Malpractice Litigation Related to Endotracheal Intubation-Related Complications

Establishing an airway through intubation is a staple of anesthesiology, critical care, and emergency medicine(1) and also may be performed by other medical specialties. Although it is a common procedure, intubation is associated with inherent risks,(2) including tracheal perforation;(3,4) dental dislodging;(5) and cardiac arrest, brain damage, or death from hypoxia.(6,7) Non-anesthesiologist physicians are more than twice as likely to fail tracheal intubation as anesthesiologists in emergency situations.(8)

Anesthesiology has demonstrated itself to be a field with a focus on patient safety through analysis of medical errors,(9) although no studies to date have investigated complications of intubation as a procedure through malpractice cases across specialties. We sought to investigate the variables contributing to intubation-related lawsuits and the factors associated with litigation outcomes, including medical scenarios involved, details of injury, and practitioners responsible. We hypothesized that clinically relevant differences between specialties regarding allegation types and litigation outcomes would be observed.

Methods

Data Collection

Data for this study were generated using VerdictSearch (ALM Media Properties), an extensive online database providing comprehensive information on more than 200,000 trial outcomes across the United States. This database has been used in prior medical malpractice studies in the fields of neurosurgery and orthopedic surgery.(10-12) Cases were selected in which endotracheal intubation was a primary and fundamental component of the lawsuit.

Cases were divided into pediatric (i.e., patient under 18 years of age) and adult cases, with pediatric cases excluded from this investigation. Cases were sorted by medical outcome including death, sequelae of neurological injury (anoxic/hypoxic brain injury, sustained cognitive impairment, paralysis), and non-neurological injury (physical damage from intubation process).

All malpractice lawsuit cases were categorized based on the nature of the alleged physician error. “Delay in intubation or reintubation” cases alleged caregiver delay in choosing to intubate, including cases where bilevel positive airway pressure (BiPAP) or a laryngeal mask airway (LMA) was used in the interim. “Technical failure in intubation or reintubation” included cases of esophageal intubation, right mainstem bronchus intubation, or failure to use a tube exchanger when it was deemed standard of care. “Failure to monitor” cases included failure to notice extubation, esophageal intubation, bronchospasm, or tube malposition in a timely manner. “Inadvertent extubation” cases included failure to secure the endotracheal tube or sedate the patient adequately. In “failure to ensure working equipment” cases, the presence or functionality of anesthesia equipment was not confirmed. Tooth dislodgement and temporomandibular joint (TMJ) injuries were included in the category “tooth dislodgement/jaw injury (dental),” while other injuries were categorized as “other mechanical injury (non-dental),” which included vocal cord or nerve damage, pharyngeal soft tissue damage, disc herniation, vertebral artery damage, injury from neck hyperextension, tracheal tear, tonsil or soft palate laceration, subglottic stenosis, or gastrointestinal (GI) tract damage. Cases involving “inappropriate sedation drugs/plan” involve what was deemed excessive sedation during the process of securing a difficult airway and/or failure to paralyze when it was deemed the standard of care. Other categories included “extubating before appropriate,” “delay or improper tracheotomy technique,” “intubating when inappropriate due to foreign body presence,” “failure to ventilate with an LMA before reintubating,” and “failure to take appropriate aspiration precautions.”

Further relevant case information also was recorded, including plaintiff age and gender, types of defendants, outcomes, and payment amounts. Outcomes generally were categorized as plaintiff verdicts, defense verdicts, or settlements outside of court, although some cases were instead categorized, using the VerdictSearch criteria, as mixed juries or arbitration with payouts. The category plaintiff verdicts indicate cases in which the physician was found guilty of malpractice, whereas cases concluding in defense verdicts found the physician not guilty of medical malpractice and resulted in no payment. The category settlements suggests agreement between the physician and plaintiff party resulting in physician payment without a trial verdict. Mixed verdicts, categorized separately in the VerdictSearch database, suggest a verdict against the physician differing from the full allegations originally brought forward. Arbitration cases indicate a binding verdict made outside the court by an external third party, and often resulted in physician payment (Figure 1).

Figure 1. Case selection process.

All data were entered into Microsoft Excel 2010, and percentages were calculated for all relevant categories. The monetary amounts for plaintiff and mixed verdict payouts, settlements, and arbitration sums were also computed using Excel software.

Results

Case Characteristics

Table 1 presents case characteristics for lawsuits concerning intubation malpractice.

