Where a medical device has a potential defect, all products of the same model may be classified as defective, the European Court of Justice recently asserted. There is no need for proof that each and every product is, in actual fact, defective.

The EU’s Product Liability Directive provides that a producer or an importer of a product is always liable for damage caused by a defect in a product he places on the market. In all such cases, the injured consumer must prove the actual damage incurred, the defect in the product and the causal relationship between damage and defect. However, there is no need to prove negligence or fault on the part of the producer or importer.

The facts of this particular case which came before the Court of Justice of the European Union (CJEU) were briefly as follows. A company which sold pacemakers in Germany found, after carrying out quality control checks, that these products might be defective and constitute a danger to patient health. The manufacturer, therefore, recommended that physicians should replace the implanted pacemakers with other pacemakers which were provided free of charge by the manufacturer.

The insurers of individuals who had their pacemaker replaced filed proceedings against the manufacturer before the German courts, requesting reimbursement of the costs relating to the replacement of the device.

In the course of these proceedings, the German Federal Court made a preliminary reference to the CJEU, requesting the latter court for guidance as to whether, in terms of EU law, it is permissible to consider all the devices which were replaced as defective, even though no defect was specifically detected in the replaced devices but such defect emerged solely in the course of quality control checks carried out by the manufacturer on devices of the same model. The national court also requested the European Court to ascertain whether the cost of replacing the products could be considered in terms of EU law as damage for which the producer is liable.

The CJEU observed that, in view of their function and the vulnerability of patients using them, the medical devices in question are subject to particularly high safety requirements. This is necessarily so since any defect therein could cause abnormal damage to the person concerned. The Court concluded that where a medical device has a potential defect, it is possible to classify as defective all products of the same model, without there being any need to show that the product is defective in each individual case. The court also ruled that the costs relating to the replacement of the pacemakers did constitute damage for which the producer is liable under the product liability directive.

The welfare of each and every European citizen is at the very heart of the EU’s consumer acquis. The various consumer laws enacted together with the wealth of jurisprudence related to this policy which has evolved along the years serve to ensure the protection of the health, safety as well as the economic interests of all European consumers.

mariosa@vellacardona.com

Mariosa Vella Cardona is a freelance legal consultant specialising in European law, competition law, consumer law and intellectual property law.