Analysis of medical malpractice liability disputes related to novel antineoplastic drugs and research on risk prevention and control strategies
Jinyu Luo ,Zaoqian Zheng ,Rongliang Yu
Abstract
Objective
To investigate the general characteristics of litigation cases of medical malpractice liability disputes (MMLDs) related to novel antineoplastic drugs (NADs), the drugs involved, as well as the common types of medical errors related to NADs and their damages in the process of diagnosis and treatment, with the aims of improving the level of rational medication use in the clinical application of NADs and actively prevent medical disputes.
Methods
The China Judgments Online was searched for the cause of action using the key word “MMLDs” along with the name of 77 kinds of NADs. A total of 39 NAD litigation cases meeting the inclusion criteria from 1 January 2009 to 31 December 2021 were analyzed, and each potential adverse drug reaction (ADR) was reviewed to determine a causality assessment using the Naranjo algorithm for non-drug-induced liver injury (DILI) cases and the updated Roussel Uclaf Causality Assessment Method (RUCAM) for the DILI cases. Risk prevention and control strategies were recommended.
Introduction
Novel antineoplastic drugs (NADs) refer to small molecule-targeted drugs and macromolecular monoclonal antibodies, which are commonly used to treat cancer [1]. Cancer is the leading cause of death in China and developed countries [2], and has become a major public health problem in China [3]. The number of cancer cases and deaths, as well as crude incidence and mortality of cancer in China, have increased gradually since 2000 [4], and there will be an estimated 4,820,000 new cases of cancer, and 3,210,000 cancer-related deaths in China in 2022 [5]. Based on the current treatment of malignant tumors, traditional chemotherapy drugs can no longer fully meet the clinical needs [6]. Targeting NADs at specific sites can reduce the side effects to some extent and significantly improve the mortality and poor prognosis of tumor patients [5]. In 2018, the National Health Commission of China issued the first edition of the Guiding Principles for the Clinical Application of NADs (hereafter referred to as the GPCANADs) [7], which has been updated each year and has now been updated to the fifth edition (2022) [8].
Material and methods
Data sourcing and search strategy
The China Judgments Online is a unified platform provided by the Supreme People’s Court of China for the publication of judicial documents from all Courts across the Country [20]. Litigation cases are published on this platform after judgement. This platform has been used previously to analyze MMLD litigations throughout China [21]. All information used in this study was obtained from publicly available court records and no confidential or protected health records were obtained. Therefore, no approval from an Institutional Review Board was required, and the requirement for informed consent was waived. Participants’ identities were not required during or after data collection.
Results
Literature retrieval and study characteristics
The search strategy yielded a total of 356 judgments, of which 173 were excluded after removal of duplicates. Another 125 judgments that did not fall within the scope of the study based on full-text assessment were excluded. Of the remaining 58 judgments, 39 cases met all the inclusion criteria. The judgment selection flow diagram is shown in Fig 1. The literature retrieval and study characteristics are presented in S1 Table.
Discussion
Characteristics of litigation cases of NAD-related MMLDs
We found that 41.03% of the cases proceeded to the second or retrial and execution process, which is significantly lower than our previous research on severe cutaneous ADRs (55%) [21], which may be more acceptable to patients given the results of verdicts awarding payments for damages caused by NADs compared to the damage caused by severe cutaneous ADRs. However, medical service providers should still pay attention to the rational use of NADs. The original judgement for the majority (81.25%) of the cases was upheld in the second or retrial cases. However, the execution of the second instance or retrial increased the costs of litigation and delayed the dispute resolution.
Conclusion
Our study investigates the MMLD litigation related to NADs, analyzes its general characteristics, causative drugs, resulting injuries and medical errors, and gives examples of typical cases. Based on our study, we put forward risk prevention and control strategies for NADs. Through case studies, the intent was to support clinicians in further improving their understanding of NAD-related litigation, learn about common medical errors related to NADs, and take preventive strategies to reduce MMLDs. Both doctors and patients may make better choices to resolve MMLDs through consultation, which can save time and litigation costs. The number of NAD litigation cases has increased rapidly in the past six years, which is related to the improvement of the accessibility of NADs in China and the clinical application of additional, new NADs.
Acknowledgments
The authors wish to thank two Referees and an Academic Editor for their thoughtful comments and suggestions on an earlier version of the manuscript.
Citation: Luo J, Zheng Z, Yu R (2023) Analysis of medical malpractice liability disputes related to novel antineoplastic drugs and research on risk prevention and control strategies. PLoS ONE 18(6): e0286623. https://doi.org/10.1371/journal.pone.0286623
Editor: Andrea Cioffi, University of Foggia: Universita degli Studi di Foggia, ITALY
Received: September 6, 2022; Accepted: May 22, 2023; Published: June 5, 2023
Copyright: © 2023 Luo et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: All relevant data are within the paper and its Supporting information files.
Funding: (ZZ)Zhejiang Public Technology and Policy Science (social science) Applied Research Project (grant number 2020C35071)http://kjt.zj.gov.cn/; (ZZ)Zhejiang Medical Science and Technology Project (grant number 2020KY086)https://wsjkw.zj.gov.cn/; (ZZ)Zhejiang Traditional Chinese Medicine Science and Technology Project (grant number 2022ZB074)https://wsjkw.zj.gov.cn/.
Competing interests: The authors have declared that no competing interests exist.
