On March 5th 2015 the Court of Justice of the European Union published its Decision in In Joined Cases C‑503/13 and C‑504/13, concerning pacemakers and Implantable Cardioverter Defibrillators.
The abovementioned judgement introduced a concept that can be defined as “Product Batch Liability” for Active Implantable Medical Devices and high-risk medical devices under Article 6 of Directive 85/374/EEC , stipulating that: “… a product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account”
This concept is likely to have huge consequences for the manufacturers of medical devices circulating in the European Union in terms of post-market surveillance and risk management procedures.
The newly- introduced concept of ‘Product Batch Liability’
In its recent Decision, the European Court recognised that – in cases of high risk medical devices – a product can be considered defective simply because it is included in the same batch as a defective product, regardless of whether any actual defect was detected in each product and provided that the manufacturer recommended the products’ recall as a corrective action.
Joined Cases C‑503/13 and C‑504/13: the referred questions
The European Court Decision followed a referral for a preliminary ruling introduced by the German Federal Court and concerning the scope of Article 6 of the Product Liability Directive 85/374/EEC and in particular the following aspects:
•Whether Article 6(1) of Directive 85/374 is to be interpreted as meaning that, where it is found that products belonging to the same group or forming part of the same production series, such as pacemakers or implantable cardioverter defibrillators, have a potential defect, it is possible to classify each product of the series as defective, without there being any need to establish that the product in question actually has such a defect.
•Whether Article 1 and section (a) of the first paragraph of Article 9 of Directive 85/374 are to be interpreted as meaning that the damage caused by a surgical operation for the replacement of a defective product, such as a pacemaker or an implantable cardioverter defibrillator, constitutes ‘damage caused by death or by personal injuries’ for which the producer is liable. Hence, whether the producer should cover the costs of the replacement operations.
Conclusions of the European Court of Justice
The Court gave a positive answer to both questions, meaning that:
•All the products belonging to the series might be considered as defective;
•The manufacturer can be held liable for the costs related to the replacement of the recalled (defective) devices.
However, the Court specified that the notion of safety should be assessed by taking into account all the relevant circumstances such as 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.
With specific regard to medical devices such as the pacemakers and implantable cardioverter defibrillators, the Court made clear that – in such cases – the manufacturer’s liability should rely on their specific function and on the particularly vulnerable situation of patients using such devices that make the safety requirements for those devices particularly high.
Potential Implications of the Court Decision
The potential implications of the ‘Product Batch Liability’ for manufacturers of medical devices are not clear yet. However the latter might have a significant impact with regard to all the procedures related to post-market surveillance, risk assessment & risk management and CAPA.
Obelis European Authorized Representative Centre can support manufacturers in building up a solid strategy providing a wide range of CE advisory services related to product safety and post-market surveillance.
If you would like to know more on product safety and post-market surveillance, contact us.