Injuries and deaths following Covid-19 vaccination: The ethical and legal case for compensation.

In April 2024, in a class action suit for compensation to families of persons suffering injury or death after vaccination with AstraZeneca's (AZ) Covid-19 vaccine [1], the manufacturer admitted in a UK court that the Oxford-AZ Covid-19 vaccine could cause a rare and potentially fatal blood clotting disorder ("thrombosis with thrombocytopenia syndrome" or TTS, which when triggered by a vaccine is called "vaccine induced thrombocytopenia and thrombosis, or VITT) [2]. The AZ Covid-19 vaccine is a chimpanzee adenovirus vectored vaccine encoding the SARS-CoV2 spike protein (ChAdOx1-S) marketed under the names Covishield and Vaxzevria.

Civil Monetary Penalties for EMTALA Violations Involving Minors, 2002-2023.

BACKGROUND AND OBJECTIVES: The Emergency Medical Treatment and Labor Act (EMTALA) is intended to prevent inadequate, delayed, or denied treatment of emergent conditions by emergency departments (EDs). EMTALA requirements pertain to patients of all ages presenting to dedicated EDs regardless of whether facilities have dedicated pediatric specialty services. This study aims to describe EMTALA-related civil monetary penalty (CMP) settlements involving minors. METHODS: Descriptions of all EMTALA-related CMPs occurring between 2002 and 2023 were obtained from the Office of the Inspector General web site and reviewed for involvement of minors (<18 years of age) using keywords in settlement summaries. Characteristics of settlements involving minors were described and compared with settlements not involving minors. RESULTS: Of 260 EMTALA-related CMPs, 38 (14.6%) involved minors. Most involved failure to provide a medical screening exam (MSE) (86.8%) and/or stabilizing treatment (52.6%). Seven (18.4%) involved pregnant minors. Eleven (28.9%) involved ED staff directing a patient (or guardian) to another facility, typically by private vehicle, and another involved 2 patients referred to on-campus outpatient clinics without an MSE. CONCLUSIONS: One in 7 CMPs related to EMTALA violations involved minors, and 1 in 5 of these minors was pregnant. One-third of CMPs involving minors included ED staff directing patients to proceed to another facility or on-campus clinic without MSE or stabilization. Findings suggest a need for providers to understand EMTALA-specific requirements for appropriate MSE, stabilization, and transfer, and for EDs at hospitals with limited pediatric services to implement policies for the evaluation of minors and protocols for transfer when indicated.

Loss of chance: the uncertainty of the event or the uncertainty of the conduct? Case Series and Medicolegal Considerations.

Background: The concept of damages for loss of chance originated in France in 1877 and was adapted to healthcare in 1962. In Italy, it was first introduced in healthcare liability in 2004, with Civil Court of Cassation decision No. 4400. Italian jurisprudence recognizes the loss of chance as an independent, legally and economically assessable damage, distinct from the actual outcome lost. The landmark St. Martin Judgments of 2019 further established that such damages can be claimed if they involve appreciable, serious, and consistent values. This requires proving a causal link between the conduct and the lost chance, based on established civil law criteria. Case report: 1) a 71-year-old man whose lung carcinoma was not diagnosed in time, leading to a significant reduction in survival chances. 2) a woman whose breast cancer diagnosis was delayed, resulting in a more advanced stage and decreased survival prospects. Discussion: In medical professional liability, the Supreme Court requires a high probability or certainty of causation for recognizing the causal link between wrongful conduct and damage. The assessment involves proving both the causal link and the reasonable probability of a lost opportunity's realization. Hypothetical damage is insufficient for compensation. Conclusions: The compensability of loss of chance relies on proving the causal link between the negligent act and the uncertain event, where the impact on the patient's non-pecuniary sphere is significant. Medicolegal practice faces challenges in distinguishing between causality and damage, which can lead to confusion between biological damage and damage from loss of opportunity.

Psychiatric Illness and Clinical Negligence: When Can "Secondary Victims" Successfully Claim for Damages? Recent Developments from the United Kingdom.

