Compensation claims for personal injury in cases of progressive diseases

From what point may a patient suffering from a progressive disease bring a claim for compensation for personal injury caused by vaccination with a defective vaccine? Is the expiry of the ten-year limitation period, regardless of whether the claimant’s medical condition has stabilised, compatible with the right of access to a court? And may an injured party rely on general fault-based liability in addition to liability for a defective product? These questions were addressed by the Court of Justice of the European Union in its recent judgment in Sanofi Pasteur[1], the conclusions of which may have significant implications for judicial practice in disputes concerning liability for damage caused by defective products throughout the European Union.

Liability for defective products under Directive 85/374/EEC

Before turning to the judgment itself, it is useful to briefly outline the legislative framework to which the CJEU's decision relates. Directive 85/374/EEC[2] harmonises the rules governing the liability of producers and certain other entities for damage caused by defective products throughout the European Union.

The cornerstone of this harmonised regime is the principle of strict liability of the producer. The injured person is not required to prove fault; it is sufficient to establish the defect in the product, the damage suffered, and the causal relationship between the two. A producer may be exonerated from liability only in limited circumstances, for example by proving that the defect did not exist when the product was put into circulation or that the state of scientific and technical knowledge at the relevant time was not such as to enable the existence of the defect to be discovered.[3]

This strict liability regime is balanced by a ten-year long-stop limitation period, running from the date on which the defective product was put into circulation. In addition, the injured person must bring the claim within a three-year limitation period, which begins to run from the date on which the claimant became aware, or should reasonably have become aware, of the damage, the defect and the identity of the producer.[4]

Background of the case

The injured party, a French patient, received a vaccine against diphtheria, tetanus and poliomyelitis in 2003. She subsequently developed health complications which resulted in repeated periods of incapacity for work. According to an expert report, her medical condition did not stabilise until 2016. However, she did not bring her claim against the vaccine manufacturer – both under the regime of liability for defective products and under the general rules of fault-based liability – until 2020. After the lower courts found the claimant's action to be time-barred, the matter was referred to the Court of Justice of the European Union by the French Court of Cassation.

A key aspect of the case was the fact that the claimant suffered from a progressive disease, that is, a condition that gradually worsens over time and, in the absence of effective treatment, leads to a continuing deterioration of the patient's health. 

Concurrent liability for defective products and fault-based liability

Above all, the CJEU confirmed that a producer's fault-based conduct constitutes a basis of liability distinct from a product defect within the meaning of Directive 85/374/EEC.[5] Consequently, an injured party may seek compensation not only under the regime of liability for defective products but also on the basis of fault-based liability. This may be the case, for example, where the producer continued to place a product on the market despite being aware of its defect, or failed to exercise the required standard of care in light of known risks. This conclusion is particularly significant because claims based on fault-based liability are not subject to the ten-year long-stop limitation period applicable under the Directive and may therefore provide an alternative avenue for obtaining compensation.

The three-year limitation period and the concept of ‘damage definitively becoming apparent’

The key issue before the CJEU was determining the starting point of the three-year limitation period under Article 10 of Directive 85/374/EEC. According to the Court, the limitation period begins to run on the date when the claimant became aware, or should reasonably have become aware, of the damage that has definitively become apparent in connection with the defective product, as well as of the defect and the identity of the producer, regardless of any subsequent development of the disease. The Court referred to this point in time as ‘the damage definitively becoming apparent’.[6] 

The judgment therefore rejects the approach previously adopted, among others, by Czech courts, under which the injured person‘s medical condition is assessed as a whole and the limitation period begins to run only once the condition has stabilised, i.e. upon the completion of continuous treatment.[7] The CJEU justified its conclusion by noting that, in cases involving progressive diseases, the date on which the damage stabilises is inherently uncertain and may, in some instances, coincide with the date of the claimant's death. Such an interpretation would, in the Court's view, undermine legal certainty for producers and compromise the effectiveness of the protection established by the Directive, as the damage might not stabilise until after the expiry of the ten-year long-stop limitation period.

At the same time, the CJEU has emphasised that the Directive does not prevent Member States from introducing mechanisms enabling injured parties to seek additional compensation where their condition subsequently deteriorates. However, Directive 85/374/EEC itself does not confer such a right.

Validity of the ten-year long-stop limitation period

The CJEU also examined whether the application of the ten-year limitation period under Article 11 of Directive 85/374/EEC in cases involving patients suffering from progressive diseases is compatible with the right of access to a court guaranteed by the Charter of Fundamental Rights of the European Union. It should be noted that the European Court of Human Rights has previously found such incompatibility in cases involving latent diseases, i.e. diseases where the injured person becomes aware of the damage to their health only after a delay due to an initially asymptomatic course of the illness.[8]

Nevertheless, the CJEU once again favoured the protection of legal certainty for producers, reflected in the temporal limitation of their liability, and rejected an interpretation that would grant patients suffering from progressive diseases a more favourable position than that afforded under the general limitation regime. The Court emphasised that, unlike a person suffering from a latent disease, an injured party affected by a progressive disease is in a position where the damage may become definitively apparent within the ten-year period and is therefore not deprived of effective access to a court.[9]

The judgment further clarifies that the Directive mandatorily fixes the commencement of the ten-year period at the date on which the product is put into circulation and recognises only one ground for interrupting that period: the institution of judicial proceedings. Precisely because the three-year limitation period begins to run from the moment the damage becomes definitively apparent (rather than from the stabilisation of the claimant's medical condition), an injured party suffering from a progressive disease is ensured a genuine opportunity to bring proceedings within the ten-year period.[10]

The Advocate General's approach

It is also worth noting that the Advocate General proposed a different approach in the present case, one that was more favourable to injured parties. Specifically, she advocated declaring the ten-year long-stop limitation period invalid and linking the commencement of the limitation period to the date on which the claimant's medical condition stabilised. In her view, persons suffering from progressive diseases are unable to quantify the full extent of the damage suffered and are therefore deprived of their right to effective access to a court.[11] The CJEU, however, did not endorse this line of reasoning.

Conclusion

The CJEU's judgment in Sanofi Pasteur establishes three key principles: (i) the harmonised regime governing liability for defective products does not preclude the concurrent application of fault-based liability claims; (ii) the three-year limitation period begins to run from the date on which the damage definitively becomes apparent, rather than from the date on which the claimant's medical condition stabilises in the strict sense; and (iii) the ten-year long-stop limitation period remains valid even in cases involving progressive diseases.

The CJEU's findings therefore strengthen legal certainty for producers by confirming a clear temporal limit on their liability. At the same time, the Court leaves it to the Member States to establish rules enabling injured parties to obtain full compensation for the damage suffered, including, where appropriate, additional compensation in the event of a further progression of the disease.