Our retrospective analysis of the 22,566 medical malpractice cases available in VerdictSearch involved manually searching the data for “intubation,” which yielded 425 results between December 1987 and December 2017 (30 years). Of these identified cases, only lawsuits against physicians or hospitals representing physicians were included, and all pediatric cases were excluded. This left us with 181 cases with a total of 212 lawsuits against physicians in which complications related to intubation were the primary reason for litigation. The mean age of identified plaintiffs was 49.7 ± 15.4 years. Only 1.8% of case records (n=4) did not list patient age. Twenty states were represented, with New York (21%, 38 cases) and California (17%, 30 cases) the most represented.

Delay in choosing to intubate or reintubate a patient, including cases where BiPAP or an LMA was chosen in the interim, was the most common reason for litigation overall (24%, 51 cases). Mechanical injury during intubation accounted for 32% (47) of cases, the vast majority of which were non–tooth or jaw injuries (17% of total, 37 cases): vocal cord or nerve damage represented the largest percentage of these injuries (29.0%), followed by gastrointestinal tract damage (22.6%) and pharyngeal soft tissue damage (22.6%). Other injury types included disc herniation and subsequent paralysis, vertebral artery damage, tracheal tear, and subglottic stenosis. Technical failure during intubation or reintubation was the cause of litigation in 15% (32) of cases (Table 1). More than one allegation category applied in 12.2% of cases (n=22).

Lawsuit Outcomes

The trial ended in favor of the plaintiff (patient or estate) in 22% of cases (n=39), whereas a defendant verdict was rendered in 44% (n=80). A settlement was reached outside of court in 28% of lawsuits (n=51). Six percent of lawsuits (n=11) ended in either arbitration (i.e., case concluded by an external party) or mixed verdicts (i.e., final charges differing from the full initial allegations), with all but two awarding payment to the plaintiff. The average plaintiff verdict award was $7,151,327 ± $18,420,717. The average settlement payment was $1,898,145 ± $4,910,054, with one settlement payout was listed as confidential. The average mixed verdict award was $5,511,071 ± $9,297,926, and the average arbitration award was $179,827 ± $155,754.

Complications Leading to Litigation

Among all 181 cases, delay in choosing to intubate or reintubate was the most common reason for litigation (24.1%, 51 claims). Non-dental mechanical injury (i.e., vocal cord or nerve damage, pharyngeal soft tissue damage, disc herniation, vertebral artery damage, tracheal tear, subglottic stenosis, or GI tract damage) was second (17.5%, 37 claims), followed closely by technical error in intubating or extubating (15.1%, 32 claims). Alleged failure to monitor and detect extubation or misplaced endotracheal tubes accounted for the fourth highest number of lawsuits (11.8%, 25 claims) (Figure 2).

Figure 2. Reasons for litigation. *Other: Cardiologist (2), neurologist (2), dental surgeon (1), radiologist (1), specialty not specified (5).

Anesthesiologists accounted for the majority of defendants (56.1%, 119 claims). Among anesthesiologists, the most common reason for litigation was damage to bodily structures during intubation (32.8%, 39 claims). Only 20.5% of these injury cases involved tooth or jaw damage (e.g., dislodgement of the temporomandibular joint); the other 79.5% involved various non-dental injuries, such as vocal cord damage, nerve injury, cervical disc herniation, pharyngeal damage, neck hyperextension, subglottic stenosis, and GI tract damage. The second most common reason for anesthesiologist litigation involved a technical failure in intubation (14.3%, 17 cases), either performance of an esophageal or right mainstem bronchus intubation or failure to use a tube exchanger when it was argued to have been the standard of care. The third most common reason for litigation of anesthesiologists was a failure to timely detect inadvertent patient extubation, esophageal intubation, right mainstem bronchus intubation, or bronchospasm (13.5%, 16 claims), followed by claims of a delay in choosing to intubate or reintubate a patient (9.2%, 11 claims), including cases in which BiPAP or an LMA was utilized in the interim. Anesthesiology was the specialty for which the lowest percentage of total malpractice cases involved delay in intubation (9.2%); the overall average for this type of claim was 24.1% of malpractice cases across all specialties. Premature extubation was cited as a litigation reason in 8.4% (10) of lawsuits against anesthesiologists, compared with lawsuits against pulmonologists (5.3%, 1 case), and internists (10.0%, 1 case). Allegations that the physician should have performed a tracheotomy sooner or had done so improperly were seen in 4.2% of claims against anesthesiologists, compared with 10.8% of those against emergency medicine (EM) physicians and 5.3% of those against surgeons (Figure 3). The choice of an inappropriate intubation plan, such as sedation when a difficult airway should have been anticipated, failure to minimize aspiration risk, or failure to administer a paralytic agent, was cited as the reason for litigation in 2.5% (3) of lawsuits against anesthesiologists, compared with EM physicians (8.1% of 37 claims), surgeons (5.3% of 19 claims), and pulmonologists (12.5% of 16 claims).

