Provisional text

delivered on 19 June 2025 (1)

Case C‑338/24 [LF] (i)

LF

Sanofi Pasteur SA

(Request for a preliminary ruling from the cour d’appel de Rouen (Court of Appeal, Rouen, France))

( Reference for a preliminary ruling – Directive 85/374/EEC – Consumer protection – Liability for defective products – Article 13 – Relationship with the general system of fault-based liability – Failure to exercise vigilance with respect to the risks associated with the product – Article 11 – 10-year limitation period – Expiry of the limitation period – Complex and progressive medical condition – Right of access to a court – Article 10 – Three-year limitation period – Point in time at which the limitation period begins – Establishment of a stabilisation date )

I.Introduction

1.Forty years have passed since Directive 85/374/EEC (2) introduced a system of liability without fault for defective products. That directive marks one of the earliest and probably most enduring (3) attempts at harmonisation in the field of European private law and of tortious liability in particular. (4) The area in which that directive intervened is at the ‘heart of the law of obligations’. (5) The sensitivity of that intervention is accentuated by the fact that Directive 85/374 seeks to achieve complete harmonisation in the matters it regulates, (6) resulting in a limitation of the margin of discretion left to Member States. It is therefore no surprise that many of the matters brought before the Court in relation to that directive explore what has been aptly described as the ‘latent defects of the European harmonisation’. (7)

2.Directive 85/374 seeks to achieve a complex balance among the various interests involved: the interests of consumers and producers, technological progress and product safety. Although its purpose is market integration, it has significant human implications when consumers have suffered bodily harm attributed to a defective product. The present case concerns, particularly, the exceptional situation of injured persons suffering from a progressive disease attributed to vaccination. The Court is invited to assess, in relation to those persons, whether the application of the 10-year time limit in which a claim for damages laid down in that directive must be brought is compatible with Article 47 of the Charter of Fundamental Rights of the European Union (‘the Charter’).

II.Legal framework

3.Article 10(1) of Directive 85/374 provides:

‘Member States shall provide in their legislation that a limitation period of three years shall apply to proceedings for the recovery of damages as provided for in this Directive. The limitation period shall begin to run from the day on which the plaintiff became aware, or should reasonably have become aware, of the damage, the defect and the identity of the producer.’

4.Article 11 of Directive 85/374 states:

‘Member States shall provide in their legislation that the rights conferred upon the injured person pursuant to this Directive shall be extinguished upon the expiry of a period of 10 years from the date on which the producer put into circulation the actual product which caused the damage, unless the injured person has in the meantime instituted proceedings against the producer.’

III.Background to the main proceedings and the questions referred

5.On 20 March 2003, LF was vaccinated against diphtheria, tetanus and poliomyelitis with the Revaxis vaccine, manufactured by the Sanofi Pasteur laboratory.

6.LF claims that, from 2004, she suffered various symptoms, infections and pain (affecting her digestive system, throat, shoulder, arm, hands and neck and causing urinary tract infections, lower back pain and hair loss) and, from December 2005, took repeated periods of sick leave from work.

7.She underwent various medical examinations, including a muscle biopsy of her left deltoid on 31 March 2008, which revealed macrophagic myofasciitis, indicating the residual presence of aluminium hydroxide, an adjuvant used in certain vaccines. That macrophagic myofasciitis caused her to be admitted to hospital from 2 to 5 April 2013.

8.On 2 June 2015, LF brought her case before the Commission de Conciliation et d’Indemnisation des Accidents Médicaux (Conciliation and Compensation Board for Medical Accidents; ‘the CCI’), which ordered that an expert report be drawn up.

9.The expert report found that LF’s condition had stabilised on 20 September 2016 and that it could not be concluded that her illness was caused by the Revaxis vaccination. The CCI dismissed her case on 11 January 2017.

10.On 17 and 23 June 2020, LF initiated proceedings against three different defendants, including Sanofi Pasteur, before the Tribunal Judiciaire d’Alençon (Court of Alençon, France), seeking compensation for the injuries she suffered as a result of her vaccination. Her claims relied on both liability for defective products and fault-based liability.

11.By order of 10 June 2021, the judge preparing the case for trial at the Tribunal Judiciaire d’Alençon (Court of Alençon) found that LF’s action against Sanofi Pasteur was time-barred and dismissed her claims.

12.On 30 June 2021, LF brought an appeal against that order. By judgment of 31 May 2022, the cour d’appel de Caen (Court of Appeal, Caen, France) largely upheld the contested order, and declared LF’s claims relying on liability for defective products and fault-based liability to be inadmissible.

13.By judgment of 5 July 2023, the Cour de cassation (Court of Cassation, France), in essence, set aside the judgment of the cour d’appel de Caen (Court of Appeal, Caen) and referred the case to the cour d’appel de Rouen (Court of Appeal, Rouen, France), which is the referring court.

14.The Cour de cassation (Court of Cassation) ruled, in essence, that Article 1245‑16 of the Code Civil (Civil Code) (which transposes Article 10 of Directive 85/374) must be interpreted as meaning that, in the case of physical injury, the date on which the claimant becomes aware of the damage is the date on which the damage becomes stabilised. It is only at the date of stabilisation of the damage that the claimant can assess the extent of his or her damage. In the case of a progressive medical condition in which it is impossible to identify a date of stabilisation, the three-year limitation period fixed by that provision does not start to run.

15.On 18 September 2023, LF brought proceedings before the referring court.

16.The referring court notes that the present case raises several questions of interpretation in relation to Directive 85/374. First, there is a question concerning the relationship between the system of rules governing liability for defective products and the system of rules governing fault-based liability. In particular, it concerns whether the applicant is entitled to bring an action relying on fault-based liability on one of the following grounds: the producer allowed the defective product to remain in circulation, or the producer failed to exercise vigilance with respect to the risks associated with the product or, more generally, a safety defect in the product.

17.Second, as regards the rules governing liability for defective products, the referring court raises the question of whether the 10-year limitation period for bringing an action, laid down in Article 11 of Directive 85/374, infringes the right of access to a court, in a situation in which the injured person suffers from a progressive medical condition.

18.Third, the referring court raises an issue of interpretation in relation to the three-year limitation period for bringing an action, laid down by Article 10 of Directive 85/374. In particular, it asks whether the date on which that period starts to run in the case of a complex progressive medical condition, such as that of LF, can be the date of stabilisation of the relevant medical condition.

19.In those circumstances, the cour d’appel de Rouen (Court of Appeal, Rouen, France) decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:

(1)‘(1) Must Article 13 of Directive [85/374], as interpreted by the judgment of 25 April 2002, González Sánchez, C‑183/00, EU:C:2002:255 (‘the judgment in González Sánchez’), according to which an injured person may rely on systems of contractual or non-contractual liability having a different basis from that put in place by the directive, be interpreted to mean that the victim of a defective product may seek compensation for his or her injury from the producer under a general system of fault-based liability, relying in particular on the fact that the product has been allowed to remain in circulation, a failure to exercise vigilance with respect to the risks associated with the product or, more generally, a safety defect in that product?

