European Union Product Liability Law and its (Uncertain) Future – Some Thoughts on LF v. Sanofi Pasteur case

Magdalena Tulibacka, Director of the Center of International and Comparative Law, Visiting Assistant Professor of Practice, Emory Law School 

Photo credit: Pexels, via Wikimedia commons

 

It is difficult to overstate the importance of the forthcoming judgment of the European Court of Justice (ECJ) in LF v. Sanofi Pasteur.¹ The judgment, if it follows the recent opinion of ECJ’s Advocate General (AG) Medina,² is likely to create a major shift in the system of liability established by the EU’s Product Liability Directive (PLD).³

Three questions referred to the ECJ by the Court of Appeal of Rouen arose in a case involving a vaccine produced by Sanofi Pasteur. The case concerns a type of a health injury referred to by the French court as a progressive condition.⁴ The claimant started experiencing pain and other health complaints after being vaccinated. Her condition kept getting progressively worse. Even accounting for the continued worsening of LF’s health, however, it is somewhat puzzling how long it took for the case to reach the courts.⁵ It appears that LF waited 11 years from the time of appearance of first symptoms and 7 years from the diagnosis of her condition to commence proceedings before a compensation scheme, which rejected the claim because of lack of causal link,⁶ and 3 further years to bring a lawsuit against Sanofi.⁷ As held by two French courts considering this case, following Article 1245-15 and 1245-16 of Code Civil (implementing the provisions of the PLD on limitation periods), LF’s actions were thus time-barred.⁸

The Cour de Cassation, however, decided to refer the case back to a Court of Appeal of Rouen to test some of the recent arguments that appeared in its own jurisprudence and in judgments of other courts against the application of limitation periods in other domestic regimes when progressive conditions are concerned.⁹

In order to enable LF’s case against Sanofi to proceed, the Court of Appeal asked first of all whether a potential victim of a defective product could bring a case against its manufacturers based on fault in lack of vigilance and lack of information about the risks of using the products. This is very difficult to reconcile with the PLD - a system that does not allow any other general product liability system functioning on the same basis to exist. The primary reason that this question arose in the case seems to be that French law has more generous time limits for general tort liability claims, and thus LF could still arguably bring her claim against Sanofi.

The two remaining questions relate to the system of liability established by PLD and implemented into French law, and specifically its limitation periods and their application in cases of progressive diseases. The questions can be summarized as follows:

Does the PLD’s 10-year long stop period comply with the right to an effective remedy as provided in Article 47 of the EU’s Charter of Fundamental Rights,¹⁰ when it applies to cases of progressive conditions?

Does the Directive allow for the 3-year limitation period to start, in cases of progressive injuries, when the injury or condition has stabilized, not when the claimant knew or should have known about it, as indicated in PLD?

These questions push the boundaries of what the system of the Directive established. With its strict liability for property damage, personal injury and death caused by defective products, the PLD introduced one of the world’s most influential and comprehensive product liability systems. The Directive aims to be a complete system of liability rules, carefully balancing the variety of interests involved: the interests of victims of defective products, the industry, and even society as a whole. Recently, the PLD experienced a major overhaul, and a new Directive was enacted, bringing the European product liability law into the digitalized, increasingly complex market reality.¹¹ The new rules are not yet in force and do not apply in the case at hand, but they do reflect the current consensus on the whole system. The changes related to limitation periods will be described below.

The Directive continues to rely on national laws of EU Member States for interpretation and application of major elements of liability, such as defect, damage, and causal link. It also co-exists with other national contractual and non-contractual liability systems as well as compensation schemes for redress of damage caused by defective products. It is at this juncture – the interaction with the national systems of laws and remedies – that many questions arise, this case being a good example.

In response to the French court’s questions, the AG suggests that the ECJ ought to conclude as follows:

-          Victims of defective products can bring actions against the producers of these products using national tort-based, fault-based liability, as long as the alleged fault consists of factors not exclusively related to defectiveness of the product (like failures in vigilance).¹²

-          The ten-year long stop introduced in the Directive is invalid in the light of Article 47 of the EU’s Charter of Fundamental Rights, ‘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’.¹³

‘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.’¹⁴

For some context: the French system continues to challenge the maximum harmonization the PLD was meant to ensure. As regards the implementation of the PLD, France was reprimanded by the ECJ for late and then improper implementation and needed to amend its law.¹⁵

Further, the French tort liability system, and to some extent even its contractual liability, historically presented a more attractive option for victims of defective products.16 The French product liability law was developed by courts in the overall consumer-friendly climate, where the key role of liability rules was for victims of defective products to be compensated, as mostly strict liability of manufacturers and suppliers.¹⁷ French courts were open to abandoning the requirement of proving fault, as well as to adopting presumptions of causation and defect in product liability cases – the approach that is not common among other EU Member States.¹⁸ As mentioned above, the general tort liability system in France provides more generous limitation periods as well. It is thus not difficult to understand why some victims may wish to resort to this general liability system instead of the one established by the implementation of the PLD.

