 in this context. However, it must still be the case that the requirements of product safety regulations are an important consideration when trying to assess what a person's legitimate expectations as to safety are for the purposes of liability under the PLD. This is an area ripe for further consideration in Europe.
Additionally, breach of regulatory obligations can give rise to its own liability, which can sometimes result in criminal sanctions (including fines and imprisonment) against individuals of defendant companies.
National laws of the jurisdiction in which product liability claims are brought will determine the relevant rules for payment of costs.
Applicable rules for litigation funding are those of the member state in which the product liability claim is brought.
Historically, collective redress mechanisms in the EU were governed at member state level. Since 2013, the European Commission had been calling for the use of such mechanisms by all member states, but not all countries had adopted this recommendation.
Currently, however, as part of the so-called New Deal for Consumers, an EU-wide mechanism is being considered for collective redress, which, if implemented, is likely to change the way in which product liability claims are brought across Europe, particularly for those countries that had not previously used a collective redress mechanism locally. (See 3.1 Trends in Product Liability and Product Safety Policy and 3.2 Future Policy in Product Liability and Product Safety).
Product liability law cases which interpret the PLD have historically been relatively infrequent in the EU.
However, recent case law from the CJEU in respect of the PLD has arisen in the context of medical device litigation in the EU. Two seminal recent cases include Boston Scientific Medizintechnik GmbH v AOK Sachsen-Anhalt Die Gesundheitskasse (C-503/13), in which the court considered the meaning of "defect" under the PLD, and N W v Sanofi Pasteur MSD SNC (C-621/15), in which the court considered the requirement for the claimant to prove a causal link under the PLD.
The Boston Scientific case introduced the concept of "batch liability" by finding that a determination that a particular device was defective could, in certain circumstances, be extended to conclude that all suitably similar devices were similarly defective. In the case, the health insurer of a surgical group brought a claim against the manufacturer of implantable cardioverter defibrillators and pacemaker devices for the cost of replacement of devices with significantly elevated failure rates. The CJEU relied on the high failure rate to establish that any product in the group was defective, and that all costs associated with their replacement were therefore recoverable. The court stated that persons are entitled to expect "particularly high" safety requirements for the specific types of products in question because of the "particularly vulnerable situation” the implant creates. The court did not provide guidance as to the application of this principle outside these narrow factual circumstances, and in particular to other types of products.
In the Sanofi case, the CJEU confirmed the broad tools that the claimant may employ in establishing causation under the PLD. The family of a deceased man alleged that a vaccine for hepatitis caused the multiple sclerosis which ultimately resulted in his death. French courts had previously allowed the claimant to establish causation under French law by "evidentiary presumptions" – ie, there was no pre-existing family history of the disease and the disease arose shortly after the vaccine was administered. In upholding the French court’s acceptance of the claimant’s causation evidence, notwithstanding a lack of scientific proof to establish a link between the vaccine and the disease, the CJEU stated that national courts have a wide discretion to determine what evidence a claimant can rely on to prove causation, as long as the evidential burden of proof is not reversed.
Although there is variance between member states, product liability risk is generally on the rise and the volume and complexity of litigation is increasing.
The EU product safety regime, itself, has recently undergone significant and comprehensive reform.
First, there have been several initiatives introduced across the EU that are aimed at (i) further harmonising national approaches to enforcement of product safety laws, in light of widely divergent enforcement practices by national authorities, and (ii) re-emphasising the spirit of EU product safety legislation and its focus on free circulation within the single market, as based on the Treaty on the Functioning of the European Union that underpins EU law generally.
The "Goods Package", which involves two distinct Regulations, addresses the above-mentioned two core EU product safety law principles whilst seeking to achieve fairer market conditions for product suppliers operating in the EU, albeit with the increased risk of costs associated with compliance and of falling foul of enforcement powers.
the establishment of “product contact points” in each member state, which provide free advice to business to assist in interpreting mutual recognition regulations.
the introduction of additional mechanisms for communication flow between market surveillance and custom authorities in respect of non-compliant products.
the Price Indication Directive (98/6/EC).
monitors price reduction claims.
