CELEX: 62010CJ0495
Directive 85/374/EEC
Liability for defective products
Scope
National rules requiring public healthcare establishments to pay compensation, even when they are not at fault, for damage sustained by a patient as a result of the failure of equipment or products used in the course of treatment

This reference for a preliminary ruling concerns the 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 (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’).
The reference was made in the course of proceedings between (i) the Centre hospitalier universitaire (University Hospital),
Besançon (‘Besançon CHU’) and (ii) Mr Dutrueux and the Caisse primaire d’assurance maladie du Jura (primary sickness insurance
fund of the Department of the Jura) concerning compensation for burns caused to Mr Dutrueux by a heated mattress in the course
of an operation.

Legal context

Directive 85/374
The 1
st
, 4
th
, 13
th
, and 18
th
recitals in the preamble to Directive 85/374 state:
‘Whereas approximation of the laws of the Member States concerning the liability of the producer for damage caused by the
defectiveness of his products is necessary because the existing divergences may distort competition and affect the movement
of goods within the common market and entail a differing degree of protection of the consumer against damage caused by a defective
product to his health or property;
...
Whereas protection of the consumer requires that all producers involved in the production process should be made liable, in
so far as their finished product, component part or any raw material supplied by them was defective; whereas, for the same
reason, liability should extend to importers of products into the Community and to persons who present themselves as producers
by affixing their name, trade mark or other distinguishing feature or who supply a product the producer of which cannot be
identified;
…
Whereas under the legal systems of the Member States an injured party may have a claim for damages based on grounds of contractual
liability or on grounds of non-contractual liability other than that provided for in this Directive; in so far as these provisions
also serve to attain the objective of effective protection of consumers, they should remain unaffected by this Directive;
whereas, in so far as effective protection of consumers in the sector of pharmaceutical products is already also attained
in a Member State under a special liability system, claims based on this system should similarly remain possible;
...
Whereas the harmonisation resulting from this cannot be total at the present stage, but opens the way towards greater harmonisation;
…’
Article 1 of Directive 85/374 provides that ‘[t]he producer shall be liable for damage caused by a defect in his product’.
Article 3 of Directive 85/374 is worded as follows:
‘1. “Producer” means the manufacturer of a finished product, the producer of any raw material or the manufacturer of a component
part and any person who, by putting his name, trade mark or other distinguishing feature on the product presents himself as
its producer.
2.      Without prejudice to the liability of the producer, any person who imports into the Community a product for sale, hire, leasing
or any form of distribution in the course of his business shall be deemed to be a producer within the meaning of this Directive
and shall be responsible as a producer.
3.      Where the producer of the product cannot be identified, each supplier of the product shall be treated as its producer unless
he informs the injured person, within a reasonable time, of the identity of the producer or of the person who supplied him
with the product. The same shall apply, in the case of an imported product, if this product does not indicate the identity
of the importer referred to in paragraph 2, even if the name of the producer is indicated.’
Under Article 13 of Directive 85/374:
‘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.’
Directive 85/374 was notified to the Member States on 30 July 1985.

National legislation
Articles 1386-1 to 1386-18 of the French Civil Code transpose the provisions of Directive 85/374 into domestic law.
The referring court has explained that the liability of public healthcare establishments towards their patients is covered
by a special system of non-contractual liability based on the specific relationships which are formed between public hospitals
and the persons taken into their care. The system is governed both by legislative provisions and by principles developed by
the administrative courts.
Those principles include, in particular, the rule that a public hospital must pay compensation, even when it is not at fault,
for injury sustained by a patient by reason of the failure of equipment or products used in connection with the patient’s
treatment.