 

Reflecting on question 1.

In reference to the interaction between the PLD and the national liability systems, the AG’s opinion reflects a unique conundrum. While the Directive was not meant to be the only system of liability where victims of defective products could recover compensation, it is the only system of objective (‘defect-based’)¹⁹ liability for such products. Within the scope of liability as set out by the Directive, its rules constitute the threshold and the ceiling. Article 13 PLD provides that the Directive does not affect any rights an injured person may have according to the rules of contractual and non-contractual liability or a special liability system. This provision was further elucidated in ECJ’s jurisprudence. In Gonzalez Sanchez the Court highlighted that liability systems based on other grounds: such as fault or a warranty in respect of hidden defects, could remain it operation.²⁰ In Commission v France, a general product liability system different from that provided by the Directive was held not permissible.²¹ According to Gonzalez Sanchez, as confirmed by the AG in the current case, the Directive is the exclusive source for cases where the liability follows a defective product (as defined by PLD) causing damage or injury a person.²² Fault is not relevant in this system. The notion of defect as provided by the Directive focuses on lack of safety.²³

The AG’s argument that resorting to general tort liability rules should be possible if it could be established that the defendant was at fault by failing in its vigilance duties, however, is not very convincing. If the essence of the defendant’s fault is lack of vigilance over the product and the alleged lack of reaction (perhaps by pulling the vaccine off the market), is not the lack of safety in the product the condition si ne qua non here? Safety and vigilance seem to be very closely tied in European law. Within the context of product liability, courts cannot deem that there was a failure in vigilance without also assessing whether there was a defect (lack of safety). The AG suggests that fault in this case consists of factors not exclusively related to defectiveness of the product.²⁴

But surely, monitoring of the product’s safety once it enters the market is a requirement that features heavily in European Union laws on product safety. Pharmaceutical products carry a uniquely stringent set of requirements as regards monitoring. Further, in the context of product liability, failure to warn of potential risks, rather than being some additional criterion or requirement, is a feature of defect. Even though the PLD does not recognize the US-style ‘boxing’ of types of defects (into manufacturing, failure to warn and design defects), those three types are widely recognized in literature and jurisprudence across the EU and beyond.

In my opinion, the AG’s recommendations in this matter do not comply with the text of the Directive and the nature and spirit of product liability law as established by it.

 

Reflecting on Questions 2 and 3:

Let us now move to the question of limitation periods under the Directive. Generally, legal systems distinguish two types of limitation periods:

-          What we can call ‘ordinary’ limitation periods - procedural in nature and often, in product liability cases, dependent on subjective discovery of the injury/damage and the person responsible or liable to redress it. This moment of subjective discovery is also when the cause of action accrues.

-          Long-stops (also referred to as preclusion, prescription, long-stop, or repose) - more substantive in nature (in some systems, such as the PLD, a long stop is referred to as a period after which the claimant’s rights are extinguished), and dependent on objective criteria, not on the subjective position/situation of the claimant.

Factors at play in the determination of these periods can be broadly classified into the following categories:

-          Substantive, constitutional and fundamental rights arguments: legal certainty and rule of law, finality, fair trial, access to justice and effective remedy,

-          Procedural and evidential arguments: effect of the passing of time on availability of evidence, and

-          Economic arguments – ‘closing the books’, calculation of risk and liability exposure, obtaining affordable insurance coverage.

In summary: determination of limitation and expiry periods is always a product of compromise between the plaintiff and the defendant interests, but also wider social interests in justice being done on the one hand and in encouraging progress and development of new products on the other hand. Such a compromise has been established in the PLD. It has remained in place till today and survived the comprehensive reform of the Directive in 2024, with some changes.

