scholarly journals Products in a Pandemic: Liability for Medical Products and the Fight against COVID-19

2020 ◽  
Vol 11 (3) ◽  
pp. 565-603 ◽  
Author(s):  
Duncan FAIRGRIEVE ◽  
Peter FELDSCHREIBER ◽  
Geraint HOWELLS ◽  
Marcus PILGERSTORFER
Keyword(s):  
Product Liability ◽  
Legal Issues ◽  
Regulatory Regime ◽  
Protective Equipment ◽  
Products Liability ◽  
Medical Products ◽  
Fault Compensation ◽  
Alternative Responses ◽  
The Impact ◽  
European Product

A multitude of medical products are being developed and produced as part of efforts to tackle COVID-19. They are varied in nature and range from test kits to tracing apps, protective equipment, ventilators, medicines and, of course, vaccines. The design, testing and manufacture of many of these products differs from production in normal times due to the urgency of the situation and the rapid increase in demand created by the pandemic. This article considers the legal issues arising as a result of the production of emergency products, particularly from a products liability perspective. To what extent do existing concepts under the European Product Liability Directive, such as defect, causation and the various defences, permit the pandemic to be taken into account when a Court is considering issues of liability? What is the impact on liability of the modified regulatory regime? In light of that discussion, the case for alternative responses is examined from a comparative and European perspective, including the issue of Government indemnities for the manufacturers of products, legal exemptions from liability and alternative no-fault compensation schemes.

Part I United States, 2 The Liquidation of Lehman Brothers Inc, the New York Brokerage of the Lehman Global Enterprise

2017 ◽  
Author(s):  
Caputo Kenneth J ◽  
Giddens James W ◽  
Kiplok Christopher K
Keyword(s):  
New York ◽  
Lessons Learned ◽  
Legal Issues ◽  
Regulatory Regime ◽  
Financial Instruments ◽  
Financial Products ◽  
Lehman Brothers ◽  
Foreign Affiliates ◽  
The Impact

This chapter explores the statutory and regulatory regime in place in 2008 that governed the operation and liquidation of Lehman Brothers Inc. (LBI) and highlights key legal issues in the liquidation. Section I provides an overview of the Securities Investor Protection Act (SIPA) statute. Section II describes LBI, its role as the broker-dealer in the global Lehman enterprise, and the story of its collapse in September 2008. Section III highlights some hallmarks of the LBI liquidation, including the emergency sale to Barclays, account transfers, the transfer of all of LBI’s subsidiaries on the eve of LBI’s filing, the atomization of foreign affiliates with different regulatory regimes, and the role of LBI as a counterparty in the financial products market, which led to a substantial general estate. Section IV addresses the impact of the broker-dealer liquidation under SIPA on the treatment of complex financial instruments. Section V reflects on lessons learned.

scholarly journals The impact of COVID-19 on supply decision-makers: the case of personal protective equipment in Spanish hospitals

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Manuel F. Morales-Contreras ◽  
Marcelo Leporati ◽  
Luciano Fratocchi
Keyword(s):  
Health Care ◽  
Supply Chain ◽  
Personal Protective Equipment ◽  
Health Care Industry ◽  
Decision Makers ◽  
Protective Equipment ◽  
Policy Makers ◽  
Medical Products ◽  
Care Industry ◽  
The Impact

Abstract Background The COVID-19 pandemic has been recognized as a trigger for redefining supply chains at the global level, and has created an intense debate within the academic community and among policy-makers and practitioners. Among other industries, health care has been dramatically hit by the scarcity of “medical products,” specifically for personal protective equipment (PPE-like), due to supply chain disruptions coupled with dramatically increased demand. We aimed to analyze how the scarcity of PPE-like during the COVID-19 pandemic has modified the behavior of decision-makers in the PPE-like supply chain at the hospital level, and to explore what changes could be implemented to cope with future PPE-like shortages. Methods We used an explorative approach based on semi-structured interviews with key informants in the Spanish health care industry. More specifically, we held interviews to industry experts at three hospitals in three Spanish regions to map the consequences of the COVID-19 pandemic onto the buying decision-making process. Results Different strategies were developed by decision-makers at hospitals before, during, and after the first wave of the COVID-19 pandemic in Spain. Our paper offers two main findings: a) decision-makers changed their purchasing behavior from a cost main driver to guaranteeing the availability of supplies; b) they supported the idea of giving more “strategic autonomy” to Spain or Europe through back and nearshoring decisions. Conclusions This paper could be of interest to health care management at the national, regional, and hospital levels, as well as for policy-makers, since it could help to establish and configure policies to support the sourcing of medical products (specifically PPE-like) to anticipate potential supply disruptions. Our paper contributes to the limited existing literature on how purchasing strategies at the decision-maker level and supply vary in the health care industry when a public health crisis appears, and what potential solutions might be for policy-makers and practitioners involved in the health care industry.

