Medical devices: Liability for potential defects

Where a medical device has a potential defect, all products of the same model may be classified as defective.

The manufacturer of such a defective device must reimburse the costs relating to the replacement of the product where such replacement is necessary and to restore the level of safety, which a person is entitled to expect.

The Product Liability Directive 85/374/EEC provides that the producer is liable for damage caused by a defect in his product.

A company which sold pacemakers in Germany found, after carrying out quality control checks, that those products might be defective and constitute a danger to patient health. In view of that situation, the producer recommended physicians to replace the pacemakers implanted in patients with other pacemakers provided free of charge.

Health insurers claim reimbursement of the costs relating to the replacement from the manufacturer.

In yesterday’s judgment on C-503/13 and C-504/13, the Court found that medical devices are subject to particularly high safety requirements. The Court observed in that regard that the potential lack of safety of such products, which would give rise to liability on the part of the producer, stems from the abnormal potential for damage, which they might cause to the person concerned.

Accordingly, the Court found that where it is found that 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 found that the costs relating to such replacement constitute damage for which the producer is liable.