Medical Malpractice Litigation Following Spine Surgery in Beijing: The Past 6 Years.

Background: Spine surgeons in particular face the most hostile liability environment among the surgical specialties. Systemic studies related to spine surgery litigation in China is absent. The aim of this study was to analyze the characteristics of medical malpractice litigation involving spine surgery in Beijing for the past 6 years. Methods: Two online legal databases, Wusong and Weike, were queried for court verdicts involving spine surgery from Jan 2013 to Dec 2018 in Beijing. For all included cases, data pertaining to defendants, plaintiffs, case outcomes, allegations, and verdicts were abstracted, and descriptive analyses were performed. Results: A total of 186 legal cases were examined, 122 cases were excluded due to irrelevance or insucient information. Of the 64 cases included in this investigation, 40.6% of them were male. The mean age of the plaintiffs was 53.2 ± 18.6 years. The most common complaint addressed in this study is dissatisfaction with consent (53.1%, n=34), followed by additional surgery required (40.2%, n=26), unsatisfactory outcome to surgery (17.6%, n=11), postoperative paralysis (15.6%, n=10) and postoperative infection (15.6%, n=10). The most common primary disease among all the cases is lumbar spinal stenosis (28.1%, n=18), followed by spinal tumor (18.8%, n=12), cervical spondylosis (17.2%, n=11), vertebral fracture (14.1%, n=9), deformity (12.5%, n=8) and others (9.3%, n=6). Spine surgeons successfully defended themselves in 13 cases (20.3%), which resulted in no indemnity payment. The rest 51 cases (79.7%) were closed with an average verdict payout of 155,562 Yuan, which was signicant lower than the average compensation claimed by the plaintiff (783,172 Yuan) (p < 0.05). Conclusions: Identifying the most common reasons for litigation and summarizing their characteristics may help decrease litigation rate and improve the patient experience. Further investigations with larger sample size and more complete

Understanding which claims have led to litigation against spine surgeons in China, as well as the distribution and nature of these claims, is critical in being able to help doctors protect both themselves and their patients as well.
The purpose of this study was to present a snapshot of the medical malpractice litigation involving spine surgery in Beijing, the capital city of mainland China with a resident population of 25 million, for the past 6 years.

Methods
Publicly available court verdicts related to spine surgery malpractice litigation in Beijing, from January 2013 to December 2018, were identi ed in two online legal databases (Westlaw and Weike). These databases provide online legal research service for lawyers and legal professionals which can provide information regarding national cases in China. Court verdicts were obtained using the search terms "Beijing", "spine", "surgery", and "malpractice". Exclusion criteria included duplicate cases, unrelated topics, and lack of reported data. Each case le was then thoroughly reviewed and data pertaining to defendants, plaintiffs, case outcomes, allegations, and verdicts were abstracted, and descriptive analyses were extracted. Severity of damage was graded from minor/temporary to death. Data analysis was carried out using Excel and Graphpad, and statistical signi cance was calculated using a two-tailed Student's t-test.

Results
In total, 186 cases were identi ed from the two databases initially; 81 cases were repeated and 41 cases were excluded for missing information or irrelevance, leaving a total of 64 cases for nal analysis. (Fig. 1) The mean age of the plaintiffs was 53.2 ± 18.6 years; 26 cases (40.6%) of the plaintiffs were male and 38 cases (59.4%) were female. Among all the included medical malpractice cases, 55 cases (86.0%) occurred in public hospital while 9 cases (14.1%) occurred in private ones. As for the spine surgeon's specialty, 45 cases (70.3%) involved orthopedic surgeons, 11 cases (17.2%) involved neurosurgeons, and 8 cases (12.5%) did not specify it. There are 39 cases (60.9%) of rst instance, 24 cases (37.5%) of second instance and 1 case of retrial.
To glean a better understanding of the motivating force behind each claim, an attempt was made to isolate the main issues from the patient's perspective. As shown in Fig. 2, dissatisfaction with consent (53.1%, n = 34) is the most commonly cited reason for litigation, followed by additional surgery required (40.6%, n = 26), unsatisfactory outcome to surgery (17.2%, n = 11), postoperative paralysis (15.6%, n = 10), postoperative infection (15.6%, n = 10) and delay in diagnosis (14.0%, n = 9). Intraoperative nerve injury (9.4%, n = 6), and breakage of internal xation (7.8%, n = 5) were less common causes for concern. Of note, among the 10 cases of postoperative paralysis, four patients already developed degenerated muscle strength or even incomplete paralysis before the rst surgery. Among the 9 cases with the claim of delay in diagnosis, there are 5 cases of spinal tumor, 2 cases of spinal tuberculosis, 1 case with lumbar brucellosis spondylitis, and 1 case with vertebra fracture. Two cases (3.1%) complained with wrong level during percutaneous vertebroplasty in the treatment of vertebral body compression fracture.
The most likely outcome of included litigation was a jury verdict in favor of the plaintiff, as shown in Yuan to appease the plaintiffs out of humanitarian concerns.

