Opinion of the Advocate General — ECLI:EU:C:2025:467
Date: 2025-06-19
Language of the case: French
Procedure: Reference for a preliminary ruling
Origin: France

Summary C-338/24 – 1 
Case C-338/24 
Summary of the request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged:  
7 May 2024 
Referring court:  
Cour d’appel de Rouen (France) 
Date of the decision to refer:  
25 April 2024 
Appellant:  
LF 
Respondent:  
SANOFI PASTEUR S.A. 
  
1. Subject matter of the main proceedings: 
1 LF, who was born on 7 January 1980, was vaccinated on 20 March 2003 against 
diphtheria, tetanus and poliomyelitis with the Revaxis vaccine, manufactured by 
the Sanofi Pasteur laboratory. 
2 LF claims that, from 2004 onwards, she suffered various symptoms, infections 
and pain (affecting her digestive system, throat, shoulder, arm, hands, neck and 
causing urinary infections, lower back pain and hair loss) and, from December 
2005 onwards, took repeated periods of sick leave from work. 
3 Various medical examinations were carried out, 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. This macrophagic myofasciitis caused her to be admitted to 
hospital from 2 to 5 April 2013. 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING – CASE C-338/24 
 
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4 On 2 June 2015, LF referred her case to the Commission de Conciliation et 
d’Indemnisation des Accidents Médicaux (Conciliation and Compensation Board 
for Medical Accidents), which ordered an expert report to be drawn up. 
5 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 Board dismissed her case on 11 January 2017. 
6 By documents dated 17 and 23 June 2020, LF initiated proceedings against Sanofi 
Pasteur, inter alia, before the Tribunal Judiciaire d’Alençon (Court of Alençon, 
France), seeking compensation for the injuries suffered following her vaccination. 
Her claims relied on liability for defective products and also on fault-based 
liability. 
7 By order of 10 June 2021, the judge preparing the case for trial at the Court of 
Alençon found that LF’s action against Sanofi was time-barred and dismissed her 
claims. 
8 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. 
9 By judgment of 5 July 2023, the Cour de cassation (Court of Cassation, France) 
essentially set aside the judgment of the Court of Appeal of Caen and remitted the 
case to the Cour d’appel de Rouen (Court of Appeal, Rouen, France). 
10 On 18 September 2023, LF brought proceedings before the referring court. 
11 This case raises several questions of interpretation 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. 
12 First of all, a question arises as to the exclusive nature of the system of rules 
governing liability for defective products. In other words, can this system of rules 
be applied concurrently with another system, such as that pertaining to fault-based 
liability, and is it therefore possible to bring an action relying on both of those 
systems, as LF has done? Next, as regards the rules governing liability for 
defective products, the question arises as to whether the 10-year limitation period 
for bringing an action provided for in Article 11 of Directive 85/374 infringes the 
right of access to a court. Lastly, there is a question of interpretation of the three-
year limitation period for bringing a civil liability action for defective products, 
laid down by Article 10 of the directive, and more particularly of the date on 
which that period starts to run, particularly in the case of a complex progressive 
medical condition such as that of LF.  
SANOFI PASTEUR 
 
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2. Legal framework: 
European Union law 
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 
13 Article 10 provides as follows: 
‘1. 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. 
…’ 
14 Article 11 provides as follows: 
‘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.’ 
15 Article 13 provides as follows: 
‘This Directive shall 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 this Directive is notified.’ 
Charter of Fundamental Rights of the European Union 
16 Article 52 of the Charter of Fundamental Rights provides as follows: 
‘1. Any limitation on the exercise of the rights and freedoms recognised by this 
Charter must be provided for by law and respect the essence of those rights and 
freedoms. Subject to the principle of proportionality, limitations may be made 
only if they are necessary and genuinely meet objectives of general interest 
recognised by the Union or the need to protect the rights and freedoms of others. 
2. Rights recognised by this Charter for which provision is made in the 
Treaties shall be exercised under the conditions and within the limits defined by 
those Treaties. 
3. In so far as this Charter contains rights which correspond to rights 
guaranteed by the Convention for the Protection of Human Rights and 
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Fundamental Freedoms, the meaning and scope of those rights shall be the same 
as those laid down by the said Convention. This provision shall not prevent Union 
law providing more extensive protection.’ 
17 Article 47 of the Charter provides as follows: 
‘Right to an effective remedy and to a fair trial 
Everyone whose rights and freedoms guaranteed by the law of the Union are 
violated has the right to an effective remedy before a tribunal in compliance with 
the conditions laid down in this Article. 
Everyone is entitled to a fair and public hearing within a reasonable time by an 
independent and impartial tribunal previously established by law.  
…’ 
French law 
Code civil (Civil Code) 
18 Article 1245-16 of the Civil Code, which transposes Article 10 of Directive 
85/374, provides as follows: 
‘A limitation period of three years shall apply to proceedings for the recovery of 
damages as provided for under this Title. The limitation period shall begin to run 
from the day on which the claimant became aware, or should reasonably have 
become aware, of the damage, the defect and the identity of the producer.’ 
19 Article 1245-15, which transposes Article 11 of Directive 85/374, provides as 
follows: 
‘Except where the producer is at fault, the producer’s liability pursuant to the 
provisions of this Chapter shall be extinguished 10 years from the date on which 
the actual product which caused the damage was put into circulation, unless the 
injured person has in the meantime instituted proceedings.’ 
20 Article 1245-17, which transposes Article 13 of Directive 85/374, provides as 
follows: 
‘The provisions of this Chapter shall 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. 
The producer shall remain liable for the consequences of its own fault and that of 
persons for whom it is responsible.’ 
21 Article 1240 of the Civil Code provides as follows: 
SANOFI PASTEUR 
 