In the old PLD, claimants can bring product liability suits within 3 years from when they became aware, or should reasonably have become aware, of the damage, the defect and the identity of the producer. Further, the rights under the Directive expire 10 years from when the product was placed into circulation.²⁵ In the new PLD, the 3-year limitation period has been retained virtually unchanged. The 10-year long-stop is now called ‘expiry period’. It has also been retained largely unchanged (with the modification of the start of the period for substantially modified products). However, an exception was introduced where an injured person is not able to initiate proceedings within 10 years due to the latency of her injury. The period in such cases is extended to 25 years.

The French Court’s questions address both the limitation period and what is now called the expiry period. With regard to the latter, the question is whether its very existence is contrary to Article 47 of the EU Charter of Fundamental Rights as regards progressive conditions. The Charter, as part of the Treaties and thus primary EU law, can be the basis for a constitutional review by the ECJ of any legally binding EU measure. Any secondary EU law, including the PLD, which does not comply with its requirement that everyone whose rights guaranteed by EU law were violated should have access to an effective remedy (Article 47), can be declared at least partially void.

The opinion of the AG recommending exactly such an outcome should be looked at in the context of the views of the ECtHR. In its 2020 judgment in Sanofi v. France and in an earlier judgment in Howard Moor v Switzerland the ECtHR held that the long-stop violated the right to access to justice of victims who suffered from latent diseases.²⁶

The recent amendment of the PLD extending the expiry period to 25 years for latent conditions addresses these concerns, albeit unfortunately the new PLD does not provide a definition of latency leaving its determination to national law. It is possible that even this longer period may not always be sufficient, as certain products may well cause injuries and diseases with a much longer latency period than 25 years. Perhaps the period will need to be extended in the future for some latent conditions, but we are not ready to abandon it entirely. We are also not ready to leave the decision whether or not it applies to courts if the conditions are already present but, according to the claimant’s doctors, may not have stabilized. The long-stop (expiry period) constitutes one of the fundamental elements of the balance of consumer-business interests set out by the PLD. Any amendments to it will no doubt cause a push-back from the industry side and calls for rebalancing the whole system. Especially amendments that have their roots in undefined legal and medical concepts.

What is particularly concerning in the case at hand is that the AG is willing to allow the unique approach adopted by some French judiciary for progressive conditions to be used in cases based on the Product Liability Directive, potentially extending its effect across other EU Member States. The question of progressive injuries is itself problematic. Further, this approach focuses on an (as yet undefined) concept of ‘stabilization’.

I will now address both these concepts and their application to limitation periods.

Progressive conditions mean that the injury is known for some time, albeit not in its entirety. The French argument is that the claimant will not be able to assess the full extent of the damage while her condition keeps developing, and thus, no limitation period should be running until the claimant’s condition ‘stabilizes’.²⁷ The notion of a progressive condition or disease is not defined in the Directive. It is also unlikely that the ECJ would provide such a definition, as it is rather a medical and a case-specific term. Thus, the exact meaning would be determined by doctors within each EU state – and that’s what the AG seeks to avoid.

If one were to agree with the opinion of the AG addressing questions 2 and 3, it would mean that for progressive diseases the only limitation period is three years from the moment when the claimant’s doctors conclude that her condition has stabilized (as the ten-year period would be disapplied). The AG’s argument that an EU-level approach is needed in such cases and the response cannot be left to Member States, should be commended but what she suggests is, in my view, the wrong way to approach this.

It seems from the submissions by the German government in the case that the problems with the progressive diseases and the resulting limitations in access to remedy may well be a problem with the French system. While it is a fact that provisional damages are normally not available in civil law systems, such systems have other ways in which victims can bring suits before their injuries present themselves in their entirety (such as bringing declaratory actions). Suits can be brought while the claimant’s condition is developing, and courts can assess potential future damages as part of the compensation award. Additional suits can potentially be brought as follow-on actions when new conditions develop, or the existing condition worsens beyond what was initially predicted. The text of the AG’s opinion contains statements to the effect that French law, in contrast to other legal systems in the EU, does not allow claims for compensation of future damages or provisional damages. It seems to also indicate that the claimant may not be able to bring follow-on claims. If that is indeed the case, there is a significant systemic problem in French rules of damages. But a more likely answer is that, in France, there are options for assessing of future damages and taking them into account in the final determination of compensation amounts due to the claimant, and there are also possibilities for bringing follow-on claims.

