Product Liability Directive (PLD)

(48) 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.