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

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 prod...

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Bibliographic Details
Published in:European Journal of Risk Regulation 2020-09, Vol.11 (3), p.565-603
Main Authors: FAIRGRIEVE, Duncan, FELDSCHREIBER, Peter, HOWELLS, Geraint, PILGERSTORFER, Marcus
Format: Article
Language:English
Subjects:
Causality
Clinical trials
Compensation
Coronaviruses
Courts
COVID-19
Disease transmission
Drugs
Emergency preparedness
FDA approval
Infections
Liability
Marketing
Medical equipment
Medical supplies
Pandemics
Production
Products liability
Public health
Regulation
Regulatory agencies
Severe acute respiratory syndrome coronavirus 2
Supply chains
Urgency
Vaccines
Ventilators
Zoonoses
Citations: Items that cite this one
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Summary: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.
ISSN:1867-299X
2190-8249
DOI:10.1017/err.2020.54