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The preliminary ruling of the European Court of Justice (ECJ) in Sanofi Pasteur SA confirms that there are two separate bases of liability in defective product claims and that fault-based liability claims brought under national law can co-exist with strict liability claims brought under the Product Liability Directive (85/374/EEC) (PLD).
The ECJ also clarifies whether the 10‑year long‑stop under the Product Liability Directive is compatible with the right of access to a court under Article 47 of the EU Charter of Fundamental Rights, and how limitation periods should be calculated under the Product Liability Directive in progressive illness cases.
Background
On 26 March 2026, the ECJ issued its preliminary ruling in LF v Sanofi Pasteur SA (Case C‑338/24), which was referred by the Court of Appeal, Rouen, France. The referral was made in proceedings between LF (Claimant) and Sanofi Pasteur SA (a vaccine manufacturer) concerning an application for compensation for alleged harm following a vaccination.
In 2003, the Claimant received a vaccine manufactured by the Defendant (Sanofi Pasteur) and, from 2004 onward, reported various symptoms, infections, and pain. Medical investigations in 2008 diagnosed her with a condition (macrophagic myofasciitis), which indicated the residual presence of aluminium hydroxide (a vaccine adjuvant). In 2015, she applied to the French medical accidents compensation body, which ordered an expert report. The expert concluded that her condition had stabilised in September 2016 and that a causal link between the vaccine and her illness could not be established, leading to the rejection of her claim.
The Claimant took issue with the expert report and, in June 2020, commenced proceedings against Sanofi Pasteur, claiming compensation on both a defective-product and a fault‑based liability basis. Her claims were initially dismissed as time‑barred, a decision upheld on appeal, before the Court of Cassation (the French Supreme Court) overturned the decision.
The Court of Cassation held that the limitation period could not begin to run in the case of a progressive illness without a clear stabilisation date and referred the case back to the Court of Appeal. The Court of Appeal decided to stay the proceedings and to refer questions to the ECJ for a preliminary ruling.
The ECJ’s ruling in Sanofi Pasteur and its effect on product liability law in Ireland
The questions referred by the French Court of Appeal to the ECJ concerned:
- whether fault‑based liability claims can co-exist with claims brought under the PLD;
- whether the PLD’s 10‑year long‑stop is incompatible with the right of access to a court under Article 47 of the EU Charter of Fundamental Rights; and
- when the PLD’s 3-year limitation period begins in cases of progressive injury.
On the first question, the ECJ held that the PLD creates a strict, no‑fault liability regime under which a claimant must establish damage, a defect, and a causal link between the two, but need not prove negligence. However, the Court confirmed that the PLD does not preclude a person injured by a defective product from seeking compensation for that damage from the producer under a general fault-based liability system, provided the alleged wrongdoing goes beyond the mere existence of a defect; for example, where a producer has knowingly allowed a defective product to remain on the market.
This confirms the standing position in Ireland that there are two separate bases of liability in defective product claims, and both may arise in the same legal proceedings. The first is based on common law and the principles of negligence, and the second is based on EU legislation and the strict liability rules under the PLD.
n the second question, the ECJ found no basis for concluding that the ten‑year long‑stop period under the PLD is incompatible with the right of access to a court under the EU Charter of Fundamental Rights. Under the PLD, there is a backstop date of 10 years from the date the product was placed on the market for any claims, or 25 years where a personal injury was not discoverable for a longer period. The ECJ held that the long‑stop represents a legitimate balance between consumer protection and legal certainty for producers, even in cases involving progressive injuries.
Finally, on the third question in relation to the three‑year limitation period, the ECJ rejected the argument that time only begins to run once the Claimant’s condition has fully stabilised and the full extent of the injury is known. Instead, the Court confirmed that time begins to run when the Claimant knew, or ought reasonably to have known, of the damage (once it has become apparent), the defect and the producer’s identity, regardless of any subsequent progression of the damage.
For Irish practitioners, this aligns well with domestic jurisprudence under the Statute of Limitations 1957, which already recognises the concept of “date of knowledge” in defective product and personal injury actions.
Conclusion
Overall, one of the most significant aspects of the judgment is the Court’s affirmation that the EU product liability regime does not displace national fault‑based systems, provided that the basis of liability is genuinely distinct.
Both avenues are essential; the strict liability regime under the PLD allows injured people to recover compensation without having to prove fault, which is crucial where defects are complex or technical and difficult to investigate. At the same time, the ability to also bring a negligence claim ensures accountability where harm arises from a manufacturer’s conduct, such as failures in warnings, testing or post‑market monitoring, rather than the product’s design alone.
The PLD applies until 9 December 2026, the implementation date of the Revised Product Liability Directive ((EU) 2024/2853) (Revised Directive). The Revised Directive will apply to products placed on the EU market or put into service after 9 December 2026, and manufacturers must prepare for a more stringent compliance environment. For products placed on the market before this date, the Liability for Defective Products Act 1991, which transposed the PLD into Irish law, will continue to apply. For more information on the Revised Directive, see our article here: The Future of Product Liability under Revised EU Directive.
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