On December 8, 2024, the Directive (EU) 2024/2853 on Liability for Defective Products (the so-called “Revised Product Liability Directive”) came into force, ushering in a major update to the Product Liability Directive that had been in place since 1985. The aim of the Revised Directive is to provide broader protection for consumers and users of the EU, adapting the regulation of defective products to the recent changes in the economic, technological and legal environment, as well as to new forms of production, distribution and consumption. The revised framework introduces significant changes that affect the vast majority of economic operators that commercialize products within the EU.
Revised regulation of the burden of proof
One of the most significant changes introduced by the Revised Directive is in Article 10, regarding the burden of proof. This provision sets out a revised framework for proving damage caused by defective products, along with a series of presumptions in favor of the claimant, designed to protect consumers.
The previous Directive 85/374/EEC simply stated in Article 4 that the claimant needed to prove the damage, the defect, and the causal link between the defect and the damage. However, this regulation was widely considered to be one of the weak points identified in the liability regime which needed to be addressed in order to ensure the effectiveness of the system. This is due to the fact that, in practice, proving that a product is defective or establishing the causal link between the defect and the damage is a particularly difficult task for the aggrieved party, especially in the current digital age, where products are becoming increasingly complex due to digitalization and the interconnection of components and other services. As a result, the Revised Directive introduces a new mechanism designed to make it easier for consumers to claim compensation for damage caused by defective products.
While the Revised Directive builds on the foundation of the previous one, maintaining the basic principle that the claimant bears the burden of proof, it does introduce certain procedural advantages in favor of the claimant. These advantages are implemented through a series of presumptions that can be classified into three different kinds:
As we can see, the presumption outlined in Article 10.2 (a), which provides that the product is presumed to be defective when the defendant fails to disclose the requested pertinent evidence, is the one expected to generate the most impact, as it seems to establish a sort of reversal of the burden of proof. This could potentially cause significant harm to economic operators, as it would shift the burden of proof to the defendant, requiring them to demonstrate that the product was not defective or that any defect present did not cause the damage. This could pose significant challenges, particularly in complex situations where multiple parties are involved, each with potentially conflicting claims or evidence. In these scenarios, the defendant may struggle to present a clear and convincing defence, especially when trying to disentangle the various factors contributing to the damage.
The position in Spain
The challenges that will arise become even more evident when we take into consideration that the regulation of the burden of proof under the previous Directive 85/374/EEC, which was transposed into Spanish law through Article 139 of the Consolidated Text of the General Law for the Defense of Consumers and Users, already made it difficult for producers to counter the claims made against them. The previous approach implied that, in order to obtain compensation, ‘the victim must only prove the existence of the damage and that it has been caused by a defective product’ (Judgment nº 293/2020 of the Court of Appeals of A Coruña, dated 20 October of 2020). Additionally, the Courts established that ‘the injured party must prove that the product is defective, but not that this defect was caused by the manufacturer’ (Judgment nº 585/2023 of the Court of Appeals of Les Illes Balears, dated 13 December of 2023), creating a system of liability ‘which is objective and unrelated to the concept of fault’ (Judgment nº 93/2022 of the Court of Appeals of A Coruña, dated 22 March of 2022), meaning that it was not necessary to prove the producer's fault or negligence in order to establish their liability. Therefore, if the previous framework already made it difficult for producers to defend themselves against claims from injured parties, the Revised Directive, by introducing a series of presumptions in favour of consumers, will create even greater difficulties for these economic operators.