(2)Is Article 11 of Directive [85/374], under which the rights conferred on the victim by that directive are extinguished upon the expiry of a period of 10 years from the date on which the harmful product was put into circulation, incompatible with the provisions of Article 47 of the [Charter] in that it deprives a victim suffering from a progressive injury caused by a defective product [of] the right of access to a court?

(3)Can Article 10 of [Directive 85/374], which determines the date on which the three-year limitation period begins to run as “the day on which the plaintiff became aware, or should reasonably have become aware, of the damage”, be interpreted as meaning that the period starts to run only on the day on which the whole of the damage is known, in particular by the establishment of a stabilisation date, defined as the moment from which the condition of the victim of physical injury is no longer evolving – meaning that, where a medical condition is progressive, the limitation period does not start to run – rather than as the day when the damage has clearly appeared and can be linked to the defective product, regardless of its subsequent development?’

20.Written observations were submitted by LF, Sanofi Pasteur, the French, German and Netherlands Governments, the European Commission and the Council of the European Union. Those parties and interested parties participated in the hearing which took place on 27 March 2025 and answered the questions for oral response that were put by the Court.

IV.Assessment

A.The first question

21.By its first question, the referring court asks, in essence, whether Article 13 of Directive 85/374, read in the light of the judgment in González Sánchez, must be interpreted as meaning that a person injured by a defective product may seek compensation for his or her injury from the producer under a general system of fault-based liability, relying in particular on the fact that the product remained in circulation, a failure to exercise vigilance with respect to the risks associated with the product or, more generally, a safety defect in that product.

22.It is apparent from the order for reference that the referring court is asking this question in order to determine whether LF, the applicant in the main proceedings, who claims to have suffered damage caused by a vaccine marketed by Sanofi Pasteur, is entitled to bring proceedings against Sanofi Pasteur on the basis of fault-based liability. Specifically, LF maintained before the referring court that the fault consists in the absence of any reaction on the part of Sanofi Pasteur, despite the latter being notified of the effects of its aluminium-containing vaccine. Sanofi Pasteur argued that the fault attributed to it by LF is not distinct from the alleged safety defect.

23.The referring court points out that in a number of judgments, (8) the Cour de cassation (Court of Cassation), ruled that the victim of damage resulting from a defective product is entitled to bring an action based on fault on the part of the producer. That fault may consist in maintaining in circulation a product which has a defect of which the producer is aware, or in a failure to fulfil its duty of vigilance with respect to the risks associated with the product.

24.In the light of that case-law, the referring court’s question is to be understood as seeking, in essence, to determine whether Directive 85/374 precludes the injured person from seeking to hold the producer liable where the alleged fault is one of those described by that case-law. (9)

25.In order to address that issue, it is important, as a preliminary point, to recall the nature and essential features of the system of liability established by Directive 85/374 and the relationship between that system and the national systems of contractual and non-contractual liability.

1.Strict liability based on the defectiveness of the product

26.Article 1 of Directive 85/374, according to which ‘the producer shall be liable for damage caused by a defect in [its] product’, read in the light of the first and second recitals thereof, lays down the principle of the objective liability without fault, or strict liability, of the producer for damage caused by the defectiveness of its products. (10)

27.It is apparent from Article 4 of Directive 85/374 that, in order to seek compensation, the injured person is required to prove the damage, the defect and the causal relationship between the defect and the damage. Those three conditions are sufficient to establish liability.

28.By contrast, the producer’s fault is not relevant. The system of product liability is objective, based on the defectiveness of the product. In other words, as put in the academic literature, liability is ‘“defect based”, not “fault-based”’. (11)

29.The defect is established by objective considerations. According to Article 6 of Directive 85/374, a product is defective when it does not provide the safety which a person is entitled to expect, taking all the circumstances into account, including the presentation of the product, the use to which it could reasonably be expected that it would be put and the time when the product was put into circulation. Moreover, according to the sixth recital of that directive, that assessment must be carried out having regard to the reasonable expectations of the public at large. (12)

30.With regard to pharmaceutical products including vaccines, in the light of their functions and the intended purpose related to human health and to the specific requirements of the group of users for whom the product is intended, namely patients, the safety requirements for those products, which such patients are entitled to expect, are particularly high. (13)

31.The exclusion of subjective considerations with regard to the defectiveness of the product is also apparent from the defences on the basis of which the producer may be exonerated from liability, laid down in Article 7 of Directive 85/374. Specifically, none of those defences allows for a ‘subjective’ test to be applied, based on what the producer knew or ought to have known in relation to the product. The Court confirmed this in relation to what is commonly known as the ‘development risk defence’ laid down in Article 7(e) of that directive. That defence allows the producer to be exempted from strict liability if it establishes that ‘the state of scientific and technical knowledge at the time when [it] put the product into circulation was not such as to enable the existence of the defect to be discovered’. The Court found that the defence in question does not contemplate ‘the state of knowledge of which the producer in question actually or subjectively was or could have been apprised’. (14)

32.Thus, the considerations related to what the producer actually knew or ought to have known, and whether it had been able or ought to have been able to prevent the defect, do not fall within the sphere of product liability based on Directive 85/374. (15) Those considerations can therefore form the basis of national fault-based liability. This brings me to the relationship between the product liability system established by Directive 85/374 and the general national systems of liability.

2.Relationship between the system of strict liability laid down by Directive 85/374 and the national systems of liability

33.According to settled case-law, Directive 85/374 seeks to achieve, in the matters regulated by it, complete harmonisation of the laws, regulations and administrative provisions of the Member States. (16)

However, as follows from the eighteenth recital of Directive 85/374, that directive does not seek exhaustively to harmonise the sphere of liability for defective products beyond the matters regulated by it. (17)

35.Article 13 of Directive 85/374 sets out the basic rule governing the relationship between the system of liability without fault established by the directive and the national systems of liability: that directive ‘[does] not affect any rights which an injured person may have according to the rules of the law of contractual or non-contractual liability or a special liability system existing at the moment when [that] Directive is notified’.

36.In the judgment in González Sánchez the Court ruled that Article 13 of Directive 85/374 cannot be interpreted as giving the Member States the possibility of maintaining a general system of product liability which is different from that provided for in that directive. (18)

37.Thus, the reference in Article 13 of Directive 85/374 to the rights on which an injured person may rely under the rules of the law of contractual or non-contractual liability must be interpreted as meaning that the system of rules put in place by that directive ‘does not preclude the application of other systems of contractual or non-contractual liability based on other grounds, such as fault or a warranty in respect of latent defects’. (19)

38.While it is clear that the system of liability without fault established by Directive 85/374 coexists with national systems of fault-based liability, the question that needs to be examined is whether fault can refer to the defectiveness of a product.

3.Can fault refer to the defectiveness of a product?

39.As already pointed out above, the system of liability laid down in Directive 85/374 is decoupled from any requirement of fault on the part of the producer in relation to a defective product. (20) Where fault is involved in relation to a defective product, the liability is different in nature from that established by the directive. That directive does not, therefore, prevent a Member State from providing that the producer could be held liable for fault-based conduct in relation to a defective product. Such conduct can be the maintaining in circulation of a product which has a defect of which the producer is aware or a failure to exercise vigilance and take preventive measures by stepping up experimentation and research investment with respect to the risks associated with the product, of which the producer has been notified.