The dispute in the main proceedings and the questions referred for a preliminary ruling
Mr Dutrueux, who was 13 years old at the time, suffered burns during surgery carried out on 3 October 2000 at Besançon CHU:
the burns were caused by a defect in the temperature-control mechanism of a heated mattress on which he had been laid.
By a judgment of 27 March 2007, the Tribunal administratif de Besançon (Besançon Administrative Court) ordered Besançon CHU
to compensate Mr Dutrueux for the injury thus caused to him, requiring it to pay EUR 9 000 to him and EUR 5 974.99 to the
Caisse primaire d’assurance maladie du Jura.
An appeal brought against that judgment before the Cour administrative d’appel de Nancy (Nancy Administrative Court of Appeal)
by Besançon CHU was dismissed by a judgment of 26 February 2009 and Besançon CHU then appealed on a point of law to the Conseil
d’État (Council of State).
In support of that appeal, Besançon CHU maintained that the Cour administrative d’appel de Nancy had misinterpreted Directive
85/374, in particular Article 13 thereof, in holding that the directive did not prevent application of the principle deriving
from the case-law, whereby a public hospital is liable, even when it is not at fault, for damage caused to users as a result
of the failure of products or equipment used in connection with their treatment. Indeed, in Besançon CHU’s submission, it
follows from Directive 85/374, as transposed into French domestic law, that only the manufacturer of the mattress, once it
has – as in the present case – been duly identified, is to be held liable.
The Conseil d’État states that the principle concerned was established in its case-law by a decision of 9 July 2003, that
is to say, after Directive 85/374 had been notified to the Member States. However, since that decision was given in a dispute
which arose before the end of the period prescribed for transposition of Directive 85/374, the Conseil d’État considers that
it may be argued, having regard to Article 13 of the directive which preserves the ‘rights which an injured person may have
according to the rules of the law of contractual or non-contractual liability’, that that principle – which relates to a liability
system with a specific basis, distinct from that of the system of liability for defective products established by Directive
85/374 – remains applicable to the injury at issue in the main proceedings.
If that is not the case, the Conseil d’État takes the view that the outcome of the dispute before it will then depend on whether
the rules on liability laid down by Directive 85/374 apply to damage which the user of a defective product may have caused
to a third party in the course of providing a service for that third party’s benefit.
In those circumstances, the Conseil d’État decided to stay the proceedings and to refer the following questions to the Court
of Justice for a preliminary ruling:
‘1.      Having regard to the provisions of Article 13 thereof, does Directive [85/374] permit the implementation of a system of liability
based on the special situation of patients in public healthcare establishments, in so far as it recognises, inter alia, that
they have the right to obtain from such establishments, even when those establishments are not at fault, compensation for
damage caused by the failure of products and equipment which they use, without prejudice to the possibility for the establishment
to bring third-party proceedings against the producer?
2.      Does Directive [85/374] limit the ability of the Member States to define the liability of persons who use defective equipment
or products while providing services and, in so doing, cause damage to the recipient of those services?’