Impact of COVID-19 on Nuclear Medicine in Germany, Austria and Switzerland: An International Survey in April 2020

2020 ◽  
Vol 59 (04) ◽  
pp. 294-299 ◽  
Author(s):  
Lutz S. Freudenberg ◽  
Ulf Dittmer ◽  
Ken Herrmann
Keyword(s):  
Nuclear Medicine ◽  
Health Systems ◽  
Personal Protective Equipment ◽  
Large Scale ◽  
Diagnostic Procedures ◽  
Protective Equipment ◽  
Current Crisis ◽  
Web Based ◽  
Public Versus Private ◽  
The Impact

Abstract Introduction Preparations of health systems to accommodate large number of severely ill COVID-19 patients in March/April 2020 has a significant impact on nuclear medicine departments. Materials and Methods A web-based questionnaire was designed to differentiate the impact of the pandemic on inpatient and outpatient nuclear medicine operations and on public versus private health systems, respectively. Questions were addressing the following issues: impact on nuclear medicine diagnostics and therapy, use of recommendations, personal protective equipment, and organizational adaptations. The survey was available for 6 days and closed on April 20, 2020. Results 113 complete responses were recorded. Nearly all participants (97 %) report a decline of nuclear medicine diagnostic procedures. The mean reduction in the last three weeks for PET/CT, scintigraphies of bone, myocardium, lung thyroid, sentinel lymph-node are –14.4 %, –47.2 %, –47.5 %, –40.7 %, –58.4 %, and –25.2 % respectively. Furthermore, 76 % of the participants report a reduction in therapies especially for benign thyroid disease (-41.8 %) and radiosynoviorthesis (–53.8 %) while tumor therapies remained mainly stable. 48 % of the participants report a shortage of personal protective equipment. Conclusions Nuclear medicine services are notably reduced 3 weeks after the SARS-CoV-2 pandemic reached Germany, Austria and Switzerland on a large scale. We must be aware that the current crisis will also have a significant economic impact on the healthcare system. As the survey cannot adapt to daily dynamic changes in priorities, it serves as a first snapshot requiring follow-up studies and comparisons with other countries and regions.

The Impact of Emerging Technologies on the Law of Armed Conflict

2019 ◽  
Keyword(s):  
Armed Conflict ◽  
New Technologies ◽  
Emerging Technologies ◽  
Legal Issues ◽  
Technological Advancement ◽  
Law Of Armed Conflict ◽  
Legal Challenges ◽  
Challenges And Opportunities ◽  
The Law ◽  
The Impact

Emerging technologies have always played an important role in armed conflict. From the crossbow to cyber capabilities, technology that could be weaponized to create an advantage over an adversary has inevitably found its way into military arsenals for use in armed conflict. The weaponization of emerging technologies, however, raises challenging legal issues with respect to the law of armed conflict. As States continue to develop and exploit new technologies, how will the law of armed conflict address the use of these technologies on the battlefield? Is existing law sufficient to regulate new technologies, such as cyber capabilities, autonomous weapons systems, and artificial intelligence? Have emerging technologies fundamentally altered the way we should understand concepts such as law-of-war precautions and the principle of distinction? How can we ensure compliance and accountability in light of technological advancement? This book explores these critical questions while highlighting the legal challenges—and opportunities—presented by the use of emerging technologies on the battlefield.

scholarly journals The impact of COVID-19 pandemic on training and mental health of residents: a cross-sectional study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eman Alshdaifat ◽  
Amer Sindiani ◽  
Wasim Khasawneh ◽  
Omar Abu-Azzam ◽  
Aref Qarqash ◽  
...  
Keyword(s):  
Mental Health ◽  
Residency Training ◽  
Training Programs ◽  
Cross Sectional Study ◽  
Protective Equipment ◽  
Sectional Study ◽  
Cross Sectional ◽  
Surgical Residents ◽  
Tertiary Center ◽  
The Impact

