PLD Article 10. Burden of proof

It is necessary to alleviate the claimant’s burden of proof provided that certain conditions are fulfilled. Rebuttable presumptions of fact are a common mechanism for alleviating a claimant’s evidential difficulties and allowing a court to base the existence of defectiveness or of a causal link on the presence of another fact that has been proven while preserving the rights of the defendant. In order to provide an incentive to comply with the obligation to disclose information, national courts should presume the defectiveness of a product where a defendant fails to comply with such an obligation. Many mandatory safety requirements have been adopted in order to protect consumers and other natural persons from the risk of harm, including under Regulation (EU) 2023/988. In order to reinforce the close relationship between product safety rules and liability rules, non-compliance with such requirements should also result in a presumption of defectiveness. That includes cases in which a product is not equipped with the means to log information about the operation of the product as required under Union or national law. The same should apply in the case of obvious malfunction, such as a glass bottle that explodes in the course of reasonably foreseeable use, since it is unnecessarily burdensome to require a claimant to prove defectiveness when the circumstances are such that its existence is undisputed. Reasonably foreseeable use covers the use for which a product is intended in accordance with the information provided by the manufacturer or economic operator placing it on the market, the ordinary use as determined by the design and construction of the product, and use which can be reasonably foreseen where such use could result from lawful and readily predictable human behaviour.

Where it has been established that a product is defective and the kind of damage that occurred is, based primarily on similar cases, typically caused by the defectiveness in question, the claimant should not be required to prove the causal link and its existence should be presumed.

National courts should presume the defectiveness of a product or the causal link between the damage and the defectiveness, or both, where, notwithstanding the defendant’s disclosure of information, it would be excessively difficult for the claimant, in particular due to the technical or scientific complexity of the case, to prove the defectiveness or the causal link, or both. They should do so taking into account all the circumstances of the case. In such cases, imposing the usual standard of proof as required under national law, which often calls for a high degree of probability, would undermine the effectiveness of the right to compensation. Therefore, given that manufacturers have expert knowledge and are better informed than the injured person, and in order to maintain a fair apportionment of risk while avoiding a reversal of the burden of proof, that claimant should be required to demonstrate, where the claimant’s difficulties relate to proving defectiveness, only that it is likely that the product was defective, or, where the claimant’s difficulties relate to proving the causal link, only that the defectiveness of the product is a likely cause of the damage. Technical or scientific complexity should be determined by national courts on a case-by-case basis, taking into account various factors. Those factors should include the complex nature of the product, such as an innovative medical device; the complex nature of the technology used, such as machine learning; the complex nature of the information and data to be analysed by the claimant; and the complex nature of the causal link, such as a link between a pharmaceutical or food product and the onset of a health condition or a link that, in order to be proven, would require the claimant to explain the inner workings of an AI system. The assessment of excessive difficulties should also be made by national courts on a case-by-case basis. While a claimant should provide arguments to demonstrate excessive difficulties, proof of such difficulties should not be required. For example, in a claim concerning an AI system, the claimant should, for the court to decide that excessive difficulties exist, neither be required to explain the AI system’s specific characteristics nor how those characteristics make it harder to establish the causal link. The defendant should have the possibility of contesting all elements of the claim, including the existence of excessive difficulties.