Discussion
In the past few years, with the rapid improvement of national economy and the enhancement of public legal awareness in mainland China, more and more patients choose litigation instead of private settlement as the solution of medical malpractice. Effective learning from litigation continues to be important since it allows good practice to be shared and has the potential to reduce the number of litigations. Most importantly, this learning can improve the safety and quality of patient care, and to reduce the costs of litigation.
In this study we looked at 64 cases brought against spine surgeons from the period of 2013-2018 in Beijing. To our knowledge, our study represents the very rst detailed analysis of malpractice claims against spine surgeons in China.
In current study, more than half of the litigations have a claim of dissatisfaction with consent (53.1%, n = 34), underscoring the particular importance of communication and documentation in the patientphysician relationship in China. We noted that this proportion is extremely higher compared with that of previous published studies from other countries. (4,(10)(11)(12)(13)(14)(15)(16) However, it appears to be consistent with the previous study conducted by Grauberger  Our study also found "additional surgery required" resulted in a large percentage of claims (40.6%, n = 26). Actually we found an average number of operations at 2.4 (range 1-7) in our included cases. This can also explain the lengthy time (average 4.5 years, range 1.2-9.5 years) from the rst operation to the end of verdict observed in current study. In this study most multiple operations resulted from surgical site infection, breakage of internal xation, or inadequate decompression. Those conditions always come with extraordinarily high medical cost, which is unaffordable to most Chinese families and means going into debt since the scope of the medical insurance coverage is limited and the quality is spotty.
We noticed that spine surgeons successfully defended themselves in 13 cases (20.3%) of lawsuits in our study, which appears to be different with the ndings from other countries. In England, Quraishi et al. 15  It seems that spinal surgeons in Beijing are more likely to lose the litigation compared with their western country counterparts. This may be explained by the differences in providing evidences among medical malpractice litigation in Chinese legal systems. For a patient (plaintiff) to win a malpractice litigation suit in western countries, he/she must demonstrate that a physician was negligent. However things are far different in China since 2002 when the People's Supreme Court issued a regulation to invert the evidential burden in medical malpractice litigation, aimed improving the situation of information asymmetry between patient and physician. In other words, the defendant physician needs to demonstrate him/herself not guilty by providing full and complete documentation in malpractice litigation in China.
Malpractice litigation is costly from a nancial perspective, and its monetary burden on healthcare systems worldwide keeps rising (4,(18)(19)(20)(21) Epstein's study (16) showed We noticed that orthopedics accounts for the majority of the involved subspecialty compared with neurosurgery in current study. That is probably because spine surgery was o cially listed as one of the subspecialties of orthopedics rather than neurosurgery according to the Chinese Medical Association. In the authors' experience, most of spine surgeries are carried out by orthopedist in China. Also we found that most of the malpractice cases occurred in public hospitals rather than private ones. Perhaps the immaturity of market-oriented allocation of medical resources during the reform of medical care system may help explaining and understanding this phenomenon (22,23).
Our study had several potential confounding factors that may prevent us from drawing rm conclusions from the data available. First of all, although court records are available via legal databases, reporting of cases is not mandatory and is at the discretion of individual court systems and judges. The cases captured may not represent all of the cases in Beijing and may not represent the true distribution of the different reasons for lawsuits and decisions. Secondly, the databases contain only cases with a court verdict and do not include cases that were dropped/discarded at an earlier stage. Out-of-court settlements may not have been led under court records. Given that a majority of claims do not end into trial, it is unsurprising that our analysis may only captured a fraction of the total number of claims in Beijing. Finally, the information presented in these cases is primarily legal in nature and medical details from most cases are not publicly reported, which limits the available information on claims.

Conclusions
We have presented the results of the rst systematic review of malpractice claims for spine surgery in China. A plaintiff's verdict was reached in the majority of the enrolled cases in current study. Dissatisfaction with consent and additional surgery required were the top two frequently cited bases for litigation. Further larger sample sized investigations are needed to reveal the true reasons for lawsuits and to examine the ongoing trends in China.

List Of Abbreviations
None.

Declarations
Ethics approval and consent to participate Not applicable

Consent for publication
Not applicable Availability of data and materials The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Competing interests
Not applicable Funding This study is supported by the China Postdoctoral Science Foundation Grant, Grant NO: 2018M641389. The funding body supported the design of the study and collection, analysis, and interpretation of data.
Authors' contributions SX designed the whole study. DH and SG collected the primary dataset. HL and FS performed the data analysis. DH and SX drafted the manuscript. DH and SG contributed equally to this work. All authors have read and approved the manuscript.