The application and enforcement of substantive rights granted by EU law has always been dependent on national remedial and procedural rules, subject to the requirements of effectiveness and equivalence. Here this principle is applied backwards – the AG is allowing the perceived deficiencies in these national systems to cause the whole, carefully constructed compromise of PLD to be shaken. Would it not be a better idea for the ECJ to request that only French law is clarified in this respect, thus maintaining the coherence of the whole PLD system across the EU?

The French requirement that the limitation period does not start running until the claimant’s disease has ‘stabilized’, was already subject to a judgment by the ECtHR, where Sanofi challenged France alleging that Article 6.1 of the European Convention of Human Rights (right to fair trial) was violated. The ECtHR concluded that France was within the limits of the discretion (margin of appreciation) granted by the Convention when it allowed the limitation period to be approached in this way by its courts.²⁸ This judgment was issued in a different legal context – specifically one where the ECHR is known for granting the states-parties a certain margin of appreciation. Here, in the context of the EU PLD, the discretion is severely limited.

Keeping the start of the limitation period flexible and subject to the decision of the doctor and the court in each case to the extent suggested by the AG can potentially create uncertainty. It is problematic from the perspective of access to evidence, the question of who has the power to determine ‘stabilization’, and the rights of the defendants.²⁹ It can also lead to potentially undesirable consequences of depriving the victim of a defective product of access to a remedy. The way the start of the ordinary limitation periods is usually understood is that it means the cause of action accrued. If the cause of action does not accrue until the person’s condition ‘stabilizes’, could it not be argued that patients who do not wish to wait for this moment do not have a claim? Would this not deprive many victims of access to remedy for a potentially long time, and often for the rest of their life?

Another point worth noting is that if we allow victims of defective products to wait with bringing cases until their condition has stabilized, which can mean after their death, we may be leaving the defendants in a position where they are to expect lurking lawsuits, usually by families of people who died. Thus, if the ECJ were to adopt the AG’s suggestion in this respect, perhaps it would be advisable to introduce a notification requirement into the PLD for such situations, such as the one in the Payment Services Directive, recently interpreted by the ECJ.30 If we take the need for an effective remedy into account, it may be a more effective, and more proportionate, response to require the claimant to notify the defendant of their injury, even if the latter is still progressing. Such a step would provide the defendant with the knowledge of the claim and some level of clarity, as well as provide the claimant with the certainty that their claim will not be time barred. Further, the notification could provide an encouragement for the parties to settle.

 

Conclusions:

In spite of the recent comprehensive reform of the PLD, some very important parts of the European Union product liability system are by no means settled, thus creating uncertainty for potential plaintiffs and defendants. This comment cautions against following the AG’s opinion because, while it may assist the claimant (LF) in her case, it could create a destabilizing effect on the EU-wide product liability system. The AG’s recommendations in this case are a concern. In a reality where European legal systems - through their legislators and courts – continue to face difficult cases of injuries, they are bound to experiment, introduce new systems, new rules, and new ways of interpretation and application of the existing rules. Perhaps it is not realistic to expect that PLD will fully achieve its objective of harmonization, and PLD is playing ‘catch up’ with national systems – the latest reform is an example. But the system should remain stable, and such national experimentation can threaten this stability.

The arguments raised in this comment are particularly notable after the new EU Directive on Representative Actions came into force. Product liability cases can now be brought using a pan-EU representative procedure. With some major private international law issues still unresolved, there will be scope for forum shopping. If we allow national peculiarities to remain part of the product liability system to the extent suggested by the AG in LF v. Sanofi Pasteur, we increase the risk of forum shopping.

 

¹ Case C-338/24, LF v. Sanofi Pasteur SA, Request for a preliminary ruling from the Cour d’appel de Rouen (France) lodged on 7 Mary 2024, https://eur-lex.europa.eu/eli/C/2024/4716/oj/eng.

₂ Opinion of AG Medina delivered on 19 June 2025.

³ Council Directive 85/374/EEC on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products, OJ L 210, 7.8.1985, pp. 29-33, recently replaced by Directive (EU) 2024/2854 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, 18.11.2024; in the text of this comment: ‘PLD’ or ‘the Directive’ and ‘new PLD’ or ‘new Directive’.

⁴ No precise definition of such a progressive disease is provided, except for it being a condition that develops over a long period (para. 53 of the AG Opinion, see note 2).

