Case C‑338/24

Sanofi Pasteur SA

(Request for a preliminary ruling from the Cour d’appel de Rouen)

Judgment of the Court (Second Chamber) of 26 March 2026

(Reference for a preliminary ruling – Approximation of laws – Liability for defective products – Directive 85/374/EEC – Article 13 – Relationship with the fault-based liability system – Fault by the producer linked to the defective nature of the product – Article 10 – Starting point of the three-year limitation period in the case of damage consisting in a progressive illness – Concept of ‘becoming aware of the damage’ – Article 11 – Extinguishment of the rights of the injured person – Validity – Article 47 of the Charter of Fundamental Rights of the European Union – Right of access to a court)

Approximation of laws – Liability for defective products – Directive 85/374 – Action for compensation against the producer – Action on the basis of the general fault-based liability system – Reliance on wrongful conduct by the producer linked to a lack of safety in respect of the defective product – Whether permissible

(Council Directive 85/374, Art. 13)

(see paragraphs 31-35, operative part 1)
Approximation of laws – Liability for defective products – Directive 85/374 – Limitation period for the action for compensation – Start date – Date on which the claimant became aware of the damage, of the product defect and of the identity of the producer

(Council Directive 85/374, Art. 10(1))

(see paragraphs 38-44, 50, operative part 2)
Approximation of laws – Liability for defective products – Directive 85/374 – Limitation period in respect of the rights conferred on the injured person – Damage consisting in a progressive illness – Breach of the right of access to a court – No breach

(Charter of Fundamental Rights of the European Union, Art. 47; Council Directive 85/374, Art. 11)

(see paragraphs 61-71, 74-76, operative part 3)

Résumé

Hearing a referral for a preliminary ruling from the cour d’appel de Rouen (Court of Appeal, Rouen, France), the Court of Justice rules on whether the limitation period in respect of the rights conferred on persons who have suffered damage as a result of the defectiveness of a product within the meaning of Directive 85/374 ( 1 ) is compatible with Article 47 of the Charter of Fundamental Rights of the European Union, in the exceptional situation of injured persons suffering from progressive illnesses.

Having been vaccinated in 2003 with a vaccine manufactured by Sanofi Pasteur, LF experienced side effects and in 2008 was diagnosed as suffering from macrophagic myofasciitis. She brought legal proceedings in 2020, seeking compensation for the harm suffered, on the basis of the liability for defective products and fault-based liability of Sanofi Pasteur. That application was dismissed at first instance, and subsequently on appeal, on the ground that it was time-barred. The Cour de cassation (Court of Cassation, France) then set aside the judgment of the appeal court.

The case having been referred back to it, the referring court asks the Court of Justice whether a person injured by a defective product is entitled to seek compensation for that damage in reliance on wrongful conduct linked to a lack of safety in respect of that product, on the basis of the general fault-based liability system. It is also uncertain as regards how the starting point of the limitation period laid down in Article 10(1) of Directive 85/374 is to be determined and as to the validity of Article 11 of that directive in the light of the right of access to a court or tribunal within the meaning of Article 47 of the Charter of Fundamental Rights.

Findings of the Court

In the first place, the Court observes that the requisite wrongful conduct in the context of a national system of fault-based liability constitutes a different basis from a product defect within the meaning of Directive 85/374. It is precisely that difference which serves to determine, in accordance with Article 13 of that directive, whether a national liability system can be relied on alongside the liability system laid down by that directive. Accordingly, that provision does not preclude a person injured by a defective product from seeking compensation for that damage from the producer on the basis of the general fault-based liability system, relying on wrongful conduct linked to a lack of safety in respect of that product.

In the second place, the Court holds that the starting point of the three-year limitation period laid down in Article 10(1) of Directive 85/374 is the date on which the claimant became aware, or should reasonably have become aware: of the damage, which has definitively become apparent, linked to the defective product; of the product defect; and of the identity of the producer, rather than the date on which the damage stabilised. Indeed, even in the case of damage consisting in a progressive illness, that approach serves to ensure compliance with the principle of legal certainty in the interests of both the injured person and of the producer.

Last, the Court points out that the 10-year limitation period, on expiry of which the rights conferred on injured persons by Directive 85/374 are extinguished, is expressly referred to in Article 11 of that directive.

Next, the Court notes that the essence itself of the right of access to a court with jurisdiction is not affected by the mechanism put in place by Directive 85/374. Where the damage consists in a progressive illness, the injured person is able to have access to a court with jurisdiction in order to obtain a declaration on the basis of that directive of the damage caused to him or her, within three years from the date on which the damage definitively became apparent, meaning that he or she was aware or should reasonably have become aware of the existence of that damage, irrespective of its subsequent evolution. Furthermore, the fact that the three-year limitation period laid down in Article 10(1) of Directive 85/374 is confined within the ten-year period laid down in Article 11 of that directive does not affect the right of access to a court with jurisdiction, since that latter period is interrupted where the injured person brings proceedings against the producer. Similarly, that directive does not preclude an injured person, after being awarded initial compensation, from applying for additional compensation for the damage caused to him or her in the event that the damage has evolved, it being for the Member States to provide for that possibility.

Finally, the Court notes that the harmonisation of the rules on limitation pursued by Directive 85/374 was intended by the EU legislature in the interests both of the injured person and of the producer.

Furthermore, as regards the specific situation of an injured person suffering from a progressive illness, the Court emphasises that, although such a person may be uncertain as to the evolution of his or her condition, that person is not deprived of access to a court or tribunal, because it is likely that the damage linked to the product defect will become definitively apparent within the period of 10 years laid down in Article 11 of Directive 85/374. Consequently, the principles identified by the European Court of Human Rights in its judgment in Howald Moor and Others v. Switzerland ( 2 ) cannot be relied on in that respect.

In the light of the foregoing, the Court finds that no factor has been disclosed of such a kind as to affect the validity of Article 11 of Directive 85/374.

( 1 ) Council Directive 85/374/EEC of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (OJ 1985 L 210, p. 29).

( 2 ) ECtHR, 11 March 2014, Howald Moor and Others v. Switzerland (CE:ECHR:2014:0311JUD005206710, §§ 78 and 79).