Product liability – CJEU clarifies limitation period and ten year extinction of rights

Product liability – CJEU clarifies limitation period and ten year extinction of rights

April 2026
Product liability – CJEU clarifies limitation period and ten year extinction of rights

The Court of Justice of the European Union (“CJEU”) has recently clarified three key issues of the regime governing liability for defective products: the coexistence of the regime laid down in Council Directive 85/374/EEC on liability for defective products (“Directive”) with the general civil liability regime, the validity of the ten year period after which the rights conferred by the Directive are extinguished, and the determination of the starting point of the three year limitation period.

It did so in its judgment of 26 March 2026 (judgment in LF v Sanofi Pasteur SA, C 338/24), in a dispute concerning alleged damage resulting from the administration of a vaccine, which was said to have led to a subsequent progressive disease.

Although the case arises in the specific context of vaccines, the issues now clarified by the CJEU impact product liability litigation in general.

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April 2026
Product liability – CJEU clarifies limitation period and ten year extinction of rights

Decision of the CJEU and departure from the Opinion of the Advocate General

First, the CJEU interpreted Article 13 of the Directive – a provision which states that the regime laid down in the Directive does not affect any rights which an injured person may have under other rules of liability – as meaning that the no fault liability system for defective products does not, in abstract, exclude the possibility for the injured party to bring, in parallel, an action for damages based on the general regime of fault based civil liability, provided that the legal basis is genuinely distinct from the Directive’s concept of “defect” (for example, keeping a product in circulation despite a known defect or failures in pharmacovigilance).

In this respect, the CJEU followed the Opinion of the Advocate General, who also accepted that both regimes may apply where the alleged wrongful act is not confined solely to the lack of safety of the product.

There is, in truth, nothing genuinely new here: the coexistence of the producer’s liability regime with the general regime of civil liability was not seriously in dispute. It is, therefore, merely a confirmation of an understanding already settled in the case law.

The most relevant aspect of the judgment concerns the extinction of rights after ten years and the limitation period.

As regards Article 11 of the Directive – which provides that the rights conferred upon the injured person pursuant to the Directive are extinguished upon the expiry of a period of ten years from the date on which the producer put the product into circulation – the CJEU held that this ten year period is valid and compatible with the right of access to a court enshrined in Article 47 of the Charter of Fundamental Rights.

On this point, the Court did not follow the Opinion of the Advocate General, who had proposed that this period be declared invalid in so far as it may extinguish the rights of victims of progressive diseases who are unable to fully assess the damage within ten years. The CJEU emphasised in this regard that the EU law sought to strike a balance between the protection of injured parties and the need to limit, in temporal terms, the no fault liability system.

In essence, the CJEU underlined the need to ensure a balance between compensation for damage and to safeguard innovation, particularly in a context in which producers are subject to a heavy no fault liability framework. The CJEU nevertheless stressed the possibility for the injured party to avoid the extinction of rights after ten years by bringing proceedings – including declaratory actions – provided that national law lays down effective procedural mechanisms for that purpose. In short, an action brought after that period must be regarded as inadmissible on account of the extinction of the rights conferred by the Directive.

As regards Article 10 of the Directive – which concerns the three year limitation period – the CJEU once more rejected the solution proposed by the Advocate General, namely that this period should start to run only from the “stabilisation” of the damage in cases of progressive disease.

The CJEU made it clear that the limitation period starts to run when the injured party has knowledge, or ought to reasonably have knowledge, cumulatively: (i) of the damage that has definitively become apparent in a clearly identifiable manner in connection with the allegedly defective product, regardless of its subsequent evolution; (ii) of the defect; and (iii) of the identity of the producer. The “stabilisation” criterion is rejected as being indeterminate and likely, in cases of progressive disease, to coincide with the very death of the injured person, which would be incompatible with the requirements of foreseeability and legal certainty which the Directive seeks to guarantee.

Practical implications and interaction with the new Directive on product liability

From a practical standpoint, the judgment is relevant for defective products litigation far beyond the sphere of vaccines.

For producers, the CJEU confirms the central architecture of the regime established by the Directive: a three year limitation period, based on knowledge of the damage, the defect and the producer, and a ten year period, running from when the producer put the product into circulation, following which the rights conferred on the injured person by the Directive are extinct unless proceedings have been initiated in the meantime. This avoids potentially unlimited liability in cases of progressive disease, while at the same time requiring injured parties to use in good time the procedural mechanisms available (including declaratory actions) to safeguard their position.

For injured parties, the message is twofold: on one hand, the protection afforded by the no fault liability system for defective products remains in place, including in the context of progressive disease; and on the other, there is no room to wait indefinitely for clinical “stabilisation” of the condition before taking action. Prudence suggests that proceedings should be brought promptly, bearing in mind that, after the product has been put into circulation, the rights conferred by the Directive will in principle expire after ten years, even though, within that period, claims may be adapted and additional heads of damage quantified as the clinical situation evolves.

Finally, the judgment is also useful in the context of the new Directive (EU) 2024/2853 (“New Directive”) on product liability. Although it was delivered under the Directive and therefore does not address the new rules, the new regime – which applies to products placed on the market or put into service as from 9 December 2026 – maintains the model of a three year limitation period (running from knowledge of the damage, the defect and the producer) and a ten year period (subject, however, to the special case of “substantially modified products”). It nevertheless introduces, for certain cases of personal injury where the “latency” of the damage prevents the bringing of an action within that period, an extended period of twenty-five years.

The transposition of the New Directive into national law and its subsequent interpretation will continue, in the coming years, to give rise to significant practical questions of application before national courts and the CJEU.

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