Figure 3. Reasons for litigation against anesthesiologists. LMA, laryngeal mask airway.

EM physicians were the second most litigated specialty (17.5%, 37 claims) and were sued primarily for delay in intubation (32.4%, 12 cases) and technical failures in intubating (18.9%, 7 cases), with allegations of delay more than triple the frequency seen among anesthesiologists (32.4% vs. 9.2%). Delay in intubation also was the most common allegation against surgeons (47.4% of 19 claims), pulmonologists (68.8% of 16 claims), and internists (50% of 10 claims). Both cases against cardiologists claimed technical failure in intubating. The sole dental surgeon and radiologist moonlighting in emergency medicine in this data set were litigated for technical failure in intubating (Figure 2).

Injuries from Intubation by Anesthesiologists

Injuries from intubation were the most common reason for litigation only among anesthesiologists, with 26.1% of claims against anesthesiologists for various non-dental physical injuries, including vocal cord, nerve, pharyngeal soft tissue, and GI tract damage. A total of 6.7% of lawsuits were due to tooth dislodgement or jaw injuries (Figure 4). Of all injury claims against anesthesiologists, 23.1% concluded in plaintiff victories, with an average payment of $1,683,062 ± $1,853,435. Five cases (12.8%) reached settlement, with an average reward payment of $558,000 ± $411,865, and one case concluded in a mixed verdict for a payout of $375,000. The physician was victorious in 61.5% of injury cases, compared with a 39.0% victory rate for all cases against anesthesiologists. The defendant anesthesiologist was victorious in 62.5% of cases alleging dental injury and in 61.3% of non-dental injury cases. Injury during intubation was claimed in only 10.8% of cases against emergency medicine physicians and in no cases against pulmonologists.

Verdict Outcomes

The average plaintiff verdict award was $7,151,327 ± $18,420,717, due largely to a single case awarding over $114,000,000. With this case excluded, the average plaintiff verdict award was $4,425,870 ± $5,187,945. The average settlement payment was $1,898,145 ± $4,910,054, with one settlement payout listed as confidential. Emergency medicine physicians saw the second highest mean plaintiff payouts (six cases, $4,834,833 ± $6,132,766) (see Figure 4) with the exception of pulmonologists (three cases, $39,273,178 ± $65,470,469), again due to a single case, and followed closely by anesthesiologists (25 cases, $4,558,074 ± $5,541,020). Lawsuits against anesthesiologists were more likely to conclude in plaintiff victory (25.0%, 25 cases), with the second lowest rate of physician victory after internists (39.0% vs. 37.5%), whereas lawsuits against pulmonologists were the most likely to result in defendant victory (66.7%, 10 cases). Cases involving surgeons saw a plaintiff victory rate of 11.8% (two cases), a settlement rate of 29.4% (five cases), and the highest mean settlement payouts ($2,511,400 ± $2,198,826). Pulmonologists saw the lowest rate of settlement (6.7%, one case) (Figure 5).

Figure 4. Injury lawsuits against anesthesiologists. *Vocal cord or nerve damage, pharyngeal soft tissue damage, disc herniation, vertebral artery damage, injury from neck hyperextension, tracheal tear, subglottic stenosis, or GI tract damage.

Figure 5. Verdict outcomes. EM, emergency medicine *Other: Cardiologist (2), neurologist (2), dental surgeon (1), radiologist (1), not specified (5).

Case Outcomes by Injury Severity

Of the total 181 cases of intubation complications, 58.0% (105) involved patient death, 19.9% (36) were due to sequelae of neurological insult (anoxic/hypoxic brain injury, sustained cognitive impairment, paralysis), and 22.1% (40) were due to non-neurological injury. Across all allegation types, cases involving patient death had the highest rate of settlement (38.1%, 40 cases) and the lowest rate of plaintiff victory (15.3%, 16 cases). Non–neurological injury cases had the lowest rate of settlement (7.5%, three cases) and the highest rate of defense verdicts (62.5%, 25 cases). Neurological injury cases resulted in the largest mean plaintiff verdict payments ($15,361,765 ± $31,866,666) and mean settlement payouts ($7,227,500 ± $11,461,210), followed by cases involving patient death (mean plaintiff payment: $4,853,89 ± $5,507,152, mean settlement payment: $953,011 ± $621,492). Non-neurological injuries saw the lowest rates of plaintiff payments ($1,536,207 ± $1,696,945) and settlement payments ($288,333 ± $255,261) (Figure 6).

