knowledge 6 May 2026 |

When does the Clock Start? Key Takeaways from the CJEU’s recent Sanofi Pasteur judgment

Introduction

Less than a year before the transposition of the revised Product Lability Directive¹, the Court of Justice of the European Union (“CJEU”) has provided some welcome clarification on the application of the limitation periods for claims made pursuant to the Product Liability Directive (PLD)². In the case of LF v Sanofi Pasteur³, the CJEU considered three important questions addressing (i) the coexistence of fault-based liability with liability under the PLD; (ii) the validity of the ten-year long-stop period and its compatibility with Article 47 of the Charter of Fundamental Rights of the EU (“the Charter”); and (iii) the date from which the time runs in the three-year limitation period for bringing such claim under Article 10 PLD.

Background

The claim arose from alleged harm suffered by LF after receiving a vaccine in 2003 which was manufactured by the Defendant.  The Plaintiff developed progressive symptoms from 2004 and in 2008, was diagnosed with macrophagic myofasciitis, which was allegedly linked to the vaccine. The Plaintiff’s case was unsuccessful at first instance on the grounds that a causal link between the vaccine and the illness could not be established. Following a number of appeals of this case, three questions of law were referred to the CJEU, on which judgment has now been delivered.

Article 13

The first question concerned Article 13 of the PLD which provides that the PLD does not deprive an injured party’s existing rights to claim compensation under national fault-based regimes or special liability regimes.  The issue before the CJEU was whether Article 13 permitted a claim under the national fault-based regime for wrongful conduct linked to product safety. On this point, it was held that an injured party was not precluded from making a fault-based claim by Article 13, provided that the basis of the claim is different from the defect claim under Article 6 PLD.

This conclusion by the CJEU while unsurprising, was a welcome clarification following the González Sánchez⁴ decision which brought some uncertainty to the issue. The practical impact of this clarification is that it is now confirmed that claimants can bring claims not only under the PLD regime, but also on the grounds of fault on the part of the manufacturer, so long as the basis of the latter claim is not mere defectiveness. The Court stated that such fault-based liability may arise for example where a producer fails to withdraw a product  despite knowledge of a lack of safety, where it breaches its duty of care regarding the risks posed by that product, or any other form of wrongful conduct linked to a lack of safety in respect of the product.

The clarification, while welcome, will likely have little impact on the conduct of product liability claims in Ireland, which are regularly pleaded under both the no fault PLD as well as negligence and breach of duty.

Article 10

The CJEU next examined the question of the starting point of the three-year limitation period prescribed by Article 10 of the PLD.  Article 10 provides that an action against the manufacturer is subject to a three-year limitation period which begins to run from the day on which the plaintiff became aware, or should reasonably have become aware of the damage, defect and identity of the producer. The CJEU considered whether it could be said that the three-year period only begins to run from the date on which the condition of the injured person stabilised or the damage ceased to evolve. In rejecting the notion of stabilisation of an injury being the trigger to start the three-year period, and departing from the opinion of the Advocate General, the CJEU stated that it would undermine the principle of legal certainty and potentially nullify the provisions under Article 11 of the PLD. It noted that the stabilisation of a progressive illness is inherently uncertain, may never occur, or could moreover be the date of death of the injured person.

On the basis of these considerations, the Court held that the starting point for the three-year period was awareness of the damage, which has definitely become apparent, linked to the defective product, irrespective of evolution rather than the date on which the damage stabilises.

Long term and evolving sequalae have been recognised in recent legislation amending the Injuries Resolution Board procedure, which can now retain, with appropriate consent, claims for a longer period of time where a long-term prognosis is awaited. Somewhat unhelpfully, the language used by the CJEU in addressing Article 10(2) of the PLD, may inadvertently create uncertainty regarding the validity of Section 50 of the Personal Injuries Assessment Board Act 2003, which provides for the suspension of any applicable limitation period before the commencement of a court proceedings pending the conclusion of the Injuries Resolution Board process.  

Article 11

The Court employed its revised interpretation of Article 10 to analyse the ten-year longstop period provided for in Article 11 of the PLD. Under Article 11, an injured person’s right to claim compensation under the PLD is valid for ten years after the product was put into circulation, after which their rights under the PLD are extinguished.  The question which was referred in relation to Article 11 was whether the ten-year period was incompatible with Article 47 of the Charter, specifically in relation to the right of access to a court for a person suffering from a progressive illness/injury caused by a defective product.

The CJEU concluded that Article 11 is valid and does not violate the right of access to a court even for victims of progressive injuries/illnesses. The Court noted that Article 47 Charter rights are not absolute, and may be limited where they (i) are provided for by law; (ii) respect the essence of the rights and freedoms at issue; and (iii) are proportionate and necessary to meet the objectives at issue.  The CJEU was satisfied that each of these criteria had been met, holding that the ten-year limitation period was explicitly provided for in the PLD, reflected EU-wide harmonisation, and served in the interests of legal certainty, insurability and technological development.

Importantly, the Court made a distinction between progressive illnesses and latent illnesses on the other hand. Noting the European Court of Human Rights decision of Howald Moor and Others v Switzerland⁵  that a latent illness should be taken into account in the calculation of the limitation period, and that such illnesses were an exception to the general application of the limitation period.

New Product Liability Directive

The revised 2024 Product Liability Directive (the New PLD), which has a transposition deadline of 9 December 2026, addresses the concern regarding the 10-year limitation period and latent injury. While it retains the three-year limitation period which is subject to a ten-year longstop period, it also provides for an extended long stop of 25 years where a claim could not be initiated within 10 years due to the latency of injury. This will provide greater protection for individuals who suffer illness that manifest long after exposure to products such as pharmaceuticals or medical implants.

Conclusion

The Sanofi Pasteur judgment provides welcome clarification on a number of important issues. The Court clarified that the PLD does not preclude national fault-based regimes for compensation. It also reaffirmed and clarified the applicability of the limitation periods provided for in the PLD in the context of evolving injuries.  In doing so, the Court did not apply a more expansive approach to the limitation periods proposed by the Advocate General. Reform of the long-stop limitation period is however on the way and the New PLD’s extended long stop period for latent injury will better protect claimants with latent injury, though this is potentially at the expense of the legal certainly provided for in the existing regime.  

 

Also contributed to by Sara Lyons