Accepted Manuscript Title: The medico-legal landscape of spine surgery: how do surgeons fare? Author: Melvin C. Makhni, Paul J. Park, Jesus Jimenez, Comron S. Saifi, JonMichael Caldwell, Alex Ha, Bianca Figueroa-Santana, Ronald A. Lehman Jr, Mark Weidenbaum PII: DOI: Reference:
S1529-9430(17)30312-1 http://dx.doi.org/doi: 10.1016/j.spinee.2017.06.038 SPINEE 57378
To appear in:
The Spine Journal
Received date: Revised date: Accepted date:
6-3-2017 19-4-2017 26-6-2017
Please cite this article as: Melvin C. Makhni, Paul J. Park, Jesus Jimenez, Comron S. Saifi, JonMichael Caldwell, Alex Ha, Bianca Figueroa-Santana, Ronald A. Lehman Jr, Mark Weidenbaum, The medico-legal landscape of spine surgery: how do surgeons fare?, The Spine Journal (2017), http://dx.doi.org/doi: 10.1016/j.spinee.2017.06.038. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
The Medico-legal Landscape of Spine Surgery: How Do Surgeons Fare?
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Authors:
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Melvin C. Makhni MD MBA, Paul J. Park MD, Jesus Jimenez, Comron S. Saifi MD, Jon-
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Michael Caldwell MD, Alex Ha MD, Bianca Figueroa-Santana, Ronald A. Lehman Jr MD, Mark
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Weidenbaum MD
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Department of Orthopaedic Surgery
Columbia University Medical Center The Spine Hospital at New York Presbyterian 15 16 Corresponding Author: Melvin C. Makhni, MD MBA 5141 Broadway, 3 Field West New York, NY 10034 Columbia University Medical Center, USA Tel: 212-305-4565 Fax: 212-305-6193 17
Email:
[email protected] 18 19 20 21 1 Page 1 of 20
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Abstract
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Background Context
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Due to the limited and confidential nature of most legal data, scarce literature is available to
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physicians about reasons for litigation in spine surgery. In order to optimally compensate
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patients while protecting physicians, further understanding of the medico-legal landscape is
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needed for high-risk procedures such as spine surgery. Based on these, surgeons can explore
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ways to better protect both their patients and themselves.
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Purpose
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To characterize the current medico-legal environment of spine surgery by analyzing a recent
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dataset of malpractice litigation.
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Study Design
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A retrospective study.
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Patient Sample
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All malpractice cases involving spine surgery available to public query between the years of
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2010 to 2014.
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Outcome Measures
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Case outcome for spine surgery malpractice cases between the years of 2010 to 2014.
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Methods
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WestlawNext was used to analyze spine surgery malpractice cases at the state and federal level
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between the years 2010 and 2014. WestlawNext is a subscription based, legal search engine that
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contains publicly available federal and state court records. All monetary values were inflation
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adjusted for 2016. One hundred three (103) malpractice cases were categorized by case
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descriptors and outcome measures. Claims were categorized as either intraoperative complaints
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or preoperative complaints.
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Results
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Rulings in favor of the defendant (surgeon) were noted in 75% (77/103) of the cases. Lack of
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informed consent was cited in 34% of cases. For the 26 cases won by the plaintiff, the average
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amount in settlement was $2,384,775 versus $3,945,456 in cases brought before a jury. Cases
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involving consent averaged a compensation of $2,029,884 while cases involving only
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intraoperative complaints averaged a compensation of $3,667,530. A significant correlation was
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seen between increased compensation for plaintiffs and cases involving orthopaedic surgeons (p
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= 0.020) or nerve injury (p = 0.005). Wrong level surgery may be associated with lower plaintiff
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compensation (p = 0.055). The length of cases resulting in defense verdicts averaged 5.51 years,
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which was significantly longer than the 4.34 years average length of settlements or verdicts in
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favor of plaintiffs (p = 0.016).
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Conclusions
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Spine surgeons successfully defended themselves in 75% of lawsuits, although the cases won by
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physicians lingered significantly longer than those settled. Better understanding of these cases
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may help surgeons to minimize litigation. More than 1/3 of cases involved a claim of
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insufficient informed consent. Surgeons can protect themselves and optimize care of patients
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through clear and documented patient communication, education, and intraoperative vigilance to
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avoid preventable complications.
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Keywords: medico-legal; spine surgery; medical malpractice; informed consent; wrong level;
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nerve injury; compensation; settlement; jury; medical error
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INTRODUCTION Despite increasing calls for malpractice reform, lawsuits continue to heavily affect
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physicians of all specialties. Orthopaedic surgeons and neurosurgeons have borne a
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disproportionately higher number of lawsuits than doctors from other specialties [1]. Spine
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surgeons in particular are likely at higher risk given the severity of potential complications that
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can be encountered including chronic pain, numbness, and paralysis.