On January 11, 2024, the United Kingdom (U.K.) Supreme Court rendered its judgment in Paul v Royal Wolverhampton NHS Trust, restricting the circumstances in which "secondary victims" can successfully claim for damages in clinical negligence cases. This ruling has provided welcome clarity regarding the scope of negligently caused "pure" psychiatric illness claims, but the judgment may well prove controversial. In this article, I trace the facts and opinion from the majority and also discuss an important dissenting opinion. I then reflect on what the ruling means for psychiatric illness claims by secondary victims, and more broadly on the implications for clinical negligence law. I suggest that while much-needed clarity has been injected in this area of the law, it is difficult, reading the majority of the Supreme Court's emphasis on the restricted scope of a medical practitioner's duty, to envision a scenario in which secondary victim could ever succeed in a clinical negligence context.

Reasons for malpractice claims after primary total hip arthroplasty in France: Insurance data from 240 claims from 2014 to 2017.

INTRODUCTION: Total hip arthroplasty (THA) is one of the most frequent orthopedic surgery procedures, and orthopedic surgeons are among the most frequently accused of malpractice by their patients. Identifying the main reasons for malpractice claims after THA is a prior condition to reducing their frequency. The quality of the preoperative risk information given to the patient by the surgeon is crucial for these purposes. Data specific to THA are sparse in France, and we therefore conducted a retrospective study (1) to determine whether the outcome of medico-legal expert appraisal correlated with the quality and traceability of preoperative information, and (2) to identify the most frequent grounds for complaint after primary THA. HYPOTHESIS: The quality of patient information partly determines expert appraisal. MATERIAL AND METHOD: A retrospective study was conducted based on data from the Branchet medical professional insurance agency for malpractice claims following THA over the period 2014-2017, with 240 complete files, for 125 women and 115 men. Data comprised: type of procedure, main grounds of complaint (complications), positive or negative expert appraisal, quality of preoperative patient information, amounts of compensation accorded and fees paid, and the practitioner's liability. We assessed correlations between information quality and liability. RESULTS: Surgical site infection and neurologic deficit were the two main grounds for malpractice claims. In the 240 files, cases for 106 operations (44.2%) were submitted to arbitration, 95 (39.6%) were brought to court, and 39 (16.2%) were settled out of court. The practitioner was held at least partly liable in 40 files (16.7%). Information to the patient was deemed imperfect or poor for 119 files (49.6%) and good in 121 (50.4%). Mean compensation was €30,940 (range, €0 to €198,100). In 27 of the 40 cases of liability (67.5%), the information to the patient was deemed imperfect or poor. Twenty-six of the 40 cases (65%) were settled out of court. In case of poor information, there was a significant risk for the practitioner to be held liable: 7.5 vs. 25% (p=0.003). DISCUSSION: The present study listed the main complications underlying malpractice claims after THA: infection, neurologic complications, and limb-length discrepancy. This should enable practitioners to improve patient information so as to reduce the rate of malpractice claims or at least decrease the practitioner's liability, as the study found a correlation between information quality and expert appraisal. LEVEL OF EVIDENCE: IV; retrospective study.

Risk management and empirical study of the doctor-patient relationship: based on 1790 litigation cases of medical damage liability disputes in China.

BACKGROUND: Compensation for medical damage liability disputes (CMDLD) seriously hinders the healthy development of hospitals and undermines the harmony of the doctor-patient relationships (DPR). Risk management in the DPR has become an urgent issue of the day. The study aims to provide a comprehensive description of CMDLD in China and explore its influencing factors, and make corresponding recommendations for the management of risks in the DPR. METHODS: This study extracted data from the China Judgment Online - the official judicial search website with the most comprehensive coverage. Statistical analysis of 1,790 litigation cases of medical damage liability disputes (COMDLD) available from 2015 to 2021. RESULTS: COMDLD generally tended to increase with the year and was unevenly distributed by regions; the compensation rate was 52.46%, the median compensation was 134,900 yuan and the maximum was 2,234,666 yuan; the results of the single factor analysis showed that there were statistically significant differences between the compensation for different years, regions, treatment attributes, and trial procedures (P < 0.05); the correlation analysis showed that types of hospitals were significantly negatively associated with regions (R=-0.082, P < 0.05); trial procedures were significantly negatively correlated with years (R=-0.484, P < 0.001); compensat- ion was significantly positively correlated with years, regions, and treatment attributes (R = 0.098-0.294, P < 0.001) and negatively correlated with trial procedures (R=-0.090, P < 0.01); regression analysis showed that years, treatment attributes, and regions were the main factors affecting the CMDLD (P < 0.05). CONCLUSIONS: Years, regions, treatment attributes, and trial procedures affect the outcome of CMDLD. This paper further puts forward relevant suggestions and countermeasures for the governance of doctor-patient risks based on the empirical results. Including rational allocation of medical resources to narrow the differences between regions; promoting the expansion and sinking of high-quality resources to improve the level of medical services in hospitals at all levels; and developing a third-party negotiation mechanism for medical disputes to reduce the cost of medical litigation.

