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The adoption of the strict liability scheme for defective products by the European Union Product Liability Directive, and its subsequent transposition through Pt 1 of the Consumer Protection Act 1987, changed the basis on which actions for compensation for damage caused by defective products had been brought for over fifty years. In essence, the change was from a system which required proof of negligence to one in which liability was dependent on proving that a defective product had caused damage. While we shall see that many academics and commentators had originally assumed a critical view of the strict liability regime, considering that in practice liability would be no wider than under negligence, it is now clearly established that, in respect of products supplied on or after 1 March 1988, strict liability under the 1987 Act is the primary cause of action in product liability litigation in the United Kingdom. In many Member States, the effects of the new regime have been very significant indeed.

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.

The conflict of laws is one of the names given to the subject that deals with the resolution of private law disputes between private law parties where the facts have a connection to more than one legal system. Such situations arise frequently in product liability. For example, a product is assembled in State A using different components manufactured in States B, C, and D. Alternatively, a product is manufactured in State A, placed upon the market in State B, and consumed by the purchaser in State C, causing him injury which requires treatment in State D. In product liability litigation the fact that there are foreign issues means that a lawyer presented with such a case by the claimant must consider additionally three basic and interrelated questions. First, can the desired court hear the case the claimant would present to it? This is the jurisdiction question. If the answer is ‘No’, the claimant’s case will not proceed in that forum but may be able to be presented in another forum. If the answer is ‘Yes’, this means that the rules of jurisdiction may allow the claimant’s case to proceed as desired. The question of jurisdiction has a general and a specific aspect: the court must have the jurisdiction to hear the claim considered both in a general sense and in the specific sense involving the specific parties that the claimant would involve in the litigation he hopes to conduct before it.

The global war against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), and the disease it causes (Covid-19), is being fought by many countries on many fronts. Equipment is essential in any war , and it is no different where that equipment takes the form of medical supplies. Faced with the current pandemic, a vast global demand has arisen for an array of products, from test kits and chemicals, personal protective equipment (PPE), hand sanitisers and other biocidal products, ventilators and similar devices, as well as medicines, treatments and (of course) a vaccine. Producers are now scrambling to meet that demand by ramping up production, developing modified and new products at astonishing speeds, as well as manufacturing in novel ways. So what of the legal considerations? In this piece we explore from a legal perspective some of the issues that might arise, and how existing legal concepts might respond. Our purpose is not to erect legal road blocks in the way of meeting demand for essential healthcare products; quite the contrary. It is to contribute to the consideration of the application of laws covering product liability and regulation an early stage, when ex ante measures (such as providing warnings, obtaining indemnities from government etc) are still available to producers and lawmakers.

INCEPTION OF THE PRODUCT LIABILITY DIRECTIVE HISTORICAL BACKGROUND From a historical perspective, product liability was traditionally seen in many jurisdictions as merely a concrete illustration of the law of obligations to a specific factual matrix, involving the causing of damage by a product. It was only when the mass manufacture of consumer goods started to occur that sufficient impetus was generated towards the identification of an autonomous area of law. It was only then that practitioners and scholars commenced specialisation in the sphere of product liability. The US was of course at the vanguard of developments, and a word will thus be said of the evolution in the US, as a background to the European context. Professor David Owen records in his leading US treatise on the topic that the consequence of the spread of industrialisation in the 19 th century was that by 1900, products ‘cases began to appear with some frequency’. There then followed iconic cases such as MacPherson v Buick Motor Co or Greenman v Yuba Power Products Inc, which ushered in the modern era of US products liability, accompanied by the various Restatements, with Owen noting that the strict liability rule enshrined in §402A of the Restatement (Second) of Torts resulted in the ‘the doctrine of strict products liability in tort, together with a miscellany of secondary principles spread like wildfire around the nation’. The development of product liability in Europe as a distinctive area of the law occurred much later than in the US. It was not until relatively late in the 20 th century, after the occurrence of mass product disasters in Europe, and the realisation that traditional responses of the law were inadequate to deal with such situations, that there was a movement towards products liability as raising distinct legal issues, for which a tailor-made regime for compensation was potentially required. It should be noted that comparative law played a role in this process in certain European jurisdictions, with Gerhard Wagner describing for instance how in Germany ‘product liability was imported from the US, both with regard to the legal problem and its solution’.

International audience

The Product Liability Directive was adopted in 1985. Despite ample evidence of uncertainty as to the meaning of some key provisions, there is no sign that the Commission is keen to engage in a revision of the Directive. Our intention in this article is not to prescribe substantive solutions but to consider how, methodologically, reform might be achieved. Whilst some potential reforms, such as the removal of the ten year long-stop, may require legislative intervention we consider if there is any scope for making the law more certain with developments based on alternative ‘soft law’ techniques for promoting greater certainty. We conclude that Guidance may be helpful, but should be founded on a minor amendment to the Directive authorising such Guidance to be developed.

The paper uses the opportunity afforded by the European Commission's Third Report of the Product Liability Directive to assess the present state of product liability in Europe. It notes that despite the maximal harmonisation character of the Directive there is a risk of divergence between Member States on key issues including the core concept of defectiveness. The Commission seems at times confused (for example, as regards the relationship between defect and fault liability) and more often complacent about the risks of divergence; but this sits uneasily with the espousal of maximal harmonisation. Ultimately there may be a need for a rethinking of product liability to ensure greater clarity as regards the underlying rationale supporting strict liability. This seems unlikely to materialise in the near future and so at the very least the Commission should act to clarify some core concepts that are proving difficult to interpret for the courts.

PurposeAlmost 20 years ago one of the present authors wrote an article entitled “Product liability: a global problem”. The brief paper seeks to provide a summation of what has happened in the meantime.Design/methodology/approachThe article is a brief discussion of the issues: the first section comments on products liability outside Europe and the final part concludes with an overview of what happened in the UK and Europe.FindingsThe article finds that the EU Directive's approach to strict liability has become the most common influence on law reform around the globe and that there is still much uncertainty in Europe and the USA as to what the law of product liability actually is.Originality/valueThe paper illustrates how, for the foreseeable future, businesses may continue to be most concerned about product liability exposure in the USA.

Introduction The preamble to the 1985 European Directive on Product Liability declares that harmonisation of national rules is necessary in view of the fact that disparities are liable to distort competition, to affect the free movement of goods and lead to differences in the level of protection offered to consumers against physical injury and damage to goods caused by a defective product. The interaction between Community law and the national laws of the Member States has been a complex process. The purpose of this paper is to analyse the reception of this aspect of European law in one system, that of France. The French law on product liability has traditionally adopted a pro-consumer approach, engineered mainly by the intervention of the courts. Professor John Bell has noted that the French law of product liability is essentially a creature of judicial and doctrinal interpretation of the Napoleonic Code. Professor Malinvaud has also described how the judiciary have been active in shaping the law: Guided by the desire to compensate as fully as possible the victim, that is to say the consumer of the product, the case law has created a new positive law whilst respecting the texts, at least in appearance. It will be shown in this chapter that following the chronic delay on the part of the French legislator to implement the European Directive, the French courts themselves acted, and moulded the case law in a way inspired by the themes underpinning the European provisions.