Abstract Background Residency programs have been impacted by the Coronavirus disease 2019 (COVID-19) pandemic. In this study we aim to investigate and evaluate the impact of the pandemic on residents as well as residency training programs. Methods This was a cross-sectional study including a survey of 43 questions prepared on Google forms and electronically distributed among a convenience sample of residents training at a tertiary center in North Jordan during the COVID-19 pandemic. Data were collected in the period between October 30th and November 8th of 2020. The survey included questions that addressed the impact of the pandemic on residents’ health as well as training programs. The study participants included residents in training at KAUH in 2020 and were stratified according to the type of residency program (surgical residents (SRs) and non-surgical residents (NSRs)). Statistical methods included descriptive analysis, Chi-square or Fisher’s exact test, Mann Whitney U test, and Cramer’s V and r statistics as measures of effect sizes. Results Of all 430 residents, 255 (59%) responded to the survey. A total of 17 (7%) of residents reported being infected with COVID-19 and a significant difference was reported between SRs and NSRs (10% vs 4%, V = .124 “small effect” (95% CI; .017–.229), p = 0.048). Approximately, 106 (42%) reported a decrease in the number of staff working at the clinic and 164 (64%) reported limited access to personal protective equipment during the pandemic. On a 4-point Likert scale for the feeling of anxiety, the median was 2 (2–3 IQR) in the NSRs group, vs 2 (1–2 IQR) in the SRs groups, with the NSRs being more likely to feel anxious (r = 0.13 “small effect” (95% CI; 0.007–0.249), p = .044). Similarly, the proportion of residents who reported feeling anxious about an inadequacy of protective equipment in the work area was significantly greater in the NSRs group (90.3% vs 75.2%; V = .201 “small effect” (95% CI; .078–.313), p = .001), as well as the proportion of residents who reported feeling increased stress and anxiety between colleagues being also significantly higher in the NSRs group (88.1% vs 76%; V = .158 “small effect” (95% CI; .032–.279), p = .012). Conclusion The burden of the ongoing pandemic on the mental health status of residents is very alarming and so providing residents with psychological counseling and support is needed. Also, critical implications on the flow of residency training programs have been noticed. This necessitates adapting and adopting smart educational techniques to compensate for such limitations.

scholarly journals The patient advisor, an organizational resource as a lever for an enhanced oncology patient experience (PAROLE-onco): a longitudinal multiple case study protocol

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
M. P. Pomey ◽  
M. de Guise ◽  
M. Desforges ◽  
K. Bouchard ◽  
C. Vialaron ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Clinical Oncology ◽  
Patient Experience ◽  
Emotional Support ◽  
Social Care ◽  
Legal Issues ◽  
Care Services ◽  
Health And Social Care ◽  
Ethical And Legal Issues ◽  
The Impact

Abstract Background Quebec is one of the Canadian provinces with the highest rates of cancer incidence and prevalence. A study by the Rossy Cancer Network (RCN) of McGill university assessed six aspects of the patient experience among cancer patients and found that emotional support is the aspect most lacking. To improve this support, trained patient advisors (PAs) can be included as full-fledged members of the healthcare team, given that PA can rely on their knowledge with experiencing the disease and from using health and social care services to accompany cancer patients, they could help to round out the health and social care services offer in oncology. However, the feasibility of integrating PAs in clinical oncology teams has not been studied. In this multisite study, we will explore how to integrate PAs in clinical oncology teams and, under what conditions this can be successfully done. We aim to better understand effects of this PA intervention on patients, on the PAs themselves, the health and social care team, the administrators, and on the organization of services and to identify associated ethical and legal issues. Methods/design We will conduct six mixed methods longitudinal case studies. Qualitative data will be used to study the integration of the PAs into clinical oncology teams and to identify the factors that are facilitators and inhibitors of the process, the associated ethical and legal issues, and the challenges that the PAs experience. Quantitative data will be used to assess effects on patients, PAs and team members, if any, of the PA intervention. The results will be used to support oncology programs in the integration of PAs into their healthcare teams and to design a future randomized pragmatic trial to evaluate the impact of PAs as full-fledged members of clinical oncology teams on cancer patients’ experience of emotional support throughout their care trajectory. Discussion This study will be the first to integrate PAs as full-fledged members of the clinical oncology team and to assess possible clinical and organizational level effects. Given the unique role of PAs, this study will complement the body of research on peer support and patient navigation. An additional innovative aspect of this study will be consideration of the ethical and legal issues at stake and how to address them in the health care organizations.

scholarly journals Assessing the Impact of Alternative Responses to COVID-19: Stopping the Spread in Newfoundland and Labrador, Canada

2021 ◽  
Vol 44 (2) ◽  
pp. 238-245
Author(s):  
Michael G. Chislett ◽  
Paige T. Phillips ◽  
Brett Snider ◽  
Edward A. McBean ◽  
John Yawney ◽  
...  
Keyword(s):  
Newfoundland And Labrador ◽  
Alternative Responses ◽  
The Impact

scholarly journals Occupational burnout following the first wave of coronavirus disease at a Welsh district general hospital