40.The recognition of fault-based liability in such situations does not conflict with the system of liability laid down by Directive 85/374. That is so because the conduct giving rise to the fault-based liability in the relevant situations, although it necessarily relates to the defect and the safety of the product, does not depend exclusively on the defect. It is the proof of specific wrongful behaviour on the part of the producer which differentiates the nature of the general liability from that of the strict liability established by Directive 85/374.

41.It must be noted that a producer’s failure to exercise vigilance despite being notified of possible risks of harm associated with a product is also different from the situation on which the Court ruled in the judgment in Commission v France. (21) According to that judgment, the French Republic failed to fulfil its obligations under Directive 85/374 due, among other grounds, to the incorrect transposition of Article 7 of Directive 85/374. Specifically, French law provided that the producer could not rely inter alia on the development risk defence, unless it was able to prove that it had taken appropriate steps to avert the consequences of a defective product (the so-called obligation to ‘monitor’ the product (22)). The Court found that while Member States are allowed to remove entirely the ground of exemption from liability provided for in Article 7(e) of Directive 85/374, pursuant to Article 15 of that directive, they are not authorised to alter the conditions under which the exemption is applied. (23)

42.The establishment of a general requirement to monitor the product as a condition for a producer to plead the development risk defence, which was the subject of the judgment in Commission v France, (24) is a different issue from that raised in the present case. The referring court describes a situation in which the producer, although warned of the possible risks arising from the defectiveness of the product, fails to exercise due care and to take appropriate measures to avert the harmful consequences of the defective product. The liability incurred therefore does not relate exclusively to the defectiveness of the product but relates also to the fault attributed to the producer.

43.In view of the above, I consider that Article 13 of Directive 85/374, read in the light of the judgment of the Court in González Sánchez, must be interpreted as meaning that the person injured by a defective product may seek compensation for his or her injury from the producer under a national general system of fault-based liability, to the extent that such a system is not based exclusively on the defectiveness of the product. The fault may consist, in particular, in maintaining a product in circulation despite the producer being aware of its defectiveness or in a failure to exercise vigilance with respect to the risks associated with the product, despite the producer having been notified of those risks.

B.The second question

44.By its second question, the referring court asks, in essence, whether Article 11 of Directive 85/374, according to which the rights conferred on an injured person by that directive are extinguished upon the expiry of a period of 10 years from the date on which the harmful product was put into circulation, is contrary to the right of access to a court guaranteed in Article 47 of the Charter, to the extent that it deprives an injured person suffering from a progressive disease caused by a defective product of the right of access to a court.

45.Article 11 of Directive 85/374 provides for a complete harmonisation of the rules on the limitation of rights conferred on an injured person pursuant to that directive. (25) It sets out a uniform 10 –year period after which those rights are extinguished (‘the expiry period’) and the producer is relieved of liability under the system established by that directive. It fixes, in a binding manner, the starting point of that period as the date on which the producer put into circulation the product which caused the damage. It specifies the institution of proceedings against that producer as the only reason for that period to be interrupted. (26)

46.In the judgment in Aventis Pasteur, the Court stressed that, as is apparent from the tenth recital of Directive 85/374, the EU legislature intended the harmonisation of the rules on limitation pursued by that directive to be in the interests both of the injured person and of the producer. (27)

47.The harmonisation of the rules on limitation contributes, first, to the general aim expressed in the first recital of Directive 85/374, which consists in putting an end to the divergences between national rights liable to entail differences in the degree of protection of consumers within the European Union. (28)

48.Second, according to the eleventh recital of Directive 85/374, the harmonisation seeks, at EU level, to limit the liability of the producer to a reasonable length of time, having regard to the fact that products age, and to increasingly strict safety standards and the constant progress in the state of science and technology. (29)

49.The Court has further noted that the EU legislature’s intention to limit in time the liability without fault established by Directive 85/374 is also intended to take account of the fact that that liability represents a greater burden for the producer than liability under a traditional system, so as not to restrict technical progress and in order to maintain the possibility of insuring against risks connected with that specific liability. (30)

50.Article 11 of Directive 85/374 therefore seeks to grant the producer legal certainty as to the exact date on which the latter is to be relieved of its liability under that directive. (31)

51.In the context of the present case, the doubts of the referring court concern whether Article 11 of Directive 85/374 is compatible with Article 47 of the Charter in so far as the expiry period it lays down applies to injured persons suffering from a progressive disease.

52.Directive 85/374 contains no definition of what constitutes a ‘progressive disease’. Article 9(a) thereof defines ‘damage’ as damage resulting from death or personal injuries. It follows from the judgment in Veedfald that it is left to the national legislatures to determine the precise content of those heads of damage, provided that full and proper compensation is available for persons to whom damage is caused by a defective product. (32)

53.Given the broad definition of ‘damage’, that concept may cover a progressive disease understood as a medical condition that evolves over a long period.

54.In order to address the issue of the compatibility of Article 11 of Directive 85/374 with Article 47 of the Charter, it is necessary to determine, at the outset, whether the time limit for bringing proceedings interferes with a right guaranteed by EU law.

55.The Netherlands Government, the Commission and the Council assert in their written observations that the setting of the expiry period does not constitute a limitation of a right guaranteed by EU law. That is so, they submit, because when the relevant period has elapsed the injured person’s right to claim damages is extinguished. Since there is no right, the victim can no longer rely on rights and freedoms guaranteed by EU law and there can therefore be no infringement of Article 47 of the Charter. The expiry period is to be understood, according to that view, simply as a temporal limitation of the rights that the injured persons have under Directive 85/374, and once it has elapsed the Charter does not apply.

56.I cannot subscribe to that approach in the interpretation of Article 47 of the Charter.

57.Article 51(1) of the Charter confirms the Court’s settled case-law, which states that the fundamental rights guaranteed in the legal order of the European Union are applicable in all situations governed by EU law. (33)

58.The first paragraph of Article 47 of the Charter provides that everyone whose rights and freedoms guaranteed by the law of the European Union are violated has the right to an effective remedy before a tribunal in compliance with the conditions laid down in that article.

59.It is also clear from the settled case-law of the Court that the right to an effective remedy may be invoked solely on the basis of Article 47 of the Charter, without there being a need for the content thereof to be made more specific by other provisions of EU law or by provisions of the domestic law of the Member States. The recognition of that right, in a given case, presupposes, as is apparent from the first paragraph of Article 47 of the Charter, that the person invoking that right is relying on rights or freedoms guaranteed by EU law. (34)

60.The situation of a person injured by a defective product, claiming compensation from the producer under the liability without fault established by Directive 85/374, clearly falls under EU law. By relying on the right to compensation under that directive, the injured person relies on the right to an effective remedy under Article 47 of the Charter.

61.The fact that Article 11 of Directive 85/374 provides for an expiry period after which the right to compensation is extinguished does not mean that the latter provision can escape any review of its compatibility with Article 47 of the Charter. Indeed, the extinguishment of the substantive right is merely the effect of application of the expiry period laid down by that directive. A review of the validity of Article 11 of Directive 85/374 in the light of Article 47 of the Charter should concentrate on the very fact that an expiry period is laid down and on its characteristics, including its length, the moment in time at which it begins and the events that can suspend or interrupt it.

