Malpractice litigation in elective lumbar spinal fusion: a comprehensive review of reported legal claims in the U.S. in the past 50 years

Abstract

Background context: In the U.S., medical malpractice litigation is associated with significant financial costs and often leads to the practice of defensive medicine. Among medical subspecialities, spine surgery is disproportionately impacted by malpractice claims.

Purpose: To provide a comprehensive assessment of reported malpractice litigation claims involving elective lumbar spinal fusion (LSF) surgery during the modern era of spine surgery instrumentation in the U.S., to identify factors associated with verdict outcomes, and to compare malpractice claims characteristics between different approaches for LSF.

Study design/setting: A retrospective review.

Patient sample: Patients undergoing elective lumbar spinal fusion surgery.

Outcome measures: The primary outcome measure was verdict outcome (defendant vs. plaintiff verdict). Secondary outcome measures included alleged malpractice, injury/damage claimed, and award payouts.

Methods: The Westlaw legal database (Thomson Reuters, New York, NY, USA) was queried for verdict and settlement reports pertaining to elective LSF cases from 1970 to 2021. Data were collected regarding patient demographics, surgeon specialty, fellowship training, state/region, procedure, institutional setting (academic vs. community hospital), alleged malpractice, injury sustained, case outcomes, and monetary award.

Results: A total of 310 cases were identified, yielding 67% (n=181) defendant and 24% (n=65) plaintiff verdicts, with 9% (n=26) settlements. Neurosurgeons and orthopedic spine surgeons were equally named as the defendant (45% vs. 51% respectively, p=0.59). When adjusted for inflation, the median final award for plaintiff verdicts was $1,241,286 (95% CI: $884,850-$2,311,706) while the median settlement award was $925,000 (95% CI: $574,800-$1,787,130), with no stastistically significant differences between verdict and reported settlement payouts (p=0.49). The Northeast region displayed significantly higher award payouts compared to other U.S. regions (p=0.02). There were no associations in awards outcomes when comparing alleged malpractice, alleged injuries/damages, institutional setting, surgical procedures, and surgeon specialty or fellowship training. The most common claims were intraoperative error (28%, n=107) followed by failure to obtain informed consent (24%, n=94). In the analyzed cohort, the most common injuries leading to litigation were refractory pain and suffering (37%, n=149) followed by permanent neurological deficits (26%, n=106). There were no differences in alleged malpractice or injury sustained between cases in which the outcome was favorable to defendant versus plaintiff. Anterior lumbar interbody fusion (ALIF) cases were 2.75 times more likely to be cited for excessive or inappropriate surgery (OR: 2.75 [95% CI: 1.14, 6.86], p=0.02) when compared to posterior surgical approaches.

Conclusion: The results of our analysis of reported claims suggest that medical malpractice litigation involving elective LSF is associated with jury verdicts over $1 million per case, with the most common alleged malpractice being intraoperative error and failure to obtain informed consent. Surgeon specialty, fellowship training, procedure type, and institution type were not associated with greater litigation risks; however, ALIF surgery had a significantly higher risk of involving claims of excessive or inappropriate surgery compared to posterior approaches for lumbar fusion. In addition, claims were significantly higher in the Northeast compared to other U.S. regions. Efforts to improve patient education through shared-decision making and proactive strategies to avoid, detect, and mitigate intra-operative procedural errors may decrease the risk of litigation in elective LSF.

Keywords: Informed Consent; Litigation; Lumbar fusion; Malpractice; Spine surgery; Tort reform.