ECJ ruling on defective products

The ECJ has recently ruled on defective products in Boston Scientific Medizintechnik GmbH v AOK Sachesen-Anhalt. The Court has decided that when a group or production series of products has been shown to have a defect it is possible to classify all products within that group or production series as having a defect, without there being any need to show the particular product in issue has that defect.

Recently, the ECJ interpreted Article 6 of the Product Liability Directive, which concerns the safety a consumer is entitled to expect from a product. Its ruling concerned whether it was sufficient to prove that a device was potentially rather than actually defective.

Controversially, the ruling suggested that for any “products belonging to the same group or forming part of the same production series” as products that are defective, it is enough for a Claimant to prove a potential defect. However, it qualified this test as only applying to specific types of product. In Boston Scientific the test applied to medical products which “in the light of their function and the particularly vulnerable situation of patients using such devices, the safety requirements for those devices which such patients are entitled to expect are particularly high”. The products assessed here were pacemakers.

It appears that the test should only apply in the circumstances where there was an “abnormal potential for damage” and this must be assessed by taking into account “the intended purpose, the objective characteristics and properties of the product in question and the specific requirements of the group of users for whom the product is intended.”

The ECJ has made it explicitly clear that the new element of this ruling does not apply to all products, from every sector. Whether it applies to electrical components that are designed to prevent fires or limit the effect of electrical overloads remains to be seen, but manufacturers should be wary of Claimants trying to allege that it does.