On 5 March 2015, the European Court of Justice (CJEU), ruled in favour of greater patient protection and compensation after a question of product liability was referred to them by a German court.

The facts relate to faulty implantable pacemaker and cardioverter devices. The German court had asked two questions of law of the CJEU on preliminary ruling, both relating to the Product Liability Directive 85/374 (the Directive). These questions were whether:

  1. Article 6(1) of the Directive (which concerns whether a product is defective) should be interpreted to mean in the case of sensitive implanted devices, whether all products of the same group should be labelled as defective, purely on the basis that there is a substantial increase in their likelihood of failure following new evidence; and
  2. whether a finding that this class of product is uniformly defective under the Directive would mean that product manufacturers must bear the cost of removing the device in an operation and implanting a new one? (Manufacturers would bear this liability as under Article 9(a) of the Directive, the removal of the device would be classed as damage caused by personal injury).

The CJEU answered both questions in the affirmative but stated that the answer would depend on the specific product on a case by case basis. What seems of greatest importance in the current case was the standard of safety expected of such devices and their capability to do damage if they were faulty.

The case means that for these type of ultra-sensitive implanted medical products that could cause serious harm, consumers, insurers and other interested bodies need merely to show an increased risk of harm from one faulty product to apply it across a class, leading the device producer to recall all products and foot the bill for their replacement in each patient.

It remains to be seen whether this case will open the floodgates to increased costs of replacement and product withdrawals in the industry. The Court’s careful approach to say that interpretation of the Directive would depend on the fault and the nature of the medical device in question, including the necessity for an operation in the current case, may limit this case as a relatively rare example at one end of a spectrum.

See judgement: Boston Scientific Medizintechnik GmbH v AOK Sachsen-Anhalt — Die Gesundheitskasse (C 503/13)