Figure 6. Outcomes by injury severity.

Discussion

Anesthesiology was the most commonly litigated specialty in this study of intubation-related malpractice claims, which is not unexpected given that they perform the highest percentage of intubations overall. Their trial outcomes and reasons for litigation did differ from other specialties, however. Delay in intubation or reintubation was the most common reason for litigation among all specialties, but it was only the fourth most common reason for anesthesiologists, a group for which damage to bodily structures was the most common reason for lawsuits (32.8% of anesthesiologist cases, 80% of which were non–tooth/jaw injuries). The second most common reason for litigation among anesthesiologists was technical failure, which was the third most common reason overall. The significantly lower proportion of lawsuits for delay in intubation or reintubation among anesthesiologists may reflect the increased experience and training of this group in recognition and maintenance of an adequate airway. Lawsuits against anesthesiologists were most likely to result in plaintiff victory (25%, 25 cases) compared with those against emergency medicine physicians (20%, 6 cases) or surgeons (12%, 2 cases), and there was only small variance in mean payments between specialties after accounting for the single disproportionate plaintiff payment. Neurological injuries from intubation resulted in the highest payments, likely based on the immense healthcare expenses and plaintiff burdens caused by significant neurological injuries.

The review of malpractice claims provides a lens through which to view complications in healthcare delivery. Few studies have focused specifically on malpractice data for intubation as a procedure, particularly across specialties.

Among anesthesiologists, 46% report constant fear of litigation, and 41% are concerned about the financial consequences of lawsuits.

The ever-present potential for litigation is a reality not lost on practicing physicians. Among anesthesiologists, 46% report constant fear of litigation, and 41% are concerned about the financial consequences of lawsuits.(13) The Anesthesia Closed Claims Project has been an ongoing effort by the field of anesthesiology to analyze and learn from malpractice lawsuits,(14-16) and although limited research has been done using this database to observe trends in intubation malpractice,(6) further research is needed, especially as anesthesia malpractice payments continue to increase over time.

The results of our study can be used to target areas of further research and practice improvement in anesthesiology. For instance, given that most of the intubation malpractice cases among anesthesiologists in this study alleged damage to bodily structures other than dental (teeth or jaws), and vocal cord damage represented 31.6% of these injuries, further research may target strategies to decrease this complication, such as selection of appropriate endotracheal tube size by ultrasonographically measuring the internal width of the cricoid.(17) Alleged neck hyperextension resulting in cervical spinal cord paralysis or vertebral artery compression and stroke was present in 10.5% of these claims. “In-line stabilization” is a common strategy to reduce the incidence of such injury with the presence of an unstable cervical spine. Randomized trials comparing the efficacy of various types of laryngoscopes while maintaining in-line stabilization have been conducted(9-21) and should be ongoing, with the goal of optimizing intubation conditions while preserving a degree of in-line stabilization that actually decreases the risk of nerve injury. Many prior studies have examined intubating conditions (Cormack and Lehane grade view) as an outcome without considering whether the degree of in-line stabilization provided is actually beneficial to the patient. Regarding the second most common reason for intubation-related litigation among anesthesiologists in this study, technical failure, future research may focus on novel methods of prediction of difficult airways, such as ultrasound-guided measurement of a patient’s “pre-epiglottic space thickness” at the level of the thyrohyoid membrane.(22)

Although VerdictSearch is a powerful search tool, it presented several limitations to our study design. The database is limited to the states, courts, and attorneys who actually elect to complete this reporting. It is likely that many cases related to intubation malpractice were not included, geographic variety may not be accurately represented, and reporting biases may exist. Nevertheless, VerdictSearch is a useful tool for generating large amounts of detailed data on intubation-related malpractice lawsuits, enabling the observation of distinct trends in factors contributing to lawsuit outcomes.

Conclusion

This is the first known study to examine malpractice data related to intubation across multiple medical specialties and to identify the specific mechanisms responsible for alleged intubation failure. Although it is routinely performed, intubation presents a risk of multiple complication types that may result in serious patient harm. This study views this issue through the lens of malpractice reporting to observe the clinical factors contributing to patient injury. Delay in intubation was the most commonly alleged causative factor in intubation malpractice suits, except among anesthesiologists, for whom injury during intubation was most common. This information can be a valuable guide for quality improvement and research regarding the most effective ways to avoid intubation complications. Further investigation into the factors contributing to intubation complications is warranted, as the cases in this study reflect only a small sample of intubation procedures performed. Overall, a better understanding of the components of intubation malpractice cases has immense potential to improve both practitioner-provided care and patient health.

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