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‘Any act whatsoever of a person which causes harm to another person obliges the 
person through whose fault it occurred to make reparation for it.’ 
3. The essential arguments of the parties: 
The appellant 
The exclusive nature of the system of rules governing liability for defective 
products 
22 LF submits that she has a cause of action against Sanofi Pasteur both on the basis 
of liability for defective products pursuant to Article 1245 et seq. of the Civil 
Code and on the basis of fault-based liability pursuant to Articles 1240 and 1241 
of that code. Despite numerous warnings about the effects of its aluminium-
containing vaccine, Sanofi Pasteur took no action and failed to carry out any 
research or monitoring following the launch of Revaxis which would have 
enabled her to make an informed decision whether to have the vaccination, 
bearing in mind that the vaccination in question was not compulsory.  
23 Sanofi Pasteur therefore committed a fault, which is a separate issue from any 
safety defect affecting the product. 
The expiry of the limitation period for LF’s action based on liability for defective 
products 
24 LF submits that the 10-year limitation period for bringing an action provided for 
in Article 1245-15 of the Civil Code conflicts with the provisions of Article 6(1) 
of the European Convention for the Protection of Human Rights and Fundamental 
Freedoms by depriving her of her right of access to a court in view of the fact that 
her medical condition is a complex and progressive one.  
25 Directive 85/374, which was transposed into French law by Article 1245 et seq. of 
the Civil Code, is not suited to matters of health or compensation for physical 
injury. The period of 10 years can only start to run on the day when LF had 
objective knowledge of her rights, which in the present case was on 17 October 
2016, being the date on which the expert report was submitted. 
The limitation period governing LF’s action 
26 LF submits that the three-year limitation period laid down in Article 1245-16 of 
the Civil Code only started to run on the date of knowledge of the damage and, 
given that she suffered physical injury resulting from a progressive medical 
condition, that date was the date of stabilisation of her condition. 
The respondent 
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The exclusive nature of the system of rules governing liability for defective 
products 
27 Sanofi Pasteur maintains that myofasciitis is a localised inflammatory reaction of 
muscle tissue at the site of a vaccine injection and that the experts never 
established any link between the complaints allegedly suffered by LF and her 
Revaxis vaccination. The opinions relied on by LF in support of her claims to the 
contrary represent a minority view. 
28 The fault which LF alleges against Sanofi Pasteur, amounting to a lack of 
vigilance or failure to monitor its product after launch, is not a separate issue from 
the alleged safety defect raised under the system of liability for defective products, 
the only type of liability relevant to the present case; LF’s claim founded on fault-
based liability is thus inadmissible. 
29 Sanofi Pasteur maintains that, according to the case-law of the Court of Justice of 
the European Union, only the rules governing liability for defective products are 
applicable because the action being pursued is for a breach of safety obligations, 
that system of rules being a matter of public policy. 
30 The Court of Cassation’s case-law in this area, arising in particular from various 
judgments of 15 November 2023, requires a reference for a preliminary ruling on 
this point. 
The expiry of the limitation period for LF’s action based on liability for defective 
products 
31 Any liability on the part of Sanofi Pasteur has been extinguished because more 
than 10 years have passed since its vaccine was first marketed. LF was vaccinated 
on 20 March 2003 and the medical complaints which she relies on appeared 
within the 10-year period for bringing an action. That provision derives from 
Article 11 of Directive 85/374, which is compatible with the European 
Convention for the Protection of Human Rights and Fundamental Freedoms; it 
was transposed by Article 1245-15 of the Civil Code, and it applies to vaccines 
and healthcare products. 
The limitation period governing LF’s action 
32 Sanofi Pasteur argues that LF’s action is time-barred pursuant to Article 1245-16 
of the Civil Code which refers not to the date of stabilisation but to the date on 
which the victim became aware of the damage. It notes that LF does not have a 
progressive medical condition according to the experts who examined her, that 
those experts determined a stabilisation date of 20 September 2016 and that LF 
does not dispute that stabilisation date. 
SANOFI PASTEUR 
 