62.Were that not so, any temporal limitation on the bringing of proceedings to claim EU rights laid down by secondary EU law (or by Member States when acting within the field of EU law), in the form of a period on the expiry of which the rights are extinguished, could escape the review of validity in the light of primary law depending on whether the relevant expiry period has elapsed.(35)

63.Such an approach would conflict with the principle of the rule of law, according to which neither the Member States nor the institutions of the European Union can avoid a review of whether their acts are in conformity with the Treaties. (36)

64.Thus, the setting of an expiry period for bringing proceedings, in Article 11 of Directive 85/374, must be regarded as giving rise to a limitation of the right of an injured person to an effective remedy. It is necessary to examine, next, whether such a limitation can be justified.

65.The Court has already held that the principle of effective judicial protection laid down in that Article 47 of the Charter, consists of various elements, including the right of access to the courts. (37)

66.Article 47 of the Charter secures in EU law the protection afforded by Article 6(1) of the European Convention on Human Rights (‘ECHR’). (38)

67.In accordance with Article 52(3) of the Charter, in so far as the Charter contains rights which correspond to rights guaranteed by the ECHR, the meaning and scope of those rights are to be the same as those laid down by that convention, although the foregoing does not preclude EU law from affording more extensive protection. Therefore, when interpreting Article 47 of the Charter, the Court must take account of the corresponding rights guaranteed by Article 6(1) ECHR, as interpreted by the European Court of Human Rights, as the minimum threshold of protection. (39)

68.It is clear from the case-law of the Court that the right of access to a court is not an absolute right and that, consequently, it may involve proportionate restrictions that pursue a legitimate aim and do not adversely affect the very essence of that right. (40) As can be seen from Article 52(1) of the Charter, that provision allows limitations to be placed on the exercise of those rights, provided that those limitations are provided for by law, that they respect the essence of those rights and that, in compliance with the principle of proportionality, they are necessary and genuinely meet objectives of general interest recognised by the European Union or the need to protect the rights and freedoms of others. (41)

69.In the first place, as regards the requirement that any limitation on the exercise of fundamental rights must be provided for by law, Article 11 of Directive 85/374 expressly lays down the rule on the expiry period. The principle of legality is therefore complied with.

70.In the second place, as regards respect for the essence of the right of access to a court, the Court has ruled that the essence of the right to an effective remedy enshrined in Article 47 of the Charter includes, among other aspects, the possibility, for the person who holds that right, of accessing a court or tribunal with the power to ensure respect for the rights guaranteed to that person by EU law and, to that end, to consider all the issues of fact and of law that are relevant for resolving the case before it. (42)

71.In that regard, it must be noted that it follows from Article 11 of Directive 85/374 that the rights extinguished after the expiry period are only those that are conferred by Directive 85/374. Article 11 of that directive, read in the light of Article 13 thereof, (43) does not preclude the injured person from bringing proceedings on the basis of the rules of the national law of contractual or non-contractual liability to the extent that the relevant national liability system on which that person relies is different from that established by that directive. (44)

72.The Netherlands Government, the Commission and the Council maintain that, in view of the complementarity of the rights and remedies available to an injured person to claim compensation under EU law and national law, Article 11 of Directive 85/374 respects the essence of the right of access to a court. The Commission submitted, more specifically, at the hearing that there are many ‘layers of liability’ that can be activated, in view of which there can be no infringement of the right of access to a court.

73.The difficulty I see with that position is that it renders the examination of a provision of EU law conditional on rights and remedies which may be available under national law. As pointed out above, the essence of the right to an effective remedy enshrined in Article 47 of the Charter includes, among other aspects, the possibility, for the person who holds that right, of accessing a court or tribunal with the power to ensure respect for the rights guaranteed to that person

by EU law. In that regard, as the German Government put it at the hearing, that possibility is independent of the rights guaranteed to the person by the national law on tortious liability. Moreover, in view of the complete harmonisation brought about by Directive 85/374, the right to claim damages under the product liability system put in place by that directive is extinguished after the expiry period in respect of any injured person. If Member States provide for the right to claim damages after that period, that right cannot have the same foundation as that established by that directive. The persons concerned may no longer benefit from the system of strict liability in relation to a defective product, and particularly from the rules on the burden of proof.

Accordingly, the question of whether the expiry period laid down under Article 11 of Directive 85/374 respects the essence of the right of access to a court in order to uphold the right to claim damages guaranteed by that directive cannot depend on the possible existence under national law of other rights and remedies which have different foundation as the one established by that directive.

In any event, there is no obligation on Member States to provide for a longer limitation period under their general liability system that would allow injured persons to bring their claim on a different basis from that provided for under Directive 85/374.

Therefore, the coexistence of rights and remedies with a different legal foundation does not appear to be capable of establishing that the essence of the right of access to a court is not undermined.

The nature of the expiry period under Article 11 of Directive 85/374 is that of ‘an absolute deadline’. (45) The only circumstance capable of preventing the extinguishment of the rights is that the injured person has in the meantime instituted proceedings against the producer. The application of the expiry period is unconditional, (46) in that it applies systematically to every injured person, with no exceptions or any individual assessment of the nature of the harm suffered and the ability of the victims to assess the damage suffered.

The European Court of Human Rights examined the compatibility of unconditional expiry periods with the right of access to a court in the judgment in Howald Moor and Others v. Switzerland. (47) The victims in that case suffered from a latent disease linked to exposure to asbestos, which had manifested itself after expiry of the 10-year limitation period established in national law. In view of the latency periods for asbestos-related diseases lasting several decades, the European Court of Human Rights found that a fixed limitation period of 10 years which began to run on the date when the person concerned had been exposed to asbestos dust, would invariably have expired. (48) When it is scientifically proven that it is impossible for a person to know that he or she suffers from a certain illness, such a circumstance should be taken into account in the calculation of the limitation period. (49) In the light of the exceptional circumstances of that case, the European Court of Human Rights ruled that the application of the relevant limitation period had restricted access to a court to such an extent that the very substance of the applicants’ right had been infringed. (50)

The issue of the compatibility of unconditional expiry periods with the right of access to a court was raised with regard to persons suffering from a progressive disease attributed to the administration of a vaccine in the judgment of the European Court of Human Rights in Sanofi Pasteur v. France. (51) The national (French) courts had found, in essence, that the starting date of the limitation period of the victim’s action was the date of stabilisation of the damage. The pharmaceutical company claimed that the method of establishing the starting point of the limitation period was in breach of the principle of legal certainty as recognised in Article 6(1) ECHR and its right to the peaceful enjoyment of its possessions as guaranteed by Article 1 of Protocol No 1 thereto.

The European Court of Human Rights acknowledges that there is a difference between the victims of a latent disease in Howald Moor and Others v. Switzerland and the victims of a progressive disease in Sanofi Pasteur v. France. While the former did not know about their illness until the time limits for their action had expired, the action for damages of the latter injured persons had not been time-barred at the time of diagnosis of the disease. (52) However, that difference was not decisive for the European Court of Human Rights to make a different assessment of the right of access to a tribunal of the victims of a progressive disease.

