COVID-19 Vaccine Injury Compensation Program: Lessons Learned From a Review of 10 Implementing Countries.

National vaccine injury compensation serves as a crucial and significant safety net for individuals affected by government-recommended vaccines during a pandemic, contributing to the community's overall safety. In the Republic of Korea, compensation for adverse events resulting from coronavirus disease 2019 (COVID-19) vaccinations has been provided through the National Vaccine Injury Compensation Program introduced in 1995. However, there have been limitations with these measures during the COVID-19 pandemic owing to strict criteria for substantiating causality between the vaccine and injury, its nontransparent process of determining whether to compensate, and the compensation amount that is not practically calculated. This article reviewed the Vaccine Injury Compensation Programs in 10 major countries to present implications for improving the Korean system. Expanding the scope of national accountability is essential to compensate for the consequences of adhering to national policies during public health crises. Therefore, valuable insight can be obtained from examining the systems in Germany, Japan, and Taiwan, which have implemented more relaxed criteria for determining causality in compensation cases; Thailand's system, which provides the mandatory payment of preliminary compensation for damage caused by vaccination; systems in Germany, France, and Japan, which offer compensation for vaccine injuries from a practical perspective; and systems in France and the United Kingdom, which have a process allowing the assessment records to be shared with the claimants. Furthermore, a dedicated agency for vaccine injury compensation, as seen in France, the United Kingdom, and Australia, is necessary to enhance the efficiency of the Korean system.

Exploring the Factors that Drive Clinical Negligence Claims: Stated Preferences of Those Who Have Experienced Unintended Harm.

BACKGROUND: Better understanding of the factors that influence patients to make a financial claim for compensation is required to inform policy decisions. This study aimed to assess the relative importance of factors that influence those who have experienced a patient safety incident (PSI) to make a claim for compensation. METHOD: Participants completed an online discrete choice experiment (DCE) involving 10 single profile tasks where they chose whether or not to file a claim. DCE data were modelled using logistic, mixed logit and latent class regressions; scenario analyses, external validity, and willingness to accept were also conducted. RESULTS: A total of 1029 participants in the United Kingdom responded to the survey. An appropriate apology and a satisfactory investigation reduced the likelihood of claiming. Respondents were more likely to claim if they could hold those responsible accountable, if the process was simple and straightforward, if the compensation amount was higher, if the likelihood of compensation was high or uncertain, if the time to receive a decision was quicker, and if they used the government compensation scheme. Men are more likely to claim for low impact PSIs. DISCUSSION AND CONCLUSIONS: The actions taken by the health service after a PSI, and people's perceptions about the probability of success and the size of potential reward, can influence whether a claim is made. Results show the importance of giving an appropriate apology and conducting a satisfactory investigation. This stresses the importance around how patients are treated after a PSI in influencing the clinical negligence claims that are made.

Litígios no Brasil: Ressarcimento do SUS

Em 21 de maio de 2019, a União, representada pela Advocacia Geral da União (AGU), ajuizou uma ação civil pública contra as maiores fabricantes de cigarro do país, visando o ressarcimento de gastos do Sistema Único de Saúde (SUS) com o tratamento de doenças atribuíveis ao tabagismo. Por meio dessa medida, a União busca reaver aos cofres públicos as despesas tidas com o tratamento de 26 doenças, nos últimos 5 anos, para as quais esteja cientificamente comprovado que a causa foi o consumo ou o contato com a fumaça do cigarro. A AGU também requer o pagamento de prestações periódicas pelos gastos que o sistema de saúde público terá no futuro com esses tratamentos e o pagamento de indenização por danos morais coletivos.

Do vaccines cause epilepsy? Review of cases in the National Vaccine Injury Compensation Program.