⁵ LF received the Revaxis vaccine manufactured by Sanofi Pasteur in 2003. One explanation advanced in the case indicates that a residual amount of aluminum hydroxide (detected in LF’s body), used in certain vaccines, could have caused her condition.

⁶ The Board for Conciliation and Compensation for Medical Accidents is a French no-fault compensation scheme: Commission de Conciliation et d’Indemnisation des Accidents Medicaux (CCI). Her claim was rejected by CCI following an assessment by the expert appointed in the case who did not find a causal link.

⁷ LF’s condition was deemed stabilized 8 years after her diagnosis. In 2020 LF brought a lawsuit against Sanofi Pasteur, based on tort liability (fault liability - Article 1240 Code Civil), and strict product liability (Article 1245 Code Civil). The lawsuit was dismissed by the Court of Alençon and then by the Court of Appeal of Caen because LF’s claims were time-barred. Under the Code Civil, in the provisions implementing the PLD (Articles 1245-15 and 1245-16, implementing Articles 10 and 11 PLD) a claimant in a product liability case must bring a claim within three years from the date on which she was aware or ought to have been aware of the defect, the damage and the identity of the defendant. Further, in actions based on strict product liability there is a strict ten-year time limit (starting on the date when the product was placed on the market). The Cour de Cassation overturned the Court of Appeal’s decision and referred the case to the Court of Appeal of Rouen.  

⁸ As per Articles 10 and 11 of the current PLD, see below for analysis.

⁹ As per some previous judgments: Cass 1ère civ. 1 June 1999, B. 178; Cass. 2ème civ., 4 May 2000, no. 97-21.731; Cass 2ème civ. 11 July 2002, no. 01-02.182). The Cour de Cassation’s held that, in the event of an action for damages seeking compensation for bodily injury, the limitation period could only start running on the date when the damage has ‘stabilized’. Only then, according to the Court, the claimant would be able to assess the complete scope of her damage or injury.

¹⁰ Article 47 of the Charter provides for the right to an effective remedy: ‘Everyone whose rights and freedoms guaranteed by the Law of the Union are violated has the right to an effective remedy before a tribunal …’.

¹¹ See n. 3.

¹² C-338/24, AG Opinion, para. 43.

¹³ C-338/24, AG Opinion, para. 105.

¹⁴ C-338/24, AG Opinion, para. 124.

¹⁵ For instance, in Case C-52/00 Commission v. France, Judgment of 25 April 2002.

¹⁶ J.S. Borghetti, The development of product liability in France, in S. Whittaker (ed.) The development of product liability, Volume 1, Cambridge University Press, 2010, pp. 87-113., at p. 98.

¹⁷ Ibid. J.S. Borghetti, The development of product liability in France.

¹⁸ This approach was accepted by the ECJ as in line with the PLD in C-621/15 NW, LW, CW v. Sanofi Pasteur MSD SNC, judgment of 21 June 2017. Presumptions of defect and causation were also introduced in the new PLD: see Article 10.

¹⁹ H. Taschner, ‘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.

²⁰ Case C-183/00 Gonzalez Sanchez v. Medicina Asturiana SA, Judgment of 25 April 2002, para. 31.

²¹ Case C-52/00 Commission v. France, Judgment of 25 April 2002.

²² AG Opinion, para. 36. See note 2.

²³ As defined in Article 6 of the old PLD.

²⁴ C-338/24, AG Opinion, (para. 48).

²⁵ Articles 10 and 11 old PLD, Articles 16 and 17 new PLD.

²⁶ ECtHR in Sanofi Pasteur v France, 2020. In Howard Moor, the court held that, ‘where it is scientifically proven that a person is unable to know that they are suffering from a certain illness, such circumstances should be taken into account when calculating the limitation period or statute of limitations.’ Elimination of a long-stop is not merely a European idea: for instance some U.S. states’ supreme courts struck down as unconstitutional the periods of repose in all product liability cases or only in cases of personal injuries. See: “50-State Survey of Statutes of Limitations and Repose in Prescription Product Liability Cases”, JD Supra, 2020.

²⁷ LF – the claimant in the French case – has indeed, according to her doctors, stabilized.

²⁸ This case involved the general tort liability system.

²⁹ For instance – it would be more difficult to assess liability risks for the purpose of obtaining insurance.

³⁰ Case C-665/23 IL v. Veracash SAS, Judgment of 1 August 2025.