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Rebuttable presumptions of fact under the EU Commission’s recent product liability directive proposal

23 December 2022

Injured parties have claimed for a long time that one of the biggest obstacles they face to obtain compensation for damages suffered in product liability cases, is to meet the burden of proof regarding the defectiveness of the product and the causal link between the alleged defect and the damages suffered. This will likely continue to remain the main battlefield in future product liability cases.

Under the currently applicable Product liability Directive it is the injured person that has to prove the damage, the defect in a product and the causal relationship between the defect and the damage. Even if this basic allocation of the burden of proof will – as a principle – not be modified by the European Commission’s recent Proposal for a Directive of the Parliament and of the Council on liability of defective products (“PLD Proposal”)¹, the new provisions of the PLD Proposal may very well change the situation in practice.

The European Commission has indeed highlighted that such allocation of the burden of proof has led and may lead to an unequal relation between the parties involved. One of the aims of the PLD Proposal is to reduce this inequality, by – amongst other things – expanding the concept of “defect” and introducing rebuttable presumptions of defectiveness and of causation.

Expansion of the concept of product defect

The currently applicable Product liability Directive stipulates that a product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account, including:

the presentation of the product;
the use to which it could be reasonably be expected that the product would be put; and
the time when the product was put into circulation.

Under the PLD Proposal the concept of “defect” is greatly expanded. Especially additional circumstances that need to be taken into account when assessing whether the product is defective are defined by Article 6 of the PLD Proposal. It stipulates that a product shall be considered defective when it does not provide the safety “which the public at large is entitled to expect”, taking all circumstances into account, including the following:

the presentation of the product, including the instructions for installation, use and maintenance;
the reasonably foreseeable use and misuse of the product;
the effect on the product of any ability to continue to learn after deployment;
the effect on the product of other products that can reasonably be expected to be used together with the product;
the moment in time when the product was placed on the market or put into service or, where the manufacturer retains control over the product after that moment, the moment in time when the product left the control of the manufacturer;
product safety requirements, including safety-relevant cybersecurity requirements;
any intervention by a regulatory authority or by an economic operator referred to in Article 7 relating to product safety; and
the specific expectations of the end-users for whom the product is intended.

The assessment of defectiveness should involve an objective analysis and therefore refer to the safety that the public at large is entitled to expect. Relevant factors to assess whether a product is objectively safe are, inter alia, the intended purpose, the objective characteristics and the properties of the product in question as well as the specific requirements of the group of users for whom the product is intended.² The notion of “public at large” will probably raise interpretation issues in the EU Member states. For instance, can we no longer expect more discernment and precaution from a professional claimant than from a simple consumer? Conversely, if we take the example of medicinal products, even if the provisions refer to the ”specific requirements of the group of users for whom the product is intended”, the notion of “public at large” implies that the alleged defect of a medicine could no longer be assessed in light of the specific health condition of an individual patient. In other words, the benefit/risk ratio would only be assessed for the general population, which makes sense to us, and not with regards to claimants individually contrary to what some national courts may have ruled in the past.

Alleviation of the burden of proof

As highlighted by the European Commission, experience with the current Product Liability Directive has shown that it is not always easy for the injured party to prove that a product is defective and/or to prove the causal link between the alleged product defect and the damages suffered.³ It is with this in mind that the EU legislator notably introduced disclosure of evidence rules to the benefit of claimants in Article 8 of the PLD Proposal.⁴

For the EU legislator, the aim of the PLD Proposal is to more fairly share the burden of proof between injured parties and manufacturers. To that end, the PLD Proposal is building on a long line of case law under the existing PLD by national courts and the ECJ with the aim to increase legal certainty and ensure, to the extent possible, a coherent implementation of product liability rules throughout the EU.

Accordingly, the EU Commission proposed to introduce various rebuttable presumptions both for the defectiveness of the product as well as for the causal link between its defectiveness and the damage.

Presumptions of defectiveness

The PLD Proposal introduces in its Article 9 a total of four rebuttable presumptions for the defectiveness of the product.

Firstly, if a defendant does not comply with its obligation to disclose relevant information at its disposal⁵, the national court shall presume that the product is defective.⁶

Secondly, the defectiveness of the product shall be presumed where the claimant establishes that:

the product does not comply with mandatory safety requirements laid down in Union law or national law, and
the respective requirements are intended to protect against the risk of the damage that has occurred in the individual case.⁷

Moreover, the defectiveness of the product shall be presumed where the claimant establishes that:

the damage was caused by an obvious malfunction of the product, and
it occurred during normal use or under ordinary circumstances.⁸

Finally, the defectiveness of the product shall be presumed where:

a national court judges that the claimant faces excessive difficulties, due to the technical or scientific complexity, to prove the product defect, and
the claimant has demonstrated, on the basis of sufficiently relevant evidence, that the product contributed to the damage, and
the claimant has demonstrated, on the basis of sufficiently relevant evidence, that it is likely that the product was defective.

Rebuttable presumptions of defect
1	A defendant does not comply with its obligation to disclose relevant information at its disposal
OR
2	The product does not comply with mandatory safety requirements laid down in Union law or national law			AND	The respective requirements are intended to protect against the risk of the damage that has occurred in the individual case
OR
3	The damage was caused by an obvious malfunction of the product			AND	It occurred during normal use or under ordinary circumstances
OR
4	A national court judges that the claimant faces excessive difficulties, due to the technical or scientific complexity, to prove the product defect	AND	The claimant has demonstrated, on the basis of sufficiently relevant evidence, that the product contributed to the damage			AND	The claimant has demonstrated, on the basis of sufficiently relevant evidence, that it is likely that the product was defective

Presumptions of causation

In addition to the presumptions of defectiveness, Article 9 of the PLD Proposal also introduces two rebuttable presumptions for the causal link between the alleged defectiveness of the product and the damage.