The European Court of Human Rights held, indeed, that the right to a tribunal is in issue where an action for damages lodged by a person whose physical integrity has been infringed becomes statute-barred before the person has actually been in a position to assess his or her injury. (53) It found that in view of the evolving nature of the victim’s illness and in the absence of its stabilisation, the victim was unable to ‘fully evaluate her injury’ and was therefore unable to bring proceedings against the company that had manufactured the vaccine on a date prior to such stabilisation, in order to obtain full compensation. (54)

It follows from that case-law of the European Court of Human Rights that the unconditional application of an expiry period to victims of a progressive disease is liable to interfere with the right of access to a court if the victim is precluded from bringing an action for damages before he or she is in a position to assess the full extent of his or her injury.

Following that line of reasoning, the unconditional application of the expiry period provided in Article 11 of Directive 85/374 to all injured persons, and in particular those suffering from a progressive disease who, according to medical evidence, could not know the full extent of their injury, appears liable to impair the very essence of their right of access to a court guaranteed by Article 47 of the Charter.

The Netherlands Government argued, however, that the essence of the right of access to a court for injured persons suffering from a progressive disease is not impaired by Article 11 of Directive 85/374. That is so because it is clear that there is damage, even though the extent of the damage may increase. The victim of a progressive disease, as opposed to the victim of a latent disease, can thus bring an action for damages before the expiry period has elapsed.

The German Government also supports that position and takes the view that it falls on the Member States to allow the injured persons to take an action before it is time-barred. It explained in its written submissions and at length at the hearing that, under German legislation, the victim can bring a declaratory action (Festellungsklagge). (55) That declaratory action is intended to establish the liability of the producer to pay damages, even though the damage is evolving and the amount is not yet quantifiable. Moreover, it interrupts the expiry period set out under Article 11 of Directive 85/374.

It could therefore be argued that it is for national procedural law to address the situation of injured persons suffering from a progressive disease and to provide for the appropriate mechanisms in order to prevent the action of those persons from being time-barred. Following that approach, it would not be Article 11 of Directive 85/374 that would infringe the right of access to a court, but national procedural law, if the situation of those persons is not taken into consideration.

That approach, nevertheless, does not withstand scrutiny. First, it sits uneasily with the complete harmonisation of the limitation period brought about by that provision and may lead to fragmentation of the protection of the right of access to a court for victims of a progressive disease. In that regard, it must be recalled that unlike the limitation period under Article 10(2) of Directive 85/374, which leaves the laws of the Member States regulating suspension or interruption unaffected, the expiry period under Article 11 of that directive makes no reference to such laws. Following a question put by the Court to the Commission at the hearing as to the characteristics of that latter period, the Commission maintained that any national procedural mechanisms that may apply to address the situation of a progressive disease should not undermine the complete harmonisation brought about by the expiry period.

Second, the approach consisting in leaving the matter to national procedural autonomy does not appear to be capable of addressing the risk that the establishment by EU law of an unconditional expiry period will create unsuccessful claims. If injured persons are obliged to bring their action premature, before they are able to evaluate their illness, they run the risk of not having access to all the information. (56) LF’s counsel submitted at the hearing that, without all the information available, the injured person will obtain an unfavourable expert report. The injured person’s action is then destined to result in incomplete compensation or, worse, to fail. Such an outcome would be contrary to Article 47 of the Charter, which guarantees the possibility for the person who holds the right to prepare and bring an effective action. In the words of European Court of Human Rights case-law, the right of access to a court must be ‘practical and effective’, not ‘theoretical or illusory’. (57)

For those reasons, I consider that the unconditional application of the expiry period established in Article 11 of Directive 85/374 to all injured persons, without consideration of the particular circumstances of those persons suffering from a progressive disease whose illness has not stabilised before expiry of that period, does not respect the essence of the right of access to a court guaranteed by Article 47 of the Charter.

In the third place, in the event that the Court does not agree with my analysis in relation to the essence of the right of access to a court, it will be necessary to verify whether the expiry period laid down in Article 11 of Directive 85/374 observes the principle of proportionality, in so far as it applies to injured persons suffering from a progressive disease.

The principle of proportionality requires that the limitations which may, in particular, be imposed by acts of EU law on rights and freedoms enshrined in the Charter do not exceed the limits of what is appropriate and necessary in order to meet the legitimate objectives pursued or the need to protect the rights and freedoms of others. Where there is a choice between several appropriate measures, recourse must be had to the least onerous. In addition, an objective of general interest may not be pursued without having regard to the fact that it must be reconciled with the fundamental rights affected by the measure, by properly balancing the objective of general interest against the rights at issue, in order to ensure that the disadvantages caused by that measure are not disproportionate to the aims pursued. (58)

With regard to whether the expiry period meets an objective of general interest, it must be recalled that according to the Court’s settled case-law the setting of reasonable time limits for bringing actions on pain of foreclosure, in the interests of legal certainty, is compatible with EU law. (59) Article 11 seeks specifically to grant the producer legal certainty in the context of the system of liability without fault established by that directive. (60)

The European Court of Human Rights has also consistently acknowledged that the legal time limits for statutory limitation, which constitute one of the legitimate restrictions on the right to a tribunal, serve important purposes, namely to ensure legal certainty and finality, protect potential defendants from stale claims which might be difficult to counter and prevent any injustice which might arise if courts were required to decide upon events which took place in the distant past on the basis of evidence which might have become unreliable and incomplete because of the passage of time. (61)

Furthermore, the European Court of Human Rights has emphasised that the principle of legal certainty constitutes one of the fundamental aspects of the rule of law. (62)

Legal certainty and the sound administration of justice constitute, therefore, objectives of general interest recognised by the European Union for the purposes of Article 52(1) of the Charter, which justify a limitation on the exercise of the rights guaranteed by Article 47 of the Charter.

As regards the question of whether the expiry period at issue exceeds the limits of what is appropriate and necessary for the attainment of those objectives, it must be noted that the rules on liability without fault set out in Directive 85/374 are the result of a complex balancing of different interests. (63) It follows from the case-law referred to above (64) that the rules on limitation ensure legal certainty and take account of the fact that no-fault liability represents a greater burden for producers than liability under a national general system, a burden which is also reflected in the need to take out insurance against risks connected with that specific liability. (65)

Taking into account the wide margin of discretion available to the EU legislature to balance the various interests involved, an expiry period of 10 years starting from the placing of the defective product on the market appears ‘in general’ and ‘in the vast majority of cases’, as the Commission stated in its written observations, sufficiently long to allow victims to bring an action against the producer.

However, as eloquently put in the legal literature, no ‘one-size-fit[s]-all’ expiry period can properly balance the interests of victims of bodily harm and producers. (66) While in abstract the expiry period appears sufficiently long for the injured persons, it does not appear to be tailored to certain exceptional instances of bodily harm where the harm does not occur immediately or shortly after the harmful event but is progressive. A failure to give any consideration to that specific situation would disregard the fact that the extinguishment of the rights of those injured persons is not the result of their inaction but of their misfortune to suffer from a progressive disease.