OBJECTIVE: The National Childhood Vaccine Injury Act of 1986 created the National Vaccine Injury Compensation Program (VICP), a no-fault alternative to the traditional tort system. Since 1988, the total compensation paid exceeds $5 billion. Although epilepsy is one of the leading reasons for filing a claim, there has been no review of the process and validity of the legal outcomes given current medical information. The objectives were to review the evolution of the VICP program in regard to vaccine-related epilepsy and assess the rationale behind decisions made by the court. METHODS: Publicly available cases involving epilepsy claims in the VICP were searched through Westlaw and the US Court of Federal Claims websites. All published reports were reviewed for petitioner's theories supporting vaccine-induced epilepsy, respondent's counterarguments, the final decision regarding compensation, and the rationale underlying these decisions. The primary goal was to determine which factors went into decisions regarding whether vaccines caused epilepsy. RESULTS: Since the first epilepsy case in 1989, there have been many changes in the program, including the removal of residual seizure disorder as a vaccine-related injury, publication of the Althen prongs, release of the acellular form of pertussis, and recognition that in genetic conditions the underlying genetic abnormality rather than the immunization causes epilepsy. We identified 532 unique cases with epilepsy: 105 with infantile spasms and 427 with epilepsy without infantile spasms. The petitioners' experts often espoused outdated, erroneous causation theories that lacked an acceptable medical or scientific foundation and were frequently criticized by the court. SIGNIFICANCE: Despite the lack of epidemiological or mechanistic evidence indicating that childhood vaccines covered by the VICP result in or aggravate epilepsy, these cases continue to be adjudicated. After 35 years of intense litigation, it is time to reconsider whether epilepsy should continue to be a compensable vaccine-induced injury.

A review of China's compensation program for adverse reactions following immunization.

Vaccination is a compelling measure to battle infectious diseases and protect public health. However, because of the constraints on human cognition, it is difficult to ensure that vaccines are safe. Adverse reactions to immunization can cause individual injury. In numerous countries, no-fault programs have been established to compensate individuals for vaccine-related injuries. China also established a vaccine injury compensation system with its own unique characteristics. The Vaccine Administration Law was promulgated in 2019 to establish a compensation system for those who experience adverse reactions following immunization; nevertheless, the compensation system is imperfect. Even when the applicable terms are applied to deal with vaccine-related injuries, some issues remain, such as unreasonable diagnosis and evaluation procedures for adverse reactions, excessively strict standards regarding proof and inconsistent compensation standards across the country. Therefore, to provide effective compensation for vaccine recipients, it is important to clarify the standards of proof and establish a sensible vaccine injury compensation system that includes Corona Virus Disease 2019 vaccine-injury compensation.

The Association Between Orthopaedic Surgeon Academic Productivity Metrics and Compensation from Medical Industry.

INTRODUCTION: Academic research has value well beyond personal financial gain. However, these endeavors do require a notable amount of time and opportunity cost. Academic productivity may raise a researcher's profile within the field, increasing the likelihood for interactions with the medical industry and possibly cultivating relationships with future monetary significance. METHODS: Queries of the Centers for Medicaid and Medicare Services publicly available Open Payments System allowed for extraction of industry compensation data for orthopaedic surgeons. Aggregate data produce three compensation groups (mean annual income) for individual physicians: none; 1 to $100,000; and >$100,000. Physicians in the highest income category were matched 1:1 with physicians in each of the other two compensation groups. Selected physicians then underwent an academic productivity assessment. Queries of Web of Science, Scopus, and Google Scholar User Profile databases provided the h-index and m-index for each surgeon. Bivariate and multivariate analyses produced statistical results. In addition to the analysis of the tiered income groups, analysis of compensation as a continuous variable also occurred. RESULTS: From 2016 to 2020, 636, 7,617, and 22,091 US orthopaedic surgeons earned mean annual industry compensation >$100,000; between $1 and $100,000; and $0, respectively. Royalties (80.8%) predominated in the top earning group, compared with Consulting Fees (46.5%) in the second-tier group. The highest income group had higher h-index ($0 versus $1 to 100,000 versus >$100,000 = 3.6 versus 7.5 versus 20.0, P < 0.001) and m-index ($0 versus $1 to 100,000 versus >$100,000 = 0.26 versus 0.44 versus 0.80, P < 0.001) scores than either the intermediate or no compensation groups. In addition, h-index and m-index correlated positively with total compensation (h-index: r = 0.32, P < 0.001; m-index: r = 0.20, P < 0.001). Multivariable analysis of factors associated with increased industry compensation identified h-index (B = 0.034, P < 0.001) and years active (B = 0.042, P < 0.001) as having significant associations with physician compensation. Physician subspecialty also correlated with industry compensation. DISCUSSION: Academic research can provide invaluable contributions to the improvement of patient care. These efforts often require notable personal sacrifice with minimal direct remuneration. However, academic productivity metrics correlate positively with industry compensation, highlighting a possible supplementary benefit to scholarly efforts. LEVEL OF EVIDENCE: Level III.