Consideration of the questions referred

The second question
By its second question, which it is appropriate to examine first, the referring court asks, in essence, whether the liability
of a service provider which, in the course of providing services such as treatment given in a hospital, uses defective equipment
or products and thereby causes damage to the recipient of the service falls within the scope of Directive 85/374, with the
result that the directive precludes the application of national rules, such as those at issue in the main proceedings, under
which such a provider is liable for damage thus caused, even in the absence of any fault on its part.
As is clear from the first recital in the preamble thereto, Directive 85/374 is intended to approximate the laws of the Member
States concerning the liability of the producer for damage caused by the defectiveness of his products.
It is settled case-law that 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 (Case C‑52/00
Commission
v
France
[2002] ECR I‑3827, paragraph 24; Case C‑154/00
Commission
v
Greece
[2002] ECR I‑3879, paragraph 20; and Case C‑402/03
Skov and Bilka
[2006] ECR I‑199, paragraph 23).
However, as is apparent from the 18
th
recital in the preamble thereto, Directive 85/374 does not seek exhaustively to harmonise the sphere of liability for defective
products beyond the matters regulated by it (Case C‑285/08
Moteurs Leroy Somer
[2009] ECR I‑4733, paragraphs 24 and 25).
The harmonised system of civil liability on the part of producers for damage caused by defective products, established by
Directive 85/374, is intended, as is clear from the first recital in the preamble thereto, to ensure undistorted competition
between economic operators, to facilitate the free movement of goods and to avoid differences in levels of consumer protection.
The limits set by the European Union  (‘EU’) legislature to the scope of the directive are the result of a complex balancing
of, inter alia, those different interests (see, to that effect,
Commission
v
France
, paragraphs 17 and 29, and
Commission
v
Greece
, paragraphs 13 and 29).
In that regard, the fourth recital to Directive 85/374 emphasises that consumer protection requires that all producers involved
in the production process should be made liable, in so far as their finished product, component part or any raw material supplied
by them was defective, and that, for the same reason, liability should extend to importers of products into the Community
and to persons who present themselves as producers by affixing their name, trade mark or other distinguishing feature or who
supply a product the producer of which cannot be identified.
Article 1 of Directive 85/374, which lays down the principle that ‘[t]he producer shall be liable for damage caused by a defect
in his product’, and Article 3 of the directive – which specifies, inter alia, the conditions in which the person who presents
himself as the producer of the product, the importer of the product into the EU or the supplier of the product must be deemed
also to be a ‘producer’ within the meaning of the directive – must be read in the light of the first and fourth recitals in
the preamble thereto.
With regard, more specifically, to the provisions of Article 3 of Directive 85/374, the Court has already had occasion to
state, following consideration of the
travaux préparatoires
culminating in the adoption of the directive, that it was after weighing up the parts played by the various economic operators
involved in the production and marketing chain that the choice was made to allocate liability for damage caused by defective
products in principle to producers, and only in certain defined cases to importers and suppliers, in the legal system established
by the directive (
Skov and Bilka
, paragraph 29).
The Court thus ruled out the possibility that Directive 85/374 brings about complete harmonisation only so far as the producer’s
liability for defective products is concerned, without, however, regulating the supplier’s liability. It held, in that respect,
that Articles 1 and 3 of the directive, which define the term ‘producer’, are not confined to regulating the liability of
the producer of a defective product, but determine which of the operators who have taken part in the production and marketing
processes will have to assume the liability established by the directive and that the class of persons liable against whom
an injured person is entitled to bring an action under the system of liability laid down by the directive is, in that regard,
defined exhaustively in Articles 1 and 3 of the directive (
Skov and Bilka
, paragraphs 24, 26, 30, 32 and 33).
In the present case, the liability that may be incurred by a user which, like Besançon CHU, employs, in the course of providing
treatment to a patient, a product or equipment that it has previously acquired, such as a heated mattress, is not among the
matters regulated by Directive 85/374 and hence does not fall within the directive’s scope.
Indeed, as the French and Greek Governments and the European Commission have maintained and as the Advocate General has also
stated at points 27 to 32 of his Opinion, such a user cannot be considered to be an operator in the production and marketing
chain of the product in question, to which, as the Court has just recalled, the definition of ‘producer’ in Article 3 of Directive
85/374 relates, nor, therefore, be treated as the supplier of the product within the meaning of Article 3(3) of the directive
– contrary to the contention of Besançon CHU. In particular, there is no ground for holding that, in the case before the referring
court, Besançon CHU supplied a patient with a product intended for use by the patient.
Moreover, the mere fact that there exists, alongside the system of producer liability established by Directive 85/374, a body
of national rules which provide for the no-fault liability of a service provider which has, in the course of providing hospital
treatment, caused damage to the recipient of the service because it has used a defective product does not undermine either
the effectiveness of that system of producer liability or the objectives pursued by the EU legislature by means of the system.
In that regard, it must be made clear, firstly, that when the law of a Member State provides for such liability on the part
of a service provider, that liability may, in any event and as has been stated in particular by the French, German and Greek
Governments and by the Advocate General at point 45 of his Opinion, be introduced only on condition that it does not adversely