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The current medico-legal system places significant financial, time, and emotional burdens
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on physicians. The medical liability system costs the healthcare system approximately $55
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billion annually, adding to the rise in overall healthcare costs [2]. In addition to these
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expenditures, the average claim lasts about 43 months; orthopaedic surgeons and neurosurgeons
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spend a significant amount of time during their careers with an open claim [3]. During this time,
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the lawsuits can serve as a mental and emotional stressor, leading to significantly higher levels of
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surgeon burnout [4]. Nearly all physicians reported experiencing emotional distress with an
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estimated 1/3 facing symptoms of major depressive disorder [4, 5]. However, despite the
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widespread prevalence of burdensome claims, in which 80% of physicians in surgical specialties
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will face a claim by 45 years old, only 22% involved payments from the physician [1]. As a
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result, these high costs associated with malpractice have contributed to the increasing practice of
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“defensive medicine”, in which physicians order additional tests, imaging, procedures or visits
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with the primary goal of preventing litigation or to defend oneself should it occur [6].
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In order to reform this system and optimally compensate patients while protecting
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physicians, further understanding of the medico-legal landscape is needed – especially in high-
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risk areas such as spine surgery. Various studies have attempted to understand malpractice
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issues around spinal cord injury and cauda equina syndrome, yet little is known about patient
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complaints leading to malpractice claims [7-11].
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To our knowledge this is the most recent, detailed analysis of spine surgery malpractice
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claims. Most case files are either sealed or individually located at courthouses, so this also
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represents one of the largest studies of current primary legal data possible. We looked at all
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intraoperative and preoperative patient complaints filed in medical malpractice lawsuits across a
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broad range of states at both the federal and state level, regardless of outcome. Understanding
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which claims have led to successful cases against physicians, as well as the distribution and
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nature of these claims, is critical in being able to help doctors protect both themselves and their
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patients as well.
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MATERIALS AND METHODS For this medico-legal study, WestlawNext was used to analyze spine surgery malpractice
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cases at the federal and state level between the years 2010 and 2014. WestlawNext is a
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subscription based, legal search engine that contains publicly available federal and state court
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records obtained by numerous vendors, and has been used in numerous other medical
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malpractice studies [12–16]. We queried the WestlawNext database for spine AND surgery
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AND medical malpractice, and looked at the “Jury Verdicts and Settlements” database to
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evaluate the spine surgery malpractice cases that involved orthopaedic surgeons and/or
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neurosurgeons. The format of the resulting case files varied; cases with insufficient information
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including case outcome or settlement amount were excluded. Each case file was then thoroughly
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reviewed and key data was extracted including: state, lawsuit outcome, type of surgery, anatomic
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location of surgery and the plaintiff’s complaint. We further examined each case to determine the
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cost, in the case of a settlement or a plaintiff verdict, to the surgeon.
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Claims made against surgeons in the lawsuits were categorized as follows: technical or
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errors in judgment (which includes complaints of judgment errors in diagnosis and treatment),
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nerve injury, wrong level surgery, retained foreign body, and issues with informed consent. For
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further analysis, issues with informed consent were defined as “preoperative”, while other
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complaints were grouped as “intraoperative”. All monetary values were inflation adjusted for
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2016. Significant differences were defined as having a p < 0.05. The dataset was assessed for
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normality using a Shapiro-Wilk test and was found to not follow a normal distribution.
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Therefore, categorical variables were evaluated using a chi-square test and nominal variables
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were evaluated using a Mann-Whitney U t-test. Statistics were computed using JASP 0.8.0.0
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statistical software (JASP Team, 2016).
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RESULTS A total of 103 spine cases were analyzed from 36 states: 49 cases involved orthopedic
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surgeons, 42 cases involved neurosurgeons, and 12 cases did not specify the spine surgeon’s
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specialty.
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Rulings in favor of the defendant (surgeon) were noted in 75% (77/103) of the
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malpractice suits. In 25% (26/103) of the cases, the plaintiff received financial compensation.
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Out of the total number of law suits ending in plaintiff compensation, 50% (13/26) were settled
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out of court and 50% (13/26) were ruled in favor of the plaintiff (patient) by a jury. In the 26
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trials won by the plaintiff, the average plaintiff compensation was $3,165,116. Of these, cases
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that went before a jury had an average payout of $3,945,456, whereas there was a lower average
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compensation of $2,384,775 for settlements though the difference was not statistically significant
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(p = 0.614). Overall, 34% of cases (35/103) involved an issue with consent (preoperative), of
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which 8 led to plaintiff compensation, averaging a $2,029,883 payout (this may be either an
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isolated consent issue or in conjunction with an intraoperative claim). Of 68/103 cases in which
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consent was not involved, 18 cases concluded in plaintiff compensation averaging $3,667,530
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(Table 1).