The Commission submitted, in essence, in its written observations and at the hearing, that the injured persons suffering from progressive disease can bring an action within the expiry period when they are aware of some symptoms and obtain some compensation (‘un certain dédommagement’). That compensation will necessarily be partial if the effects of the defective product are not fully detectable when the action is brought. Moreover, the Commission stated that if the rules of national law so provide, the injured person could ask for a stay of the proceedings until the damage is known in its entirety, in order to allow that person to supplement his or her initial application and obtain full reparation of the damage.

For the reasons I have set out above, (67) the option of obtaining partial damages does not appear satisfactory from the perspective of the right of an injured person to bring an effective action. Moreover, the fact that national procedural law may afford a possibility of seeking a stay of the proceedings until the full extent of the harm is known, apart from being hypothetical, might, depending on the exact provisions of national law, be inconsistent with the complete harmonisation brought about by Directive 85/374 of the expiry period.

The need to address the disproportionate results of applying an absolute expiry period for certain categories of harm is borne out by the amendments brought about under Directive (EU) 2024/2853. (68) Article 17(2) of that directive introduces a derogatory provision with regard to injured persons who have not been able to initiate proceedings within the expiry period due to the latency of a personal injury. For those injured persons, the expiry period is extended to 25 years. It follows from recital 57 of that directive that the EU legislature extended the expiry period ‘in order to avoid unreasonably restricting the possibility of compensation for damage caused by a defective product …in cases where the symptoms of a personal injury are, according to medical evidence, slow to emerge’.

Although Directive 2024/2853 is not applicable to the case in the main proceedings, (69) the reasons underlying the modification of the expiry period demonstrate that a failure to give any consideration to the particularities of specific categories of harm is liable to affect the right of access to a court for the injured persons concerned.

For those reasons, I consider that the application of the expiry period laid down in Article 11 of Directive 85/374 disproportionately affects the right of access to a court of injured persons suffering from a progressive disease who, due to the evolving nature of their disease, cannot fully evaluate their condition and have therefore been unable to initiate proceedings against the producer within that period.

The detailed rules for tailoring the expiry period to the exceptional instances of injured persons suffering from a progressive disease and the balancing of all the interests involved are matters to be decided by the EU legislature.

In the light of the foregoing, I take the view that Article 11 of Directive 85/374, under which the rights conferred on an injured person by that directive are extinguished on expiry of a period of 10 years from the date on which the harmful product was put into circulation, is invalid in the light of Article 47 of the Charter, in so far as its application has the effect of extinguishing the right to claim compensation of injured persons suffering from a progressive disease who, according to medical evidence, due to the progressive nature of their medical condition, cannot fully evaluate the damage caused to them and have therefore been unable to initiate proceedings against the producer within that period, thereby depriving those persons of their right of access to a court.

C.The third question

By its third question, the referring court asks, in essence, whether Article 10 of Directive 85/374 must be interpreted as meaning that, in the case of a progressive disease, the three-year limitation period for the recovery of damages starts to run on the day when the full extent of the damage is known, in particular by the establishment of a stabilisation date, defined as the moment from which the condition of the victim is no longer evolving. The referring court also asks whether, alternatively, that limitation period must be understood as running from the date when the damage clearly appeared and can be linked to the defective product, regardless of its subsequent development.

107.It is apparent from the order for reference that the case in the main proceedings was referred by the Cour de cassation (Court of Cassation) to the referring court, on the ground that the Cour d’appel de Caen (Court of Appeal, Caen) had ruled that the action of LF was inadmissible without considering whether her medical condition had stabilised. (70)

108.It must be recalled that Article 10(1) of Directive 85/374 establishes as the starting date of the three-year limitation period the date on which the plaintiff ‘became aware, or should reasonably have become aware, of the damage, the defect and the identity of the producer’. The referring court’s question concentrates on determining the date on which the injured person (who is the plaintiff) suffering from a progressive disease became aware of the damage.

109.According to settled case-law, it follows from the need for a uniform application of EU law and the principle of equality that the terms of a provision of EU law which makes no express reference to the law of the Member States for the purpose of determining its meaning and scope must normally be given an independent and uniform interpretation throughout the European Union, having regard not only to the wording of that provision but also to the context in which it occurs and the objectives pursued by the rules of which it is part. (71)

110.Article 10(1) of Directive 85/374 makes no express reference to the laws of Member States in order to establish the starting date for the limitation period. Article 10(2) refers to national laws only with regard to regulating the suspension or interruption of the limitation period, not in relation to the dies a quo. Moreover, giving an independent and uniform interpretation of the starting date for the limitation period is, as is apparent from the tenth recital, consistent with the objective of that directive of establishing a uniform period of limitation for the bringing of an action for compensation.

111.With regard to the wording of Article 10(1) of Directive 85/374, that provision links the starting date of the limitation period to the awareness (or deemed awareness) of the damage. It does not appear possible to deduce from that wording alone whether the awareness must be understood as being acquired only on the stabilisation date of the medical condition of the injured person, or on the date when the damage clearly appeared, irrespective of its future deterioration.

112.With regard to the context of Article 10(1) of Directive 85/374, it must be recalled that, according to Article 4 thereof, the injured person is required to prove the damage, the defect and the causal relationship between the defect and the damage. It is clear from Article 9(a) of Directive 85/374 that ‘damage’ covers damage resulting from death or from personal injuries.

113.It is apparent from the Court’s case-law that full and proper compensation for persons injured by a defective product must be made available for the kind of damage referred to in the preceding point. (72)

114.The date on which the limitation period starts to run under Article 10(1) of Directive 85/374 must be set in such a manner as to enable the injured person to prove that all the conditions are met in order for the producer to incur liability. Accordingly, as the Commission essentially submitted, the injured person must have sufficiently complete knowledge of the circumstances relating to all those conditions, including a sufficiently complete knowledge of the damage. The sufficiently complete knowledge of the damage allows the injured person to obtain full and proper compensation.

115.In general, knowledge of the date when the damage clearly appeared can be considered to be an appropriate requirement in order for injured persons to bring an action. As the Commission essentially pointed out at the hearing, there are cases of bodily harm where there is no need to wait for the consolidation of the damage because there is sufficient knowledge of that damage and, depending on the circumstances, of how it will evolve in the future. However, in case of a progressive disease, in the absence of stabilisation, the injured person is unable to assess the nature of the damage suffered. The stabilisation date is to be determined on the basis of medical evidence; it does not depend on the personal assessment of the injured person. (73) Thus, for those injured persons the limitation period should not begin to run before the date of stabilisation, which is understood as the date when their medical condition ceases to evolve.

116.The alternative date proposed by the referring court, namely the date when the damage clearly appeared, if it is understood, in the case of a progressive disease, as the date on which the first symptoms manifest themselves, would be liable to seriously undermine the injured person’s ability to bring an effective action for damages. As the Commission noted in its written observations, in a situation in which the damage is as yet insufficiently manifest, the injured person might be dissuaded from bringing a costly legal action, while months or years later that person would have been better able to define the scope of the damage. Moreover, if the injured person brings an action while the damage is still limited and his or her medical condition is still evolving, he or she risks receiving partial compensation. (74)

117.With regard to the objective of the rules of which Article 10 of Directive 85/374 forms part, it is apparent from the ninth recital of that directive that consumer protection requires compensation for death and personal injury. The injured person must be effectively able to exercise his or her right to claim full and proper compensation for the damage suffered.