A Directive on collective redress is currently proposed (see 3.2 Future Policy in Product Liability and Product Safety for further discussion).
Implicit to the above initiatives is the modernising of the legislation taking into account technological advances, which has been a well-worn theme in EU product safety legislative developments for several years now. Specific reform aimed at making older legislation "fit for purpose" in a modern world, the facilitation of interconnectedness and digital transformation across the Union and the targeting of online platforms and sales have also been the focus of EU policy-makers.
Directive (EU) 2019/771 on certain aspects concerning contracts for the sale of goods, which repeals the existing Consumer Sales and Guarantees Directive 1999/44/EC (CSGD), is designed to enhance and harmonise European consumers’ contractual rights, which have historically been divergent across the EU, in respect of non-functional products and with a new focus on products with digital elements. Specifically, under the new regime for goods with digital elements, liability and the burden of proof remain with the seller for two years. The legislation is aimed at “levelling the playing field” to allow smaller business to operate alongside “e-commerce giants”.
the requirement that businesses provide updates to consumers throughout the period of supply.
The above-mentioned Regulation (EU) 2019/1020 on market surveillance and compliance of products, part of the new Goods Package will also necessarily have an impact on online sales.
Legislators have also looked at the impact of the product industry more broadly, focusing on and developing a set of laws that increase the consumer products industry’s social responsibility and social impact. Some of the major legislative initiatives in this area are set out below.
The new Directive on Accessibility Requirements for Products and Services (also known as the European Accessibility Act (EAA)) is aimed at improving access to products and services for those with disabilities or other functional impairments, as part of the European Disability Strategy 2010-2020. The EEA establishes common accessibility requirements for the user interfaces of specific products and services (phones, computers, tablets, e-books, payment terminals, consumer banking, audio-visual media services and e-commerce).
certain information must be made available to professional repairers and a list of the spare parts and the procedure for ordering them must be displayed on a free access website by the manufacturer, distributor or authorised representative.
Much of the new legislation discussed in 3.1 Trends in Product Liability and Product Safety Policy is yet to be implemented, such that its impact is still to be felt in full. The timeline for implementation of these many and varied legislative initiatives is set out below.
The legislation for the reform of the sale of goods legislation, namely Directive (EU) 2019/771 on certain aspects concerning contracts for the sale of goods, and also Directive (EU) 2019/770 on certain aspects concerning contracts for the supply of digital content and digital services, came into effect on 11 June 2019. Member states now have until 1 July 2021 to transpose these laws into national law. Member states have until 1 January 2022 to apply their local implementation of these legal requirements.
Directive (EU) 2019/2161 on the better enforcement and modernisation of Union consumer protection rules, one part of the Goods Package, came into force on 7 January 2020. The Directive must be implemented into national law by member states by 28 November 2021. That national legislation must have effect from 28 May 2022.
The initiatives under the Ecodesign Directive (2009/125/EC) were adopted on 1 October 2019 and will apply from 1 March 2021 (for most affected product groups).
There are also several further legislative initiatives still being finalised, and which are at varying stages in the legislative process, that are relevant to the initiatives discussed in 3.1 Trends in Product Liability and Product Safety Policy.
As part of the New Deal for Consumers a proposed Directive on representative action will allow certain consumer organisations (qualified entities) to bring a representative action seeking compensation, repair or replacement in respect of a defective product on behalf of a large class of consumers. Member states will decide whether such collective actions are opt-in or opt-out. The legislation currently proposes a "loser pay principle" whereby the losing party will be required to cover the cost of the winner. There is also discussion of further refining the distinction between domestic and EU-wide representative actions in further iterations of the document. Following debate over various aspects of the draft legislation (the Directive), including suggestions made by the European Parliament’s Committee on the International Market and Consumer Protection in 2019, the European Parliament adopted an amended version of the Directive, in late 2019. Currently, the Directive on representative actions remains under negotiation.
More broadly, under the European Green Deal, the EC has committed to becoming carbon neutral by