Elisabeth Schmitt had breast implants fitted. Unfortunately, they turned out to be defective. Contrary to quality standards, the French manufacturer had used industrial silicone. Schmitt had the implants removed. Meanwhile, the manufacturer had become insolvent. To obtain compensation for non-material and future material damage suffered, Schmitt filed a claim against TUV Rheinland LGA Products, acting as "supervisor" to the French manufacturer. TUV Rheinland was assigned by the French manufacturer to assess its quality system, as a so-called "notified body" in the sense of the European directive on medical devices (Directive 93/42/EEC). According to Schmitt, TUV Rheinland had been negligent in fulfilling its obligations as the notified body in the procedure relating to the EC declaration of conformity. TUV Rheinland had paid announced visits to the manufacturer, but it had never inspected business records or the implants. Had TUV Rheinland done so, Schmitt argued, it would have known that the French manufacturer had used improper silicone and Schmitt would not have suffered damage.
German questions on supervisory liability
In the proceedings brought by Schmitt before the German courts, the lower courts rejected her claim. The appeal court held that the activities of TUV Rheinland as a notified body were not meant to protect Schmitt as a patient, based on the so-called Schutznorm-doctrine. Under German law – like Dutch law for that matter – the violation of a legal rule does not automatically result in civil liability for damage caused. It does so only if and in so far as the violated rule aims to protect the harmed interest of the claimant. The appeal court also held that TUV Rheinland had sufficiently fulfilled its obligations under the directive, absent a suspicion that the French manufacturer used improper production methods. Schmitt appealed to the Bundesgerichtshof. The Bundesgerichtshof asked the European Court of Justice (ECJ) for guidance, submitting three preliminary questions on the interpretation of (national statutory provision implementing) the directive on medical devices.
Scope of investigative obligations by the notified body
In its judgment of 16 February 2017 (C-219/15), the ECJ first ruled on the scope of investigative obligations of the notified body. There is no "general obligation" for the notified body to perform unannounced inspections or examine devices or business records of the manufacturer. Yet the ECJ also considered that the notified body is under a "general obligation" to act "with all due diligence" and "under a duty to be alert". Once a notified body is confronted with evidence that a device may not comply with the requirements of the directive, it should respond. In the wording of the ECJ, "in the face of evidence indicating that a medical device may not comply" the notified body "must take all the steps" necessary to fulfil its obligations. The ECJ referred to a number of specific provisions, including the provision prescribing the notified body to suspend or withdraw an issued certificate.
Protective scope of the directive on medical devices
Secondly, the ECJ ruled on the protective scope of the directive on medical devices. The ECJ referred to its ruling in the case of Nordiska Dental (C-288/08) that the directive on medical devices aims to protect "health stricto senso" and the safety of third parties and other persons in general. In Schmitt, the ECJ curtailed this protective scope somewhat, considering that the "actual aim" of the directive is to protect "end users of medical devices". The harmed interest of Schmitt, in other words not having to suffer damage from defective breast implants, could be regarded as being within the protective scope of the directive. However, this is not to say that culpable negligence of TUV Rheinland necessarily results in civil liability towards Schmitt.
Civil liability as a matter for national law
Under EU law, there is another criterion. The ECJ set out that the directive should "confer" a "right" to compensation, referring to its decision in the case of Peter Paul (C-222/02), a case on member state liability for negligent supervision in the financial sector. However, this should not be assumed too quickly, especially "if the directive does not contain any express rule granting such rights". Apparently, in the view of the ECJ, the directive on medical devices does not contain such an express rule. "Similarly", the ECJ continued, "any mention" on the way the notified body may incur civil liability is absent in the directive. Therefore, the directive has to be interpreted as not conferring a right to compensation or governing conditions of possible civil liability. The "mere fact" there is reference in an annex to the directive that notified bodies are required to take out civil liability insurance did not convince the ECJ to reach a different view. The ECJ continued to note that EU law in general – including the directive concerning liability for defective products – does not exclude civil liability for culpable negligence of the notified body either. It is therefore up to national law to determine whether and under what conditions a notified body may incur civil liability towards end users, albeit subject to the principles of equivalence and effectiveness.
What can be concluded from the ruling of the ECJ in Elisabeth Schmitt? The directive does not provide her with a direct right to compensation. Yet civil liability of TUV Rheinland on the basis of national law is not excluded either. Beyond that, things are a little vague. The ECJ's considerations that the notified body should exercise "due diligence", be "alert" and act in "the face of evidence" that a device may not comply with the directive, suggest that the notified body should to some extent actively look out for such evidence. At the same time, the ECJ rules that there is no "general" obligation for the notified body to examine devices for example. The question is therefore what facts and circumstances would trigger a, so to speak, contextual obligation to do so. In the case of Elisabeth Schmitt, it is now up to the German courts to further decide her case. They will have to consider if TUV Rheinland has fulfilled its obligations, in view of this ruling of the ECJ, and if not, whether that results in civil liability under German law, including its Schutznorm-doctrine.