affect the system established by Directive 85/374. Indeed, the application of national rules may not impair the effectiveness
of the directive (Case C‑203/99
Veedfald
[2001] ECR I‑3569, paragraph 27). Thus, it must remain possible for the producer’s liability to be put in issue when the
conditions laid down by the directive for such liability to exist are fulfilled. That possibility of putting the producer’s
liability in issue must be open not only to the injured person but also to the service provider who must thus be entitled
to use, to that end, a mechanism such as that of third-party proceedings, to which the national court refers in its first
question.
With regard, secondly, to the objectives pursued by the system of producer liability established by Directive 85/374, the
Court has already observed, at paragraphs 22 and 23 of this judgment, that the directive is intended, inter alia, to facilitate
the free movement of goods and to ensure undistorted competition between the economic operators concerned and consumer protection.
In that regard, it is appropriate, first of all, to note that nothing in the wording of Directive 85/374 gives grounds for
concluding that the EU legislature, in establishing producer liability for defective products, intended, so as to ensure undistorted
competition and to facilitate the free movement of goods, to deny the Member States the power, as regards compensation for
damage caused by a defective product used in the context of a service provision such as that at issue in the main proceedings,
to provide for a system of liability on the part of the service provider corresponding to that established by Directive 85/374
(see, by analogy,
Moteurs Leroy Somer
, paragraph 30).
Next, as the Greek Government has argued, while the free movement of goods depends, primarily, on the activities of producers,
importers and suppliers of those goods and while disparities between the national systems concerning the liability of those
operators are, therefore, clearly likely to have an impact on the free movement of goods, there are, in that regard, appreciable
differences so far as concerns the activity of service providers who, having acquired goods, use them in the provision of
services to third parties and, consequently, that activity cannot be equated with the activities of producers, importers and
suppliers.
Furthermore, given that any no-fault liability on the part of service providers under national law may be established – as
has been seen at paragraph 30 of this judgment – only on condition that it does not adversely affect the producer’s liability
as it is established by Directive 85/374, service-provider liability of that kind does not appear to be such as to distort
competition between operators in the production and marketing chain.
Finally, since any no-fault liability on the part of service providers is thus, at the very most, additional to producer liability
as deriving from Directive 85/374, it can, as the Advocate General has stated in points 45 and 46 of his Opinion, contribute
to enhancing consumer protection.
As to paragraphs 12 and 17 of
Veedfald
, to which reference has been made in the proceedings before the Court, the first question raised in the case giving rise
to that judgment concerned a situation in which ‘the producer of the defective product, in the course of providing a specific
medical service, produces and uses the product on a human organ’ and sought solely to ascertain whether or not, in such a
situation, the defective product could be regarded as having been put into circulation within the meaning of Article 7(a)
of Directive 85/374.
As the French Government has argued and as the Advocate General has also stated at point 38 of his Opinion, it follows that,
since the legal person whose liability was in issue was not only the provider of the service concerned, but also the ‘producer’
within the meaning of Directive 85/374, the question whether the directive might also cover the liability of a service provider
using defective products of which it is not the producer was not raised at all in
Veedfald
.
Accordingly,
Veedfald
cannot be construed as having ruled on that question. Nor, as the Advocate General has pointed out at points 39 and 40 of
his Opinion, did the Court rule on that question in its judgment in Case C‑183/00
González Sánchez
[2002] ECR I‑3901.
In view of all the foregoing, the answer to the second question is that the liability of a service provider which, in the
course of providing services such as treatment given in a hospital, uses defective equipment or products of which it is not
the producer within the meaning of Article 3 of Directive 85/374 and thereby causes damage to the recipient of the service
does not fall within the scope of that directive. Directive 85/374 does not therefore prevent a Member State from applying
rules, such as those at issue in the main proceedings, under which such a provider is liable for damage thus caused, even
in the absence of any fault on its part, provided, however, that the injured person and/or the service provider retain the
right to put in issue the producer’s liability on the basis of the directive when the conditions laid down by the latter are
fulfilled.

The first question
In view of the answer to the second question raised by the referring court, it is not necessary to consider the first question.

Costs
Since these proceedings are, for the parties to the main proceedings, a step in the action pending before the national court,
the decision on costs is a matter for that court. Costs incurred in submitting observations to the Court, other than the costs
of those parties, are not recoverable.
On those grounds, the Court (Grand Chamber) hereby rules:
The liability of a service provider which, in the course of providing services such as treatment given in a hospital, uses
defective equipment or products of which it is not the producer within the meaning of Article 3 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, as amended by Directive 1999/34/EC of the European Parliament and of the Council of 10 May
1999, and thereby causes damage to the recipient of the service does not fall within the scope of the directive. Directive
85/374 does not therefore prevent a Member State from applying rules, such as those at issue in the main proceedings, under
which such a provider is liable for damage thus caused, even in the absence of any fault on its part, provided, however, that
the injured person and/or the service provider retain the right to put in issue the producer’s liability on the basis of the
directive when the conditions laid down by the latter are fulfilled.
[Signatures]
*
Language of the case: French.