ECJ ruling
Implications for national law


In October 2000 the plaintiff, who was 13 years old at the time, suffered burns during surgery carried out at the Besancon University Hospital Centre (CHU), a public hospital. The injury resulted from a defect in the temperature control mechanism of a heated mattress used during the surgery. The plaintiff sued the CHU before the Besancon Administrative Court, which on March 27 2007 ordered the CHU to compensate the plaintiff.

The CHU appealed before the Nancy Administrative Court of Appeal, which confirmed the first judgment in a February 26 2009 decision.

The CHU challenged this decision on a point of law before the Council of State. The CHU argued that the case law principle that a public hospital is liable, even in the absence of fault, for damages caused to patients as a result of the failure of products or equipment used in connection with their treatment could not apply, since according to the EU Product Liability Directive (85/374/EC), only the manufacturer of the mattress, once identified, should be held liable.

The Council of State decided to stay the proceedings and referred to the European Court of Justice (ECJ) for a preliminary ruling. The issue presented to the ECJ was 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 the directive.

ECJ ruling

Based on Recital 18 of the Preamble to the directive, the ECJ first considered that although the directive is intended to approximate the laws of member states concerning liability for defective products, it does not seek to harmonise exhaustively the sphere of liability for defective products beyond the matters regulated by it, as previously held in Moteurs Leroy Somer.(1)

Referring to Skov and Bilka,(2) the court held that the aim of the directive is not only to regulate the liability of the producer of a defective product, but also to determine which of the operators which have taken part in the production and marketing processes must assume liability under the directive.

The court also held that the class of person that may be held liable is defined exhaustively in Articles 1 and 3 of the directive – namely, the producer and, in certain cases, the importers and suppliers.

This reasoning led the court to conclude that in the case at hand, the liability that may be incurred by a user (which is not a producer, importer or supplier) that employs, in the course of providing treatment to a patient, a product or equipment that it has previously acquired is outside the scope of the directive.

Later in the decision the court also held that the French principle according to which a service provider is liable even in the absence of fault may be established provided that it does not adversely affect the producer's liability as established by the directive. The court found that it did not appear to be a principle such as to distort competition between operators in the production and marketing chain.

Implications for national law

As a result of the ECJ's decision,(3) the directive does not hinder a member state from implementing a specific liability scheme for public hospitals, provided that such scheme does not prevent seeking a manufacturer's liability under the directive should the conditions for such liability be fulfilled.

Under French law, the liability of health professionals is regulated by Article L1142-1 of the Code of Public Health, which provides that:

"Except for cases in which they may be held liable as a result of a defective healthcare product, health professionals listed in part four of this code, as well as any establishment, service, or body in which individuals acts of prevention, diagnosis, or health care are performed, will be liable for the damages resulting from these acts only in case of fault."

When it was first enacted in 1998, the act transposing the directive into French law provided that the professional supplier of a defective good should be held liable under the same conditions as the manufacturer of the defective good, thus departing from the directive.

In 2002, when Article L1142-1 was enacted, it was interpreted as meaning that healthcare professionals could be held liable as suppliers of defective products.

The ECJ's decision puts an end to the previous interpretation of the text. Healthcare professionals can no longer be held liable as suppliers under the directive.

However, under French administrative case law, public hospital remain liable towards their patients in case of use of a defective product.

This ECJ's decision is likely to be profitable for plaintiffs, although in turn hospitals – to the extent that the conditions imposed by the directive are met – will be able to make recovery claims against the manufacturers of defective products.

For further information on this topic please contact Carole Sportes at BOPS (SCP Bouckaert Ormen Passemard Sportes) by telephone (+33 1 70 37 39 00), fax (+33 1 70 37 39 01) or email ([email protected]).


(1) Case C-285/08 Moteurs Leroy Somer [2009], ECR I-4733.

(2) Case C-402/03 Skov and Bilka [2006] ECR I-199, paragraph 29.

(3) December 21 2011.