Plaintiff aims in medical negligence disputes: limitations of an adversarial system.

The adversarial nature of medical negligence litigation is subject to frequent criticism by the media, patient advocates, and scholars. In Ireland, reform of the medical negligence dynamic is often mooted, particularly in response to the high financial costs of this type of litigation; however, change in this area has been slow. Recently, the Irish courts have dealt with a number of high-profile, medical negligence disputes, including claims for those affected by the CervicalCheck controversy, which involved the failure to disclose the results of a retrospective audit to women who had developed cervical cancer. These cases have again highlighted the shortcomings of an adversarial system. This article explores the limitations of the tort system in the context of plaintiff aims in medical negligence disputes, drawing on empirical findings (qualitative interviews with patient support groups and barristers), and the literature. In doing so, the article argues that while financial compensation is necessary and appropriate in cases of medical negligence, the current system fails to recognise the often emotional nature of these claims, and the wider needs and aims of litigants involved in these disputes.

Percepção de danos físicos, psíquicos e sociais no trabalho de ser mãe universitária / Perception of physical, psychological, and social damages in the work of being college student mothers / Percepción de los daños físicos, sociales y psicológicos en el trabajo de ser madre universitaria

A vida universitária de mulheres mães apresenta questões que precisam ser mediadas quando comparadas com a mesma dinâmica em estudantes que não são mães. O referencial teórico da psicodinâmica do trabalho reconhece o estudar e o maternar como trabalho, pois demandam esforço cognitivo, físico e temporal com finalidade social. O objetivo deste artigo foi avaliar os danos advindos desses dois trabalhos, sobretudo, em suas dimensões física, psicológica e social, na vida de mães universitárias com filhos de até cinco anos de idade. Utilizou-se a metodologia quantitativa com ajuda da aplicação da Escala de Avaliação dos Danos Relacionados ao Trabalho (EADRT), e adaptada para o contexto estudantil e materno. A pesquisa foi respondida por 453 mães universitárias. Dessa forma, foi encontrada uma amostra heterogênea, cujas respostas apontaram para diferenças na percepção dos danos; correlações dos fatores; e associações com as variáveis sociodemográficas. Logo, discute-se a presença de danos físicos, sociais e psicológicos considerados graves para as duas atividades. No entanto, quando as mães universitárias residem com um companheiro ou têm maior renda, os danos sociais e psicológicos se mostraram menores. Com efeito, esta pesquisa ampliou o conhecimento sobre quem são as mães brasileiras na graduação e que tipo/grau de danos à saúde elas vivenciam, destacando que o acúmulo dos dois papéis acarreta níveis críticos que podem ser atenuados pelo apoio familiar e pela assistência às questões de vulnerabilidade econômica. Por fim, reforça-se a preocupação em analisar cientificamente essas realidades, servindo de embasamento para políticas públicas e estratégias futuras de intervenção.(AU)

The student life of college mothers shows complementary issues that need to be evaluated when compared with the same dynamic in students that are not mothers. The theoretical framework of the psychodynamics of work recognizes studying and mothering occupations as work activities, since they demand cognitive, physical, and temporal effort with a social purpose. The aim of this article was to assess the damage arising from these two workloads, especially, in their physical, psychological, and social dimensions, to the lives of women undergraduate students who have children up to five years old. We used a quantitative methodology with the application of the Work-Related Damage Assessment Scale (EADRT), adapted to the university and maternity context. The scale was answered by 453 college student mothers. Thus, we found a heterogeneous sample, whose answers pointed to variations in the perception of damage; correlations between factors; and connections with the socio demographic variables. Therefore, we discuss the presence of physical, social, and psychological damages considered severe for both activities. However, when the student mothers live with a partner or have a higher income, the social and psychological damage are lesser. In conclusion, this study expanded the knowledge about who are the Brazilian undergraduate student mothers and the type/degree of damages to their health they experienced, highlighting that the build-up of the two roles leads to critical levels that can be mitigated by family support and by assistance to issues concerning economic vulnerability. Finally, the importance to scientifically analyze these realities, serving as foundation for public policies and future intervention strategies, is reinforced.(AU)