Compensation in Neonatal Clinical Trials: A Perspective.

Well conducted clinical trials are the mainstay for generating evidence on preferred treatments. In order to adequately protect the interests of the trial participants, the Central Licensing Authority of India has formulated guidelines to determine the quantum of compensation in cases of regulatory clinical trial related injury or death. However, these guidelines do not address the nuances of trials recruiting children aged under 16 years, within which, neonates are the most vulnerable population. Thus, there is a need for addressing this lacuna in the current guidelines. This article examines the challenges in determining the quantum of compensation in neonatal clinical trials using the current formula, which is a corollary to the challenges faced by the authors in procuring clinical trial insurance for the Probiotic supplementation for Prevention of Neonatal Sepsis (ProSPoNS) trial. Further, it suggests a template for a differential formula using birthweight of infants, which is one of the many important factors impacting neonatal mortality.

Distribution of Abatement Funds Arising From US Opioid Litigation.

This Viewpoint discusses the settlement agreements reached against several major pharmaceutical distributors resulting from the US opioid epidemic and how those funds will be distributed amongst the states.

Five-year results of no-fault compensation related to childbirth injuries in Taiwan.

OBJECTIVE: Increasing obstetric medical litigations had great impacts in health care system resulted in lower recruitment of residents and higher medical cost of defensive medicine in Taiwan. In order to reduce medical litigation, the "Childbirth Accident Emergency Relief Act" was implemented in June 2016. This study presented five-year results of a novel childbirth accident compensation system. MATERIALS AND METHODS: The purpose of the Relief Act was to establish a national relief system to ensure timely relief, reduce medical disputes, promote the partnership between patient and medical personnel. The compensations included maximal 2 million NTD for maternal death, maximal 0.3 million NTD for neonatal and fetal deaths, and 3, 2, and 1.5 million NTD for maternal or neonatal profound, severe, and moderate disabilities, respectively. Puerperal hysterectomy was included with maximal 0.8 million NTD compensation. RESULTS: Since June 30, 2016 to June 30, 2021, there were 1340 applications reviewed by Committee and 1258 were approved with total relief of 744.7 million NTD (26.6 million USD) with approve rate of 93.9%. It took an average of 109.8 days to start application from childbirth and 102.4 days to get compensation from application. 66.1% of accident victims agreed this system can restore doctor-patient relationship by immediate care and assistance from medical institutions. CONCLUSION: The Relief Act is the first government leading compensation system to establish a national relief system. It was enacted to reduce medical disputes, promote the partnership between patient and medical personnel, and enhance health and safety of women during childbirth. A no-fault compensation would be an efficient alternative disputes resolution to childbirth accidents.

Jury verdicts, outcomes, and tort reform features of malpractice cases involving thoracic outlet syndrome.