Firstly, the causal link between the defectiveness of the product and the damage shall be presumed where the claimant establishes that:

the product is defective, and
the damage caused is of a kind typically consistent with the defect in question.⁹

Secondly – and this presumption is analogous to the fourth one concerning the defect – the causal link between the defectiveness of the product and the damage shall be presumed where:

a national court judges that the claimant faces excessive difficulties, due to the technical or scientific complexity, to prove the causal link between the defectiveness of the product and the damage, and
the claimant has demonstrated, on the basis of sufficiently relevant evidence, that the product contributed to the damage, and
the claimant has demonstrated, on the basis of sufficiently relevant evidence, that the product’s defectiveness is a likely cause of the damage.

Rebuttable presumptions of causation
1	The product is defective			AND	The damage caused is of a kind typically consistent with the defect in question
OR
2	A national court judges that the claimant faces excessive difficulties, due to the technical or scientific complexity, to prove the product defect	AND	the claimant has demonstrated, on the basis of sufficiently relevant evidence, that the product contributed to the damage			AND	The claimant has demonstrated, on the basis of sufficiently relevant evidence, that it is likely that the product was defective

This presumption will be of particular concern to manufacturers of pharmaceuticals and advanced technology. The European Commission emphasizes that technical or scientific complexity will have to be assessed by the national court on a case-by-case basis. A number of factors are relevant in that regard, including: the complex nature of the product or technology used; the complexity of the information and data the injured party has to analyse; and the complex nature of the causal link. The excessiveness of the difficulty will have to be argued by the injured party, but the proof thereof should not be required of them. However, the defendant should in any case be given the opportunity to challenge the existence of the argued excessive difficulties.

Rebutting the presumptions under the PLD Proposal

The presumptions referred to in the above do not reverse the burden of proof, which remains, at least on the paper, on the injured party both for the defectiveness of the product as for the causal link between the defectiveness of the product and the damage. The European Commission emphasized this in so many words in the Explanatory Memorandum to the PLD Proposal by stating “[…] However, there will be no reversal of the burden of proof, as this would expose manufacturers to significantly higher liability risks and could hamper innovation, leading also to potentially higher product prices and reduced access to innovative products.”¹⁰

In any case the defendant shall have the right to rebut any of the abovementioned presumptions under Article 9 Para 5 PLD Proposal.

To rebut the alleged product defect presumed by the national court, the defendant shall demonstrate that the facts established as prerequisites for the national court to presume the defectiveness of the product do not make the product defective according to Article 6 PLD Proposal. This means that the defendant must show that the product does provide the safety the public at large is entitled to expect in this regard.

To rebut the alleged causal link presumed by the national court, the defendant shall demonstrate that the product defect did not cause the alleged damage. This means that the defendant must show either that the damage could not have been caused by the product defect or that the damage was caused by other circumstances than the product defect.

Although the EU Commission opines that rebuttable presumptions of fact are a common mechanism for alleviating a claimant’s evidential difficulties and that in order to facilitate harmonised interpretation of this PLD Proposal by national courts, Member States should be required to publish relevant court judgments on product liability (Article 15 PLD Proposal), the concrete operation of the presumptions and their rebuttal in national court cases will largely depend on the corresponding Member State’s rules of civil procedure, in particular evidentiary rules including standard and means of proof, as applied by its national courts, which are not harmonised by the PLD Proposal.

Conclusion

The PLD Proposal is far from being final and is at an early stage of legislative work despite the numerous stakeholder consultations, impact assessments and discussions surrounding a revision of the PLD that have taken place these past years.

Both the European Parliament and the Council will review the PLD Proposal and suggest amendments. Without a crystal ball it is not possible to predict when the trilogue process will conclude, even if on average such process takes around two years. It is thus possible that the new PLD will be enacted before the end of the term of the current European Parliament in 2024.

Moreover, once the PLD is finalized at Union level, transposition of the novel mechanisms included in the PLD Proposal – which are likely to comprise all or some of the new rebuttable presumptions of fact – into the respective national no-fault liability systems of the Member States will raise additional and important legal issues – both of substantive and of procedural law.

Anyhow, the new proposed regime regarding the presumptions of defectiveness and causal link is likely to have a significant impact on manufacturers of all kinds of products and potentially could lead to more product liability proceedings, not to mention forum shopping strategy for proceedings aiming at having manufacturers’ evidence disclosed. It is fair to say that in many Members States the implementation into national law of the above-described mechanisms would represent a significant procedural change. And, in the first years of their application, these novel mechanisms may likely result in less legal certainty and less harmonisation of product liability law then today. Open questions include what will be the impact of the new set of rules on the already established case law under the existing PLD and what will happen to the presumptions of defect and/or causation that may already have been established by Member States’ case law, once the new legal presumptions come into effect?

Instead of significantly alleviating the injured parties’ difficulties in proving the defendant’s liability, the PLD proposal may well result in merely shifting the battle from a fight for proof of defect and proof of causation to a fight for application and rebuttal of the corresponding presumptions.

Hogan Lovells is actively monitoring developments in this space – keep an eye out for our future updates. For former articles of Hogan Lovells’ European Product liability team please head to the Products Law Engage page.

Authored by Ina Brock, Nicole Saurin, Benjamin Schulte, Karen Jelsma, Mahsa Amiri Bavandpour, and Charles-Henri Caron.