118.The German Government argued that the three-year limitation period must begin on the date when the damage becomes apparent and the injured person, including the person suffering from progressive damage, becomes aware of the manifestation of the damage. The situation of progressive harm is addressed under German legislation, as already noted above, by the possibility of bringing a declaratory action. (75) The German Government submitted that that course of action is applicable in the case of subsequent damage which can ‘typically’ be expected. However, in the case of unpredictable ‘atypical’ damage, a new limitation period begins to run from the moment the claimant became aware of the damage.

119.The Commission maintained in its written observations that it is not inconceivable that under certain national legal systems it might be possible for injured persons to ask for a stay of the proceedings until such time as the damage is sufficiently known. However, the Commission acknowledged that such a possibility does not exist in all Member States.

120.The different approaches that may exist in national laws illustrate that there can be divergent degrees of protection of the injured persons’ ability to claim damages, depending on national procedural law, whereas the limitation period is intended to be uniform. Moreover, requiring the injured person gradually to increase the amount of compensation claimed on the basis of the additional harm resulting from the harmful event can be costly and time-consuming, and is therefore liable to undermine the full effectiveness of the right to compensation. (76)

121.In order to ensure uniform interpretation of the starting date of the limitation period and the effectiveness of the right of an injured person suffering from a progressive disease to claim compensation, that date cannot be considered to run before stabilisation of the harm suffered. The date of stabilisation is determined on the basis of medical evidence.

122.Following this interpretation of Article 10(1) of Directive 85/374, it must be accepted that, in the situation of an evolving disease, the three-year limitation period does not start to run until the date of stabilisation of the damage, even if the damage appeared on a previous date.

123.That interpretation of Article 10 of Directive 85/374 must be read in the light of my response to the second question addressed in the present Opinion. Indeed, in order to preserve the effectiveness of Article 10 with regard to persons suffering from a progressive disease, the expiry period laid down in Article 11 must be determined in such a way as to take into account their particular situation and their right to an effective remedy under Article 47 of the Charter.

124.In the light of the foregoing, I take the view that Article 10(1) of Directive 85/374 must be interpreted as meaning that, in the situation of a progressive disease, the three-year limitation period established in that provision starts to run on the date of stabilisation of the damage, defined as the moment from which, according to medical evidence, the condition of the injured person is no longer evolving.

125.In view of the foregoing, I propose that the Court should answer the questions referred by the cour d’appel de Rouen (Court of Appeal, Rouen, France) as follows:

(1)Article 13 of 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, read in the light of the judgment of the Court of Justice of 25 April 2002, González Sánchez (C‑183/00, EU:C:2002:255),

must be interpreted as meaning that the person injured by a defective product may seek compensation for his or her injury from the producer under a national general system of fault-based liability, to the extent that such a system is not based exclusively on the defectiveness of the product. The fault may consist, in particular, in maintaining a product in circulation despite the producer being aware of its defectiveness or in a failure to exercise vigilance with respect to the risks associated with the product, despite the producer having been notified of those risks.

(2)Article 11 of Directive 85/374, under which the rights conferred on an injured person by that directive are extinguished on expiry of a period of 10 years from the date on which the harmful product was put into circulation,

is invalid in the light of Article 47 of the Charter of Fundamental Rights of the European Union, in so far as its application has the effect of extinguishing the right to claim compensation of injured persons suffering from a progressive disease who, according to medical evidence, due to the progressive nature of their medical condition, cannot fully evaluate the damage caused to them and have therefore been unable to initiate proceedings against the producer within that period, thereby depriving those persons of their right of access to a court.

(3)Article 10(1) of Directive 85/374

must be interpreted as meaning that, in the situation of a progressive disease, the three-year limitation period established in that provision starts to run on the date of stabilisation of the damage, defined as the moment from which, according to medical evidence, the condition of the injured person is no longer evolving.

—

Original language: English.

The name of the present case is a fictitious name. It does not correspond to the real name of any of the parties to the proceedings.

Council Directive 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), as amended by Directive 1999/34/EC of the European Parliament and of the Council of 10 May 1999 (OJ 1999 L 141, p. 20) (‘Directive 85/374’).

Before the adoption of Directive (EU) 2024/2853 of the European Parliament and of the Council of 23 October 2024 on liability for defective products and repealing Directive 85/374 (OJ L 2024/2853).

White, F., ‘Directive 85/374/EEC concerning liability for defective products: In the name of harmonisation, the internal market and consumer protection’, in Giliker, P. (ed.), Research Handbook on EU Tort Law, Edward Elgar, Cheltenham, Northampton, 2017.

Cousy, H., ‘Chapter 3. Consumer protection through product liability. Theme I. Level and scope of harmonisation of the directive – Survival of national product liability regimes’, in Terryn, E., Straetmans, G. and Colaert, V. (eds), Landmark Cases of EU Consumer Law – In Honour of Jules Stuyck, Intersentia, Cambridge, Antwerp, Portland, 2013, pp. 291 to 306, at p. 296.

Judgment of 21 December 2011, Dutrueux (C‑495/10, EU:C:2011:869, paragraph 20).

Binon, J.-M., ‘La responsabilité du fait des produits défectueux : Les vices cachés de l’harmonisation européenne’, in Van Schoubroeck, C., Devroe, W., Geens, K. and Stuyck, J. (eds.), Over Grenzen – Liber Amicorum Herman Cousy, Intersentia, Antwerpen, Cambridge, 2011, pp. 591 to 603.

Judgments of 15 November 2023, Nos 22-21.174, 22-21.178, 22-21.179 and 22-21.180. Those judgments were delivered in the context of appeals brought by victims of the pharmaceutical product ‘Médiator’.

The issue of whether the alleged fault can actually be established in the circumstances of the specific case is a matter for the referring court.

See, to that effect, judgment of 10 June 2021, KRONE – Verlag (C‑65/20, EU:C:2021:471, paragraph 31). The concept of the ‘producer’ is defined in Article 3 of Directive 85/374.

Taschner, H.C., ‘Product liability: Basic problems in a comparative law perspective’, in Fairgrieve, D. (ed.), Product Liability in Comparative Perspective, Cambridge University Press, Cambridge, 2005, pp. 155 to 166, at p. 161 (emphasis added).

Judgment of 10 June 2021, KRONE–Verlag (C‑65/20, EU:C:2021:471, paragraph 33).

See, to that effect, judgment of 5 March 2015, Boston Scientific Medizintechnik (C‑503/13 and C‑504/13, EU:C:2015:148, paragraph 39).

Judgment of 29 May 1997, Commission v United Kingdom (C‑300/95, EU:C:1997:255, paragraph 27).

See, to that effect, Van Dam, C.C., ‘Dutch case-law on the EU Product Liability Directive’, in Fairgrieve, D. (ed.), pp. 126 to 137, at p. 128.

Judgments of 25 April 2002, Commission v France (C‑52/00, EU:C:2002:252, paragraph 24), and of 21 December 2011, Dutrueux (C‑495/10, EU:C:2011:869, paragraph 20).

Judgment of 21 December 2011, Dutrueux (C‑495/10, EU:C:2011:869, paragraph 21).

