (9). Whatever the cause of the injury, appropriate referrals should be made for physical rehabilitation and supportive devices if needed. To avoid spinal cord injuries during regional block, switching to an alcohol-based preparation solution may decrease the frequency of epidural abscess. To avoid intraneural injection, it is important to never inject in the presence of a paresthesia and to avoid needle insertion at upper lumbar interspaces. Anesthesia providers should always be adequately prepared to treat hypotension or an airway emergency when placing epidurals in the labor and delivery rooms. Failure to detect high spinal can cause serious patient harm. Use of a lidocaine-epinephrine test dose and detection by aspiration are helpful to avoid high spinal, the aspiration syndrome and hypotension.
Due to the large number variables examined in various studies, false positive findings may result. Other limitations include only modest inter-observer agreement regarding appropriateness of care. Although the long statute of limitations for newborn injury may result in incomplete claims data for newborn brain damage, the year of injury is similar in maternal and newborn claims in many studies. Despite these deficiencies in ASA Closed Claims Database, it provides useful information on large numbers of rare adverse events and snapshot of liability in the practice of anesthesiology. Closed claim analyses supplement but do not replace population-based surveys of the causes of maternal mortality. Incidence information can only be obtained from population-based surveys. However, only closed claim analyses can help us understand the conditions under which fatal and non-fatal injuries lead to litigation. Both closed claim analyses and population-based surveys are needed to optimize the care of the obstetric patient. Delays in diagnosis and resuscitation of high neuraxial block are preventable causes of maternal death / brain damage.
We thank Dr. Bhavani Shankar Kodali, Associate Professor, Harvard Medical School, Attending Anesthesiologist at Brigham and Women's Hospital, Boston, MA (USA) for the assistance in preparing the review and bulletin.