The background to this case is that a German plaintiff received breast implants in 2008. In 2010, it was discovered that a French manufacturer used industrial grade silicone in the implants and the plaintiff subsequently had the implants removed. As the French company was insolvent, the plaintiff brought proceedings against the German Notified Body for compensation. A Notified Body is the entity responsible for granting the CE mark to medical devices that is needed to place them on the market in the EU. In this case the German Notified Body had granted the CE mark to the French company for the breast implants.
It was argued by the plaintiff that the German Notified Body had not fulfilled its legal obligations. The plaintiff maintained that if business records had been reviewed and if the implants had been tested, the use of industrial grade silicone would have been discovered and prevented. The German District Court dismissed the plaintiff's claim and an appeal was also rejected by the Court of Appeal. The case then came before the German Federal Court of Justice, who referred a number of questions to the European Court of Justice. In essence, these questions concern whether Notified Bodies can be liable to individuals if they fail to fulfil their obligations.
The decision from the European Court of Justice may expand the scope of liability for Notified Bodies which will have wide-ranging consequences. This ruling is eagerly awaited to give clarity on the scope of responsibilities of Notified Bodies.
In similar proceedings in France, a French appeal court recently ruled that the German Notified Body was not liable to French plaintiffs; however, it is open to the European Court of Justice adopt a different stance.
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