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4. Assessment by the Court of Appeal of Rouen 
The exclusive nature of the system of rules governing liability for defective 
products 
33 By judgment of 25 April 2002, González Sánchez (C-183/00, EU:C:2002:255), 
the Court of Justice held as follows: 
‘25 Accordingly, the margin of discretion available to the Member States in 
order to make provision for product liability is entirely determined by the 
Directive itself and must be inferred from its wording, purpose and structure. 
26 In that connection it should be pointed out first that, as is clear from the 
first recital thereto, the purpose of the Directive in establishing a harmonised 
system of civil liability on the part of producers in respect of damage caused by 
defective products is to ensure undistorted competition between traders, to 
facilitate the free movement of goods and to avoid differences in levels of 
consumer protection. 
27 Secondly, it is important to note that unlike, for example, Council Directive 
93/13/EEC of 5 April 1993 on unfair terms in consumer contracts (OJ 1993 L 95, 
p. 29), the Directive contains no provision expressly authorising the Member 
States to adopt or to maintain more stringent provisions in matters in respect of 
which it makes provision, in order to secure a higher level of consumer 
protection. 
28 Thirdly, the fact that the Directive provides for certain derogations or 
refers in certain cases to national law does not mean that in regard to the matters 
which it regulates harmonisation is not complete. 
29 Although Articles 15(1)(a) and (b) and 16 of the Directive permit the 
Member States to depart from the rules laid down therein, the possibility of 
derogation applies only in regard to the matters exhaustively specified and it is 
narrowly defined. Moreover, it is subject inter alia to conditions as to assessment 
with a view to further harmonisation, to which the penultimate recital in the 
preamble expressly refers. An illustration of progressive harmonisation of that 
kind is afforded by Directive 1999/34/EC of the European Parliament and of the 
Council of 10 May 1999 amending Council Directive 85/374/EEC (OJ 1999 
L 141, p. 20), which by bringing agricultural products within the scope of the 
Directive removes the option afforded by Article 15(1)(a) thereof. 
30 In those circumstances Article 13 of the Directive cannot be interpreted as 
giving the Member States the possibility of maintaining a general system of 
product liability different from that provided for in the Directive. 
31 The reference in Article 13 of the Directive to the rights which an injured 
person may rely on 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 the 
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Directive, which in Article 4 enables the victim to seek compensation where he 
proves damage, the defect in the product and the causal link between that defect 
and the damage, 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. 
32 Likewise the reference in Article 13 to the rights which an injured person 
may rely on under a special liability system existing at the time when the Directive 
was notified must be construed, as is clear from the third clause of the 13th recital 
thereto, as referring to a specific scheme limited to a given sector of production 
(see judgments of today in Case C-52/00 Commission v France [2002] ECR I-
0000, paragraphs 13 to 23, and Case C-154/00 Commission v Greece [2002] 
ECR I-0000, paragraphs 9 to 19). 
33 Conversely, a system of producer liability founded on the same basis as 
that put in place by the Directive and not limited to a given sector of production 
does not come within any of the systems of liability referred to in Article 13 of the 
Directive. That provision cannot therefore be relied on in such a case in order to 
justify the maintenance in force of national provisions affording greater 
protection than those of the Directive. 
34 The reply to the question raised must therefore be that Article 13 of the 
Directive must be interpreted as meaning that the rights conferred under the 
legislation of a Member State on the victims of damage caused by a defective 
product under a general system of liability having the same basis as that put in 
place by the Directive may be limited or restricted as a result of the Directive's 
transposition into the domestic law of that State.’ 
34 Up until 15 November 2023, the Court of Cassation’s position was that, although 
the system of rules governing liability for defective products that are neither 
intended for, nor put to, professional use did not preclude the application of other 
systems of contractual or non-contractual liability, that was conditional on those 
systems being based on grounds other than that of a safety defect in the product at 
issue, such as fault or a warranty in respect of latent defects. 
35 By several judgments of 15 November 2023 (22-21.174, 178, 179, 180), the Court 
of Cassation held that ‘the victim of damage attributed to a defective product may 
bring a liability action against the producer on the basis of the second of those 
provisions [Article 1240 of the Civil Code] if he or she can establish that the 
damage resulted from a fault committed by the producer, such as allowing the 
product to remain in circulation despite knowing that it was defective or failing in 
its duty to exercise vigilance with respect to the risks associated with the product.’ 
36 The question therefore arises as to how the rule established by Article 13 of 
Directive 85/374 should be interpreted. That is the subject of the first question 
referred by the Court of Appeal for a preliminary ruling. 
SANOFI PASTEUR 
 