The judgment in González Sánchez, paragraph 30.

The judgment in González Sánchez, paragraph 31.

See, to that effect, Opinion of Advocate General Tesauro in Commission v United Kingdom (C‑300/95, EU:C:1997:35, point 16).

Judgment of 25 April 2002, Commission v France.

In French, ‘obligation de suivi’.

Judgment of 25 April 2002, Commission v France (C‑52/00, EU:C:2002:252, paragraph 47).

Judgment of 25 April 2002 (C‑52/00, EU:C:2002:252).

Judgment of 2 December 2009, Aventis Pasteur (C‑358/08, EU:C:2009:744, paragraph 37).

See, to that effect, judgment of 2 December 2009, Aventis Pasteur (C‑358/08, EU:C:2009:744, paragraphs 38 and 43).

Ibid., paragraph 39.

Ibid., paragraph 40.

Ibid., paragraph 41.

Ibid., paragraph 42.

See, to that effect, judgment of 2 December 2009, Aventis Pasteur (C‑358/08, EU:C:2009:744, paragraph 46).

Judgment of 10 May 2001, Veedfald (C‑203/99, EU:C:2001:258, paragraph 27).

Judgment of 10 September 2024, KS and Others v Council and Others (C‑29/22 P and C‑44/22 P, EU:C:2024:725, paragraph 67 and the case-law cited).

See, to that effect, judgments of 6 October 2020, État luxembourgeois (Right to bring an action against a request for information in tax matters) (C‑245/19 and C‑246/19, EU:C:2020:795, paragraphs 55 and 56), and of 17 November 2022, Harman International Industries (C‑175/21, EU:C:2022:895, paragraph 32).

For an examination of the limitation periods laid down by national legislation for consumer law proceedings, see judgments of 10 June 2021, BNP Paribas Personal Finance (C‑776/19 to C‑782/19, EU:C:2021:470, paragraph 30), and of 8 September 2022, D.B.P. and Others (Mortgage loans denominated in foreign currency) (C‑80/21 to C‑82/21, EU:C:2022:646, paragraph 99).

Judgment of 14 July 2022, Parliament v Council (Seat of the European Labour Authority) (C‑743/19, EU:C:2022:569, paragraph 33 and the case-law cited).

See, to that effect, judgments of 24 February 2022, SC Cridar Cons (C‑582/20, EU:C:2022:114, paragraph 50), and of 8 December 2022, Orde van Vlaamse Balies and Others (C‑694/20, EU:C:2022:963, paragraph 60).

See, to that effect, judgment of 29 March 2022, Getin Noble Bank (C‑132/20, EU:C:2022:235, paragraph 116).

See, to that effect, judgment of 2 February 2021, Consob (C‑481/19, EU:C:2021:84, paragraph 37 and the case-law cited).

Judgment of 24 February 2022, SC Cridar Cons (C‑582/20, EU:C:2022:114, paragraph 50 and the case-law cited).

Judgment of 8 December 2022, Orde van Vlaamse Balies and Others (C‑694/20, EU:C:2022:963, paragraph 34).

See, to that effect, judgment of 6 October 2020, État luxembourgeois (Right to bring an action against a request for information in tax matters) (C‑245/19 and C‑246/19, EU:C:2020:795, paragraph 66).

See point 33 et seq. of the present Opinion.

See my analysis under the first question referred.

Fairgrieve, D. et al., ‘Product Liability Directive’, in Machnikowski, P. (ed.), European Product Liability: An Analysis of the State of the Art in the Era of New Technologies, Intersentia, Cambridge, 2016, p. 90.

See Havu, K. and Havu, T., ‘The “long-stop” extinguishment rule in EU product liability’, Journal of European Consumer and Market Law, Vol. 13, Issue 4, 2024, pp. 162 to 170, at p. 163.

ECtHR, 11 March 2014, CE:ECHR:2014:0311JUD005206710. See also ECtHR, 13 February 2024, Jann-Zwicker and Jann v. Switzerland, CE:ECHR:2024:0213JUD000497620.

The judgment in Howald Moor and Others v. Switzerland, § 74.

Ibid., § 78.

Ibid., § 79.

ECtHR, 13 February 2020, CE:ECHR:2020:0213JUD002513716.

Ibid., § 55.

Ibid., § 55.

Ibid. § 55.

Provided in Paragraph 256 of the Zivilprozessordnung (German Civil Procedural Code).

See, Havu, K. and Havu, T., footnote 46, op. cit., p. 162, according to whom ‘the existence of an unconditional [extinguishment provision] may have the unintended consequence of encouraging claimants to file before they have obtained all the information that they need, … which can produce inefficiency and undermine the predictability of case outcomes’.

See ECtHR, 13 May 2024, Jann-Zwicker and Jann v. Switzerland, § 65 with further references.

See, to that effect, judgment of 8 December 2022, Orde van Vlaamse Balies and Others (C‑694/20, EU:C:2022:963, paragraph 41 and the case-law cited).

See, to that effect, judgment of 22 April 2021, Profi Credit Slovakia (C‑485/19, EU:C:2021:313, paragraph 57 and the case-law cited).

See, to that effect, judgment of 2 December 2009, Aventis Pasteur (C‑358/08, EU:C:2009:744, paragraph 46).

ECtHR, 13 February 2020, Sanofi Pasteur v. France, CE:ECHR:2020:0213JUD002513716, § 50.

Ibid., § 52 and the case-law cited.

See, to that effect, judgment of 25 April 2002, Commission v France (C‑52/00, EU:C:2002:252, paragraph 29).

See points 48 to 50 of the present Opinion.

Judgment of 2 December 2009, Aventis Pasteur (C‑358/08, EU:C:2009:744, paragraph 42).

Havu, K. and Havu, T., footnote 46, op. cit., p. 167. See also Howells, G.G., ‘Product liability – A history of harmonisation’, in Fairgrieve, D. (ed.), Product Liability in Comparative Perspective, footnote 11, op. cit., pp. 202 to 217, at p. 210, who points out that the 10-year limitation period ‘could …be seen as a potential source of injustice’.

See point 88 of the present Opinion.

Directive of the European Parliament and of the Council of 23 October 2024 on liability for defective products and repealing Council Directive 85/374/EEC (OJ L 2024/2853).

According to the first sentence of Article 21 of Directive 2024/2853: ‘Directive [85/374] is repealed with effect from 9 December 2026. However, it shall continue to apply with regard to products placed on the market or put into service before that date.’ It follows from that provision that Directive 2024/2853 does not apply with regard to the vaccine in the main proceedings that was administered more than two decades ago.

Judgment No 22-18.914 of the Cour de cassation, Première Chambre Civile (First Civil Chamber of the Court of Cassation), of 5 July 2023. That judgment reflects the settled case-law of the Cour de cassation (Court of Cassation), according to which the date on which the victim knew or should have known the damage is the date of the stabilisation of the damage. See, for instance, judgment No 15-20.022 of the Cour de cassation, Première Chambre Civile (First Civil Chamber of the Court of Cassation), of 15 June 2016.

Judgment of 8 April 2025, European Public Prosecutor’s Office (Judicial review of procedural acts) (C‑292/23, EU:C:2025:255, paragraph 51 and the case-law cited).