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Of the total number of procedures, there were 27 cervical, 8 thoracic, and 64 lumbar
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surgeries (Figure 1). The five most common complaints addressed in this study included
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technical/judgment (67 cases), nerve injury (42 cases), lack of informed consent (35 cases),
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wrong level surgery (5 cases), and foreign body after surgery (2 cases) (Figure 2).
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Technical/judgment complaints were the most common claims in the overall cohort; this
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remained consistent across anatomic groups (59% of cervical cases, 63% of thoracic cases, and
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66% of lumbar cases) (Figure 3). Consent was disproportionately more involved in lumbar cases
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at 41%, versus 22% of cervical cases and 13% in thoracic cases (Figure 3). The anatomic
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location of the surgery (cervical, thoracic, lumbar) demonstrated no significant difference in trial
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outcome. No statistically significant correlation was seen between any of the complaint
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categories and the outcome of the verdict; no significance was found with preoperative vs.
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intraoperative complaints and verdict as well. Lastly, the type of surgeon (neurosurgery vs.
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orthopaedic surgery) had no association with trial outcome, though orthopaedic surgery cases did
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have a significantly larger payout (p = 0.020) in cases with plaintiff compensation. A significant
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correlation was also seen with increased payouts awarded for cases involving nerve injury (p =
5
0.005), while wrong level claims may be associated with lower compensations (p = 0.055).
6
The average time from filing a suit to obtaining a verdict/settlement was 5.25 years. The
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length of cases resulting in defense verdicts averaged 5.51 years, which was significantly longer
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than the 4.35 years average length of settlements or verdicts in favor of plaintiffs (p = 0.016). Of
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those in favor of the plaintiff, the average duration of settled cases was 3.78 years vs. 4.74 years
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for cases that went before a jury (Table 2).
11 12 13
DISCUSSION Malpractice litigation continues to be a significant issue in spine surgery, and places a
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significant burden on not only spine surgeons but the healthcare system overall as well. Our
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study looked at 103 cases brought against spine surgeons from the period of 2010-2014, a recent
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snapshot of the ever-shifting medico-legal landscape. Our study represents the most recent,
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detailed analysis of malpractice claims to our knowledge against spine surgeons focusing on
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patients’ legal complaints. While prior series of spine claims have shown that surgeons win as
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few as 38% of cases, our series of recent data suggests that surgeons win 76% of lawsuits [17].
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However, we also noted that when surgeons successfully defend themselves, cases are prolonged
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27% longer than when surgeons lose or settle. We also noted that a large percentage of lawsuits
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(34%) have a primary or secondary claim of insufficient informed consent prior to surgery.
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A study of cervical spine surgery malpractice suits from 1990 to 2000 by Epstein et al
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described 63 cases against spine surgeons [17]. They found that 76% of cases were against
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neurosurgeons, while we found that 46% of cases were against neurosurgeons. The duration of
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trial and financial awards to plaintiffs were comparable to those in our study. However, in their
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study physicians only successfully won 38% of cases, which is significantly less than the 75% of
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all cases (78% of cervical cases) successfully defended in our study, which is comparable to
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other recent studies [1]. This study had a smaller sample size than our series and also included
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cases from the 1990’s, so results from this study may not be as applicable today as our study of
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more recent data.
10
In a study looking at malpractice cases involving spinal cord injury from 2000-2010,
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Quigley et al found similar average monetary awards and noted that physicians are more likely to
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successfully defend a lawsuit that resulted from an error in treatment rather than an error in
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diagnosis [9]. While Quigley’s study focused only on spinal cord injury, our study is more
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generalizable to spine surgeons due to its larger number of cases and inclusion of a broad
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spectrum of complaints against spine surgeons. Further, their study encompassed cases from
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more than fifteen years prior, while we only included cases since 2010 to ensure relevance with
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the current medico-legal environment.
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Missios et al performed a large database study of spine surgery patients from 2005-2010
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and found no association between increased claims and mortality [18]. However, due to the
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large database nature of their study, they were exposed to coding inaccuracies and also had very
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limited granular information about the cases so were not able to include details about rates of
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patient claims, reasons for lawsuits, payouts awarded, or other factors analyzed in our study.
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Another area of interest for spine surgeons with regards to malpractice is cauda equina
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syndrome (CES) and associated adverse outcomes. Daniels et al demonstrated that a decreased
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length of time until operation from CES symptom onset (