OBJECTIVE/BACKGROUND: Thoracic outlet syndrome (TOS) is most often referred to vascular surgeons. However, there is a lack of understanding of the malpractice cases involving TOS. The goal of this study is to better understand the medicolegal landscape related to the care of TOS. METHODS: The Westlaw Edge AI-powered proprietary system was retrospectively reviewed for malpractice cases involving TOS. A Boolean search strategy was used to identify target cases under the case category of "Jury Verdicts & Settlements" for all state and federal jurisdictions from 1970 to September 2020. The settled case was described but not included in the statistical analysis. Descriptive statistics were used to report our findings, and when appropriate. The P ≤ .05 decision rule was established a priori as the null hypothesis rejection criterion to determine associations between jury verdicts outcomes and state's tort reform status. RESULTS: In this study, 39 cases were identified and met the study's inclusion criteria from the entire Westlaw Edge database. Among plaintiffs who disclosed age and/or gender, median age was 35.0 years with a female majority (67.6%). Cases involving TOS were noted to be steadily decreasing since the mid-1990s. The cases were unevenly spread across 18 states, with the highest number of cases (14, 35.9%) from California and the second highest (4, 10.3%) from Pennsylvania. A similar uneven distribution was seen among U.S. census regions, in which the West had the highest cases (39.5%). The study revealed that more cases were brought to trials in tort reform states (26, 68.4%) than in non-tort reform states (12, 31.6%). A total of 24 of 39 (61.5%) plaintiffs had one specific claim, which resulted in their economic and noneconomic damages. Negligent operation and treatment complication represented an overwhelming majority of claims brought by 38 of 39 plaintiffs (97.4%). Misdiagnosis and lack of informed consent were both brought nine times (23.1%) by the group. Intraoperative nerve injury (20 patients, 51.3%) was the most commonly reported complication. Excluding one case with a settlement of $965,000, 30 of 38 (78.9%) cases went to trials and received defense verdicts. Eight cases (20.5%) were found in favor of plaintiffs with a median payout of $725,581. CONCLUSIONS: This study highlighted higher than average payouts to plaintiffs and risk factors that may result in malpractice lawsuits for surgeons undertaking TOS treatment. Future studies are needed to further clarify the relationships between tort reform and outcomes of malpractice cases involving TOS.

A proposal for a legally enforceable no-fault compensation framework for clinical trial-related injury in Malaysia.

Clinical trials play a critical role in the development of life-enhancing and life-sustaining biomedical advances. It is costly and, regardless of how well-designed and ethically conducted, there are always inherent uncertainties which subsequently expose human participants to the risk of injuries or even death. In Malaysia, compensation for clinical trial-related injury has not been incorporated into standard national regulations or policies. Therefore, when clinical trial-related injuries do occur, such participants cannot be compensated by researchers, and with the absence of specific statutory laws governing trial-related injury within the local legal framework, aggrieved parties need to seek legal redress and can only depend on the existing tort laws. To propose a viable compensation framework, the existing compensation regulations and policies implemented in India and South Africa are analyzed, and their best principles have been recommended. This study proposes the implementation of a no-fault compensation framework in Malaysia which should be disbursed efficiently at minimum administrative cost. This proposed approach should be mandated by the amendment of current laws governing biomedical research and, in the interim, should be adopted voluntarily by research sponsors, institutions and investigators conducting clinical trials in Malaysia.

Judicial Vulnerability on the Exercise of Orthodontics: Construction and Validation of a Questionnaire

Abstract Objective: To develop and validate a questionnaire to measure the vulnerability of orthodontists, measuring the risks of being involved in civil liability lawsuits. Material and Methods: In-depth interviews were performed with three groups: G1- law professionals, G2 - orthodontists, and G3 - orthodontic patients. From the analysis of the content of Bardin, domains for the construction of the first version of the 53-question questionnaire were identified. The questionnaire was submitted to experts for validation, inclusion and exclusion of questions, but maintaining the 53-question format. It was submitted to the test-retest phases and verification of internal consistency. Results: 247 professionals answered the final version of the questionnaire. The intraclass correlation coefficient was 88.8%. Cronbach's alpha was 0.946, with high internal consistency. The Kaiser-Meyer-Olkin and Bartlett's tests confirmed internal consistency showing the values of 0.909 and significance of <0.001, respectively. From the total score and factorial analysis, the sample was divided into three groups of judicial vulnerability. Conclusion: The results of this study demonstrated that the questionnaire is a valid tool to measure the risks of involvement in civil liability lawsuits by orthodontists. It presented a multidimensional character and might be applied as well as face to face or online, without prejudice to quality (AU).

