Background
The proceedings arose from litigation in France. The claimant was administered a vaccine manufactured by Sanofi Pasteur in 2003. She developed a range of progressive symptoms from 2004 onwards and was diagnosed in 2008 with macrophagic myofasciitis, a rare immune‑mediated muscle disorder. The claimant attributed this diagnosis to aluminium‑based adjuvants contained in the vaccine.
The claim encountered difficulties relating to causation and, critically, limitation. In that context, the Cour d’appel de Rouen (Court of Appeal) referred a request for a preliminary ruling to the CJEU. It sought guidance on three issues under the PLD:
- The determination of the starting point of the three‑year limitation period under Article 10
- The validity of the 10‑year “long-stop” under Article 11 in light of Article 47 of the Charter of Fundamental Rights of the European Union (the Charter), and
- The extent to which claims under the Directive may coexist with national fault‑based liability regimes in accordance with Article 13.
Decision
The CJEU’s findings reinforce a strict interpretation of the Directive’s procedural timelines to ensure legal certainty for producers while maintaining high standards of consumer protection.
1. The three-year limitation period (Article 10)
Article 10 requires that proceedings are brought within three years from the date on which the injured person became aware, or should reasonably have become aware, of:
- The damage
- The defect, and
- The identity of the producer
The CJEU clarified that “awareness of damage” does not require knowledge of the full or final extent of the harm. It also does not depend on the medical stabilisation or consolidation of the injury. The limitation period begins once the damage has definitively become apparent and can be linked to the product. The Court explicitly ruled that the progressive nature of an illness does not delay this start date. It further held that national rules that postpone the limitation period until a condition stabilises are incompatible with the Directive.
2. The 10-Year long-stop (Article 11)
Article 11 of the PLD provides that the rights conferred by the Directive are extinguished 10 years after the producer puts the product into circulation. This is the case unless proceedings have been instituted within that period. The referring court questioned whether this absolute long‑stop is compatible with Article 47 of the Charter, the right to an effective remedy and to a fair trial, particularly in cases involving progressive illness.
The CJEU upheld the validity of Article 11. It reasoned that, given its interpretation of Article 10, claimants suffering from progressive illness are not, as a rule, deprived of effective access to a court. The three‑year limitation period begins when damage has definitively become apparent and can be linked to the defective product, rather than when the injury stabilises. Therefore, injured persons will ordinarily be able to bring proceedings within the 10‑year period.
The Court further distinguished progressive illnesses from cases involving latent injury, where harm may remain entirely unknowable for many years. It held that the exceptional approach adopted by the European Court of Human Rights in latent disease cases is not applicable in this context. Article 11 therefore remains a valid mechanism for balancing victim protection with producer predictability.
3. Coexistence of liability regimes (Article 13)
The Court confirmed that the PLD does not prevent an injured person from pursuing national fault‑based claims alongside, or instead of, claims under the Directive. However, the Court drew a clear and important distinction. The Directive achieves complete harmonisation regarding strict, in other words “no‑fault”, liability for defective products. Member States are therefore precluded from maintaining or applying parallel no‑fault regimes that duplicate the Directive’s liability system on the same legal basis.
By contrast, Article 13 preserves the availability of other liability routes founded on a different legal basis, in particular national fault‑based regimes. These claims are permissible where they require proof of specific wrongful conduct on the part of the producer. For instance, they include a failure to exercise appropriate vigilance, the continued marketing of a product despite known safety risks, or other breaches of a duty of care linked to product safety. Where liability rests on such fault‑based grounds, Article 13 does not prevent the claimant from relying on national law in addition to, or as an alternative to, the Directive.
Impact
For producers with products on the market in Ireland, this ruling is helpful. It clarifies important limitation issues under the PLD and the Liability for Defective Products Act 1991 (as amended), which transposes the Directive into Irish law
By its strict interpretation of these limitation periods, the CJEU has provided more certainty for businesses when managing long‑tail statutory liability exposure. Crucially, the Court reaffirmed the application of the PLD’s existing limitation periods to evolving injuries. It also rejected the expansive interpretation that time only begins to run once a claimant’s condition has fully stabilised. This should support defendants and their insurers in pursuing limitation challenges under the PLD where proceedings are not issued within three years of an injury first becoming definitively apparent, regardless of subsequent evolution. The Court’s validation of the 10‑year long‑stop further strengthens this position. By confirming that this provision is compatible with fundamental rights, the CJEU has reinforced the long‑stop as a hard deadline for statutory strict liability claims. This provides a clear and predictable cut‑off point. It also underscores the importance of maintaining accurate batch‑release and distribution records to evidence the ‘date of circulation’. However, the application of the long-stop provision will typically not provide a complete answer to product liability claims before the Irish Courts where concurrent fault‑based claims under national law are to be expected.
Looking ahead
While this ruling solidifies the "old" regime, change is imminent. The new Product Liability Directive[3], which must be transposed by December 2026, will introduce a 25-year long-stop specifically for latent personal injuries. While this reform will give enhanced protection to claimants, it risks undermining the legal certainty under the current regime. Until then, LF v Sanofi confirms that for progressive illnesses, the 10-year rule remains the standard.
For more information, contact a member of our Product Liability team.
The content of this article is provided for information purposes only and does not constitute legal or other advice.
[1] (C‑338/24)
[2] (85/374/EEC)
[3] (EU 2024/2853)