La vida universitaria de madres tienen demandas diferentes que necesitan discusión en la comparación con la vida universitaria de mujeres que no son madres. El marco teórico de la psicodinámica de trabajo reconoce el papel de madre y de estudiante como trabajos, ya que para hacerlos se requiere esfuerzo cognitivo, físico y temporal, con finalidad social. El objetivo de este estudio es avaliar los daños que acompañan estos dos trabajos en sus dimensiones física, psicológica y social, en la vida de mujeres brasileñas estudiantes de grado que tienen hijos de hasta 5 años de edad. Se utilizó la metodología cuantitativa a partir de la aplicación de la Escala de Evaluación de Daños Relacionados al Trabajo (EADRT), adaptada al contexto estudiantil y de maternidad. La encuesta fue respondida por 453 madres universitarias. Como resultado, se encontró una muestra heterogénea, con diferencias entre la percepción de daños, correlaciones entre los factores y asociaciones entre los daños y variables sociodemográficas. Se discute la presencia de daños físicos, sociales y psicológicos considerados graves para los dos papeles. Sin embargo, cuando las madres universitarias viven con un compañero o tienen ingresos más grandes, los daños sociales y psicológicos son menores. Se concluye que este estudio permitió ampliar el conocimiento acerca de las madres brasileñas en el grado y qué tipo/nivel de los daños a la salud tienen, que destaca que la acumulación de los papeles genera niveles críticos que pueden ser mitigados por el apoyo familiar y asistencia en cuestiones de vulnerabilidad económica. Se destaca la preocupación por analizar científicamente las realidades de madres universitarias, sirviendo de base para políticas públicas y estrategias de intervenciones futuras.(AU)

Occupational lung diseases in South African miners at autopsy: 2020 surveillance report

The Pathology Division at the National Institute for Occupational Health (NIOH) provides autopsy services for deceased workers who worked in controlled mines or works under the provisions of the South African Occupational Diseases in Mines and Works Act, 1973 (Act No. 78 of 1973). This report describes the ages, commodities, employment durations, and occupational cardio-respiratory diseases in miners whose organs were submitted for autopsies in 2019 and 2020. Data were exported from the PATHAUT database into STATA for analysis. Differences in the proportions of disease (expressed per 1 000) were calculated using the Pearson's chi-square test; significance was set at p ≤ 0.05. There were 759 and 557 records of deceased miners and ex-miners in 2019 and 2020, respectively. Pulmonary tuberculosis decreased from 192/1 000 in 2019 to 153/1 000 autopsies in 2020, and silicosis decreased from 246/1 000 to 223/1 000. However, neither decrease was significant. There was a significant increase in the rate of asbestosis from 50/1 000 in 2019 to 79/1 000 in 2020. Pulmonary tuberculosis (TB), emphysema, and silicosis were the most frequent diseases, with high rates. There was a non-significant decrease in occupational respiratory disease rates in 2020 from 2019, but these remain higher than the rates seen in the early 1990s. The NIOH continues to conduct autopsy surveillance on miners to support compensation for families, and the development of policy and intervention programmes in the mining industry

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.

Surgical Error Compensation Claims as a Patient Safety Indicator: Causes and Economic Consequences in the Murcia Health System, 2002 to 2018.

OBJECTIVES: Compensation claims are a useful source of information on patient safety research. The purpose of this study was to determine the main causes of surgical compensation claims and their financial impact on the health system. METHODS: A descriptive observational study with analytical components was carried out on compensation claims brought against the surgical area of the Murcia Health System between 2002 and 2018. We analyzed the frequency, causes, consequences, locations and surgical settings of these claims, the time of judicial procedure, and compensation adjusted to the Consumer Price Index. RESULTS: There were 1172 compensation claims. "orthopedic surgery and traumatology" (27.4%), "gynecology and obstetrics" (25.7%), and "general surgery" (17.2%) were the main surgical settings involved. The most frequent causes were surgical error (42.4%) and treatment error (30.9%). The main sequelae were musculoskeletal (20.0%), neurological (17.7%), and obstetric (17.7%). The average time from incident to resolution of claims was 6.3 years. A total of 20.1% of these claims were successful, particularly those involving retained surgical foreign bodies (71.4% successful claims; P < 0.001). The total compensation paid was €56,338,247 (an average of €17,207 per claim). Compensation was higher in cases with respiratory sequelae (median, 131,600; P = 0.033), death (75,916; P < 0.001), and neurological (60,000; P = 0.024). CONCLUSIONS: Compensation claims associated with surgical procedures are made on a variety of grounds. They are drawn-out proceedings, and patients are only successful in 20% of cases.

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.