Life Sciences Horizons Brochure 2025 - Flipbook - Page 67
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2025 Horizons Life Sciences and Health Care
Product liability directive burden of proof lowered
The main objective of the PL Directive is to guarantee
the right to compensation in an effective and
harmonized way. To this end, significant changes
have been made to reduce the burden of proof on
claimants by establishing specific presumptions
as set out in recital 46. Article 10 deals with these
presumptions in two aspects: defect and causal link.
A defect is presumed to exist where:
the defendant fails to comply with the obligation to disclose
documentation under Article 9;
the product does not comply with the mandatory safety
requirements laid down in national or EU legislation, such
as Regulation (EU) 2023/988; and
the damage occurs as a result of a malfunction during the
normal or foreseeable use of the product. In addition, a causal
link is presumed where, once it is established that a product
is defective, the nature of the damage is consistent with
that defect.
Article 10 is particularly worrying because it provides that, even if
the defendant has provided information on the product, the
defect must be presumed if it remains excessively difficult to
prove the defect or the causal link, or if it is “probable,” at the
discretion of the national court, that the product is defective.
Recital 48 justifies this measure as a way of prioritizing the right to
compensation in view of the technical or scientific difficulty of
proving the defect or the causal link.
This measure raises a legal debate as to when it is considered
“excessively difficult” to prove the defect and the causal link, even
if the defendant has disclosed information proving the absence of
the defect or the causal link. The harmonization intended by the
Directive is not complete, as such important presumptions
depend on national law, and their application varies from one
Member State to another.
For example, the Spanish Supreme Court ruled on 1 March that a
product was defective because it did not offer the expected level of
safety, on the basis of a health warning issued by the manufacturer,
the voluntary withdrawal of the product and tests carried out in
accordance with the manufacturer's recommendations. The
Supreme Court held that the "concept of expected safety" was not
satisfied, and thus assimilated product liability to strict liability.
Similarly, the European Court of Justice (ECJ) ruled in its
judgment of 5 March 2015 (Joined Cases C-503/13 and C-504/13).
Moreover, this presumption may render Article 9 meaningless, as
the national authority will have to presume the damage, despite
the defendant disclosing the requested information, if the product
is technically or scientifically complex.
Given the increasing technical complexity of the products covered
by the PL Directive, this presumption allows claimants to obtain
compensation with a lower burden of proof, effectively reversing
the burden of proof on the defendant. This creates legal
uncertainty for responsible economic operators (Article 8), as it
will depend on the discretion of each court, tilting the balance in
favor of the plaintiff and reinforcing strict liability.
Margarita Morales
Counsel
Madrid
Paloma Martínez
Associate
Madrid