However, some legal experts have chosen to take a more critical point of view with respect to these presumptions, as they suggest that some of them are not strong enough to make a significant impact in the market and that the claimant is still required to prove their claim. For instance, they argue that the presumption in Article 10.2 (b), which requires the claimant to demonstrate that the product breaches mandatory safety requirements meant to prevent precisely the type of damage experienced is, in fact, very similar to requiring direct proof of the defect itself. A similar issue arises with the presumption set out in Article 10.4, as it requires the claimant to show that it is likely the product is defective and that there is a causal link between the defect and the damage. Although, in this case, proof is particularly challenging for the claimant because, even though irrefutable proof is not required, Courts demand a reasonable level of evidence to establish a causal link between the damage and the defect. This can be seen in the Judgment nº 602/2021 of the Court of Appeals of Barcelona, dated 9 November of 2021, in which the Tribunal sets a demanding standard of proof by requiring that the causal link be proven clearly and ‘conclusively’, without basing the claim on ‘probability judgments’.
Additionally, it is important to note that, while the Revised Directive might create certain difficulties for economic operators, it does not leave them completely unprotected, as it allows for any of these presumptions to be rebutted by the defendant. While some of the presumptions do not appear to significantly shift the burden of proof onto the defendant, others, such as the one outlined in Article 10.2 (a), do seem to introduce substantial changes to the current position. In this regard, even though the EU Commission maintains that the burden of proof remains on the claimant and has not been reversed, it is easy to imagine situations where some of the new provisions could result in a shift of the burden to the defendant. In such cases, the defendant would have to prove that the product was not defective or that the defect did not cause the damage, which could be particularly challenging in complex cases, such as those involving multiple parties in conflict.
Effects on economic operators
As we have seen, the Revised Directive, and particularly the new provisions concerning the burden of proof, will be especially detrimental to all economic operators distributing products across the EU, as they will make it harder for them to defend themselves against claims for damages caused by defective products. In addition, the Revised PLD broadens the scope of businesses included within the term 'economic operators' and therefore those who will be liable under the new regime. The previous PLD limited liability for any damage caused by defective products to producers (including the manufacturer or the importer of the product into the EU), however, the revised framework now holds additional parties accountable, such as manufacturers of defective products or components integrated into or interconnected with the products (including any individual who substantially modifies a product outside the manufacturer's control and subsequently makes it available on the market or puts it into service). Moreover, the Revised Directive goes a step further by ensuring that if any of these liable entities are based outside the EU, consumers can still seek compensation (without prejudice to the manufacturer's liability) against the importer who places the product from a third country on the EU market, but also the manufacturer's authorised representative, or the fulfillment service provider.
In practical terms, the changes introduced by the Revised Directive are expected to lead to an increase in claims, especially in industries where products reach consumers at the end of the supply chain, as well as industries importing products from manufacturers based outside the EU. This includes sectors such as consumer goods, pharmaceuticals, medical products, automotive, and software. All economic operators involved in the production, distribution, and supply of products and related services including not only physical goods, but also raw materials and standalone software (such as artificial intelligence software), as well as online platform providers, will be affected by the changes posed by the Revised PLD.
The Revised PLD brings about significant changes that will apply to all products placed on the market or put into service after December 9, 2026. Member States have until this date to integrate the Directive into their national laws, addressing important aspects such as compensation calculations and procedural rules. It will be necessary to wait for the transposition of this revised regulation to see how the burden of proof will be articulated in the national legal systems. What is clear, however, is that to ensure consistent protection across the EU, Member States must carefully implement the articles of the Revised Directive as the legislation does not allow deviations from its provisions regarding the burden of proof.
As national lawmakers continue to work on codifying the text of the Revised Directive, all economic operators within the EU should start preparing for the changes that it poses. They must act swiftly, taking full advantage of the remaining time before the final transposition in order to make the necessary efforts to comply with the stricter obligations and responsibilities imposed by the Revised PLD.
Furthermore, the insurance sector also faces important challenges, including responding to the potential increase in claims relating to defective products. Therefore, insurers will need to review and adjust their policies to cover the new risks associated with digital and technological products, as well as to adapt to the new changes, which will likely involve modifying premiums, redefining exclusions, and reassessing coverage capacity.
With thanks to Adriana Fernandez Olvia for help with producing this article.
This article is part of a larger series of articles on the new RPLD which include: