In this case submitted to the CJEU by the German Federal Court, a German company, which sells pacemakers imported from the USA, discovered that these products could be potentially defective and might create a danger for patient safety. The company offered to supply new pacemakers, free of charge, to replace the ones previously installed. The German company then faced claims for reimbursement of the costs of the replacement. These claims are based on the German Law implementing Council Directive 85/374/EEC of 25 July 1985 concerning liability for defective products, which provides that the producer of a device (or any person who imports into the Community a product for sale) shall be liable for damage caused by this product where such product does not provide the safety which a person is entitled to expect.

The CJEU was asked to decide whether all the pacemakers from the same batch of production should be considered as defective even though the defect remained simply a potential one, since not all the pacemakers had been checked.

The Court answered in the affirmative. Given the nature of the devices and the abnormal potential for damage of these products, the Court decided that “where it is found that products belonging to the same group or forming part of the same production series (...) have a potential defect, such a product may be classified as defective without there being any need to establish that that product has such a defect”.

The CJEU also rules that the damage caused by a surgical operation for the replacement of a defective product “constitutes ‘damage caused by death or personal injuries’ for which the producer is liable [pursuant to article 9 of the Directive], if such an operation is necessary to overcome the defect in the product in question”.