2021 ◽  
pp. 175114372110100
Author(s):  
Gayathri Chinnappa Srinivas ◽  
Anwen Whitham ◽  
Rachel Rouse ◽  
Vincent Hamlyn ◽  
Matthew Williams
Keyword(s):  
Health Care Professionals ◽  
Response Rate ◽  
District General Hospital ◽  
Learning Opportunities ◽  
Direct Patient Care ◽  
Protective Equipment ◽  
Positive Outcomes ◽  
Occupational Burnout ◽  
Staff Burnout ◽  
The Impact

A survey was conducted to identify the prevalence of occupational burnout amongst health care professionals caring for COVID-19 patients in the Intensive Care Unit (ICU) of a Welsh hospital. The response rate was 79%. Nurses and other staff reassigned to work in the ICU had higher levels of burnout. Working in Personal Protective Equipment was most distressing, followed by direct patient care. There were positive outcomes including learning opportunities, professional development and job satisfaction. The impact of the pandemic on staff burnout may have been mitigated by acknowledging the contribution of staff, improving communication and encouraging them to access support.

scholarly journals Three models for the regulation of polygenic scores in reproduction

2021 ◽  
pp. medethics-2020-106588
Author(s):  
Sarah Munday ◽  
Julian Savulescu
Keyword(s):  
Human Genetics ◽  
Ethical Issues ◽  
Well Being ◽  
Embryo Selection ◽  
Risk Scores ◽  
Regulatory Regime ◽  
Polygenic Scores ◽  
The Usa ◽  
The Uk ◽  
The Impact

The past few years have brought significant breakthroughs in understanding human genetics. This knowledge has been used to develop ‘polygenic scores’ (or ‘polygenic risk scores’) which provide probabilistic information about the development of polygenic conditions such as diabetes or schizophrenia. They are already being used in reproduction to select for embryos at lower risk of developing disease. Currently, the use of polygenic scores for embryo selection is subject to existing regulations concerning embryo testing and selection. Existing regulatory approaches include ‘disease-based' models which limit embryo selection to avoiding disease characteristics (employed in various formats in Australia, the UK, Italy, Switzerland and France, among others), and 'laissez-faire' or 'libertarian' models, under which embryo testing and selection remain unregulated (as in the USA). We introduce a novel 'Welfarist Model' which limits embryo selection according to the impact of the predicted trait on well-being. We compare the strengths and weaknesses of each model as a way of regulating polygenic scores. Polygenic scores create the potential for existing embryo selection technologies to be used to select for a wider range of predicted genetically influenced characteristics including continuous traits. Indeed, polygenic scores exist to predict future intelligence, and there have been suggestions that they will be used to make predictions within the normal range in the USA in embryo selection. We examine how these three models would apply to the prediction of non-disease traits such as intelligence. The genetics of intelligence remains controversial both scientifically and ethically. This paper does not attempt to resolve these issues. However, as with many biomedical advances, an effective regulatory regime must be in place as soon as the technology is available. If there is no regulation in place, then the market effectively decides ethical issues.

scholarly journals The COVID-19 Pandemic and nursing challenges: A review of the early literature

Work ◽  
2021 ◽  
pp. 1-14
Author(s):  
Mojtaba K. Danesh ◽  
Ehsan Garosi ◽  
Hamedeh Golmohamadpour
Keyword(s):  
Health Systems ◽  
Personal Protective Equipment ◽  
Qualitative Studies ◽  
Systematic Search ◽  
Current Paper ◽  
Protective Equipment ◽  
Early Literature ◽  
The Face ◽  
Physical Distress ◽  
The Impact

BACKGROUND: The COVID-19 pandemic has put health systems under unprecedented pressure, challenging their workforce, especially nurses. OBJECTIVE: The current paper presented a review of the early literature concerning emerging nursing challenges during the early stages of the COVID-19 pandemic. METHODS: A systematic search of the published literature between January and May 2020 was carried out in Medline, Science Direct, and Google Scholar to identify relevant quantitative and qualitative studies. RESULTS: Twenty-two original articles were retrieved, the majority of which were survey studies from China. Synthesis of the evidence resulted in four overarching themes including “being physically and mentally drained in the face of fear and uncertainty,” “shortage of personal protective equipment and usability issues,” “psychosomatic disturbances among nurses,” and “moderators to mitigate nurses’ challenges.” CONCLUSIONS: Providing care for demanding COVID-19 patients, nurses experienced a gruelling situation, during which a significant amount of psychological and physical distress was inflicted to them. However, receiving proper support from their organization and society could improve the condition substantially. Further research is required to explore the impact of the COVID-19 pandemic on nurses, especially from Western countries.

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