Advocate General’s Opinion on implantable medical devices: product faults due to increased risk of failure
On 21 October, Advocate General Yves Bot commented on the question of the defectiveness of implantable medical devices due to an increased probability of failure – and affirmed this (Opinion in the Joined Cases C-513/13 and C-504/13).
These cases concern disputes between German health insurance companies and the German sales company of a US American manufacturer of pacemakers and defibrillators. The proceedings before the ECJ are in this respect based on requests for preliminary rulings filed by the German Federal Court of Justice (Bundesgerichtshof). The proceedings were triggered by the safety instructions issued by the US company after carrying out internal quality controls that certain defective components in pacemakers and defibrillators can possibly lead to the failure of the devices. The probability of failure in the case of the pacemakers was said to be 17 to 20 times higher than was normally the case; a considerable number of defects were established with respect to the defibrillator. Several implanted devices were therefore replaced, following which the health insurance companies demanded reimbursement of the costs of the revision surgery.
Legal background and questions submitted by the German Federal Court of Justice for preliminary rulings
These proceedings are based on the Product Liability Directive 85/374/EEC and its transposition in the German Product Liability Act (Produkthaftungsgesetz – ProdHaftG).
With respect to Article 6 of the Directive and Sec. 1 of the German Product Liability Act, the German Federal Court of Justice submitted the question to the ECJ for a preliminary ruling of whether a product is already defective as defined by these regulations if pacemakers in the same product group have a significantly increased risk of failure or a malfunction has occurred in a significant number of devices in the same series of defibrillators (but a defect has not been detected in the device which has been implanted in the specific case in point).
The German Federal Court of Justice also requested a preliminary ruling on the question of whether the costs of the operation to remove the device and implant a new device constitute damage caused by personal injury as defined by Article 9 of Directive 85/374/EEC and Sec. 8 of the German Product Liability Act.
Opinion of the Advocate General
The Advocate General answered the first question submitted for a preliminary ruling in the affirmative: he stated that the decisive factor was that product liability in accordance with the Directive did not first apply in the case of a specific defect, but that the defectiveness is already to be affirmed if a product cannot provide the safety which can legitimately be expected on the part of patients. In the Advocate General’s opinion, this interpretation was also required by consumer protection considerations – it was specifically not necessary to wait and see whether the increased risk of failure actually occurs. According to the Advocate General, the type of product was still decisive here because the product concerned is one which is implanted in the human body and is vital for the patient, for which an increased risk of failure cannot be accepted. He concluded that this specific safety risk created a disproportionate danger for patients and has to be taken into consideration accordingly when assessing defectiveness.
The second question submitted for a preliminary ruling was also ultimately answered in the affirmative: the Advocate General stated that a broad interpretation of the term “personal injury” was to be assumed as well as the fact that in view of the defective product, the manufacturer could not avoid liability with a general reference to the fact that the replacement of the device was ultimately carried out on the initiative of the patient. The Advocate General did, however, point out that there must always be a causal link between the defect resulting from the risk of failure and the damage resulting from preventative surgery to replace the device. He also stated that in the specific individual case alternatives could also exist which provide the same level of safety but cause less damage and therefore break the causal link. It should, however, in the Advocate General’s opinion be left to the national courts to review this.
The Advocate General’s comments on the first question submitted for a preliminary ruling in particular mean increased liability risks for manufacturers of implantable devices. This is because with respect to the safety risk associated with the failure of implantable medical devices, the Advocate General applies a much stricter standard of liability compared to other products. It remains to be seen to what extent the ECJ will follow the notable comments made by the Advocate General. The Advocate General’s Opinion is, however, often indicative – the decision of the ECJ is expected toward the end of the year.
Amid all the substantiated criticism of the case law of the lower courts relating to suspected defects, on which the requests for preliminary rulings of the German Federal Court of Justice are based, the medical devices industry will if necessary have to prepare itself for a stricter liability environment based on European law after carrying out product safety measures.