Vaccine injury compensation: the Israeli case.

BACKGROUND: Following other countries, Israel passed the Vaccine Injury Compensation Law in 1989, which provides for compensation to vaccine recipients who had suffered injuries without proving negligence. In 2021, after deliberations between the ministries of health and of finance Covid-19 vaccines (administered from the beginning of the campaign on December 20, 2020 and up to December 21, 2022) were included within the compensation law. The current study aims to examine the objectives of Israel's Vaccine Injury Compensation Law, at the time of its enactment, and to explore barriers to their fulfillment. These issues are especially relevant in light of the discussions held on the option for liability exemption which excludes the possibility of redress from the Covid-19 vaccine manufacturers in case of injury attributed to the vaccine, and considering the heavy burden of proof required in standard tort law. METHODS: The study employed a qualitative methodology which made use of both content analysis of relevant documents and in-depth interviews. RESULTS: In passing the Vaccine Injury Compensation Law, legislators sought to assist vaccine recipients who had suffered injuries by both lowering their burden of proof as well as establishing a short and efficient procedure for deliberating their claims. Furthermore, legislators believed that the assurance of compensation to vaccine recipients who had suffered injuries would help to encourage a high rate of vaccination compliance. An examination of the law's implementation over time revealed that the aforementioned goals were not attained. CONCLUSIONS: Implementation of the law since its enactment missed the opportunity to fulfill its original purposes to promote public health fundamental principles of fairness and solidarity. In addition, the adversarial proceedings as well as some of the law's provisions have the potential to undermine public trust in the State's willingness to grant compensation for injuries that are attributed to vaccines and thereby subvert the law's pivotal objective of promoting trust and vaccine compliance. We suggest that allowing circumstantial evidence as to an association between vaccine and an injury, transitioning to administrative deliberation, making available to the public details of cases where compensation was awarded, as well as other possible emendations would help it better reflect the values of fairness and solidarity that underlying the law's purpose. These would also promote the level of trust in healthcare authorities which is essential to preserving high vaccine coverage.

Medico-legal implications for the colon perforation during colonoscopy.

Colon perforation is the most serious complication of colonoscopy, and tends to be considered as malpractice. The aim of this study was to identify the characteristics and causes of medical accidents by analyzing lawsuit cases on colon perforation during colonoscopy. We collected judgment results that were ruled from 2005 to 2015 using the keyword 'colonoscopy' in the 'Korea's Written Judgment Public Reading System' of the Supreme Court, and extracted the cases of colon perforation. Characteristics of medical accidents and the decisions of courts were analyzed from written judgments. Twenty-two lawsuits were analyzed. Most cases were ruled in favor of the plaintiff (n = 20). The allegations against defendants, as filed by the plaintiffs, were performance error (n = 22), improper monitoring after colonoscopy (n = 7), and a lack of informed consent (n = 8). The median compensation was 9335.47 US dollars; this is about 130 times the cost of a single colonoscopy in Korea. The greater the intestinal damage, the greater the amount of compensation (p = 0.016). The time interval from procedure to diagnosis of perforation was most frequently 24 h later (n = 9). It is important to educate patients completely about the symptoms of colon perforation and to guide them to contact medical institutions immediately when symptoms occur. In addition, doctors should explain sufficiently the possibility of perforation before colonoscopy to the patient, and not the caregiver, and get informed consent.

Employer Liability for "Take-Home" COVID-19.

Workplace exposure to SARS-CoV-2 has sickened workers and, subsequently, their family members. Family members might be able to recover from the employer in a negligence action using "take-home" liability theory.

Pigs Don't Fly and You Cannot Expect Absolutely Safe COVID-19 Vaccines (But You Should Expect a Fair Compensation).

This paper focuses on the COVID-19 vaccines authorised for use in the European Union, and explores the mechanisms in place to control vaccine safety and to compensate injured patients, mainly in the context of European law. Based on these considerations, the paper concludes that the refusal by some potential vaccinees to take the vaccine based on safety concerns is ungrounded and an indication of unrealistic expectations, but that in order to build public trust proper compensation mechanisms should be in place.