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The expiry of the limitation period for LF’s action based on liability for defective 
products 
37 The ground put forward by LF seeks to challenge the compatibility of 
Article 1245-15 of the Civil Code, which transposes a European directive, with 
the European Convention for the Protection of Human Rights and Fundamental 
Freedoms. A national court is thus being tasked with assessing the compatibility 
of a European directive, which has supranational normative value under 
Article 288 of the Treaty on the Functioning of the European Union, with 
Article 47 of the Charter of Fundamental Rights. 
38 Since neither the Treaty on the Functioning of the European Union, nor the 
Charter of Fundamental Rights, nor the European Convention for the Protection of 
Human Rights and Fundamental Freedoms lays down any rules governing 
conflicts between the two legal systems, the Court of Justice must be consulted on 
this point. That is the subject of the second question referred by the Court of 
Appeal for a preliminary ruling. 
The limitation period governing LF’s action 
39 In that regard, the Court of Appeal refers to Article 10 of Directive 85/374 and to 
Article 1245-16 of the Civil Code, which transposes Article 10. 
40 The Court of Appeal recalls that the Court of Cassation, in its judgment remitting 
the case to the lower court, held that, under Article 1245-16 of the Civil Code, 
proceedings for the recovery of damages brought on the basis of Article 1245 et 
seq. of that code are subject to a limitation period of three years from the date on 
which the claimant became aware, or should have become aware, of the damage, 
the defect and the identity of the producer. In that regard, the Court of Cassation 
held that, in a case of physical injury, the date of becoming aware of the damage 
should be understood to mean the stabilisation date, as it is only then that the 
claimant can measure the extent of his or her damage. In the case of a progressive 
medical condition, which makes it impossible to determine a stabilisation date, the 
time limit laid down by the aforementioned provision cannot start to run. 
41 In that regard, the Court of Cassation criticised the Court of Appeal of Caen for 
having declared LF’s claims for defective product liability to be inadmissible on 
the grounds that, in 2013, LF had undergone many examinations and assessments 
in relation to her various medical complaints, most of which had appeared 
between 2004 and 2007, and that she therefore had detailed knowledge of the 
damage no later than 15 October 2013, the date of her last medical examination. 
42 The Court of Cassation found that, in reaching that conclusion, without 
investigating whether LF’s damage had stabilised and, if it had not, whether her 
condition was  progressive, where stabilisation was impeded, the decision of the 
Court of Appeal Caen lacked any legal basis. 
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43 According to the Court of Appeal of Rouen, the interpretation given to 
Article 1245-16 of the Civil Code, which transposes Article 10 of Directive 
85/374, means that the ‘day on which the claimant became aware, or should have 
become aware, of the damage’ is the stabilisation date. Since stabilisation can be 
defined as the moment from which the condition of the victim of a physical injury 
is no longer progressive, it follows that, in the case of a progressive medical 
condition resulting from a defective product, the time limit laid down by those two 
provisions cannot start to run. 
44 The question therefore arises as to how the rule established by Article 10 of 
Directive 85/374 is to be interpreted, which requires a reference to the Court of 
Justice on this point. This is the context for the third question referred by the 
Court of Appeal for a preliminary ruling. 
5. Questions referred for a preliminary ruling: 
45 The Court of Appeal refers the following questions to the Court of Justice for a 
preliminary ruling: 
(1) Must Article 13 of Directive 85/374/EEC of 25 July 1985, as interpreted by 
the judgment of 25 April 2002 (Maria Victoria Gonzalez Sanchez v Medicina 
Asturiana SA. C-183/00), 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/EEC of 25 July 1985, 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 of 
Fundamental Rights of the European Union in that it deprives a victim suffering 
from a progressive injury caused by a defective product from the right of access to 
a court? 
(3) Can Article 10 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, 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 
SANOFI PASTEUR 
 
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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?