The recent European Court of Justice (ECJ) decision in the case of Boston Scientific Medizentechnik GmbH v AOK Sachesen provides an interesting insight into the ECJ’s interpretation of a defective product within the meaning of the 1985 Product Liability Directive (the Directive).

The case, which started in the German courts, concerned two medical products: pacemakers, and implantable cardioverter defibrillators.

During the course of the main action, the German court requested a preliminary ruling from the ECJ as to the correct interpretation of Article 6 of the Directive. In particular, the German court sought clarification as to whether:

  • under the Directive, where an individual product is part of the same group or forms part of the same production series as other products found to have a potential defect, the individual product in question can be said to be defective without it being necessary to establish that it has such a defect
  • compensation for damage caused by personal injury includes the cost of the operation to remove and replace the defective product.

In answering “yes” to the first question, the ECJ made the following points:

  • in assessing whether a product is as safe as a person is entitled to expect, consideration must be given to the reasonable expectations of the public at large. The court held that this includes: “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 required”
  • some medical devices (such as those specific to the facts of this case) are used by a particularly vulnerable group of consumers. Given the function of such devices, consumers are entitled to expect particularly high safety requirements. In this case, the ECJ also noted that the potential defect arose out of the “abnormal potential for damage which those products might cause to the person concerned”.

On the second question, the ECJ held that:

  • compensation for damage relates to all that is necessary to eliminate harmful consequences and restore the level of safety which a person is entitled to expect
  • the producer is liable for the damage caused by a surgical operation for the replacement of a defective product where such an operation is necessary to correct the defect in the product in question.


The ECJ appears to have carved out a new type of “consumer” from the general population: those who are entitled to expect unusually high levels of safety. The decision appears to be limited to products (perhaps a special category of product) where the using public gains extra protection by virtue of a device’s specific features: high-risk function, vulnerable user profile, and an abnormally high potential for damage. Whether or not the ECJ’s decision will have any real impact on product liability claims in the UK remains to be seen. The decision is just the latest in a line of judgments considering the Directive and its manifestation in UK law, the Consumer Protection Act.