Opinion of the CJEU Advocate-General in Case C-581/18 RB v TÜV Rheinland LGA Products GmbH,
Background
The effects of the Poly Implant Prothčse SA ('PIP') defective breast implant scandal continue to be felt almost ten years since it first came to light that PIP had fraudulently used cheaper, industrial grade silicone in the implants that it manufactured. Due to PIP's insolvency, those affected have attempted to obtain compensation from other sources, including the relevant notified body, TÜV Rheinland1, on the basis that this body had negligently certified PIP's products and the French regulatory authorities.
Case against PIP's insurer
The Opinion of Advocate-
The German court referred the case to the CJEU, asking whether the territorial limitation in the
Within the scope of EU law
Advocate-
Regulatory diversity
Advocate-
However he rejects the suggestion that Article 18 TFEU should operate as a free-standing, substantive obligation, stating that this would extend beyond anything that the free movement case-law ever contemplated. He comments that, interpreted in that way, there would be no limit to the scope of Article 18 TFEU noting that "[i]n today's interconnected world, sooner or later, there is inevitably some sort of interaction with goods, services or persons from other Member States" and "[i]f that were enough to trigger the independent applicability of Article 18 TFEU, every single rule in a Member State would be caught by that provision". The fact that goods once came from another Member State is not a sufficient reason to suggest that any matter later concerning those goods is covered by EU law. Furthermore, the insurance arrangements in issue do not limit the freedom of companies such as
No obligation to insure
The Opinion notes that EU law has not harmonised the issue of insurance against civil liability for the use of medical devices. The current regulatory framework for medical devices under Directive 93/42, requires notified bodies to take out civil liability insurance, but is silent as to manufacturers. Article 10(16) of the new Medical Devices Regulation (EU) 2017/745 only requires manufacturers "to have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law". The Advocate-General notes that this could "perhaps be interpreted, at a stretch, as potentially also including insurance against civil liability." However, he concludes that it is clear that the legislation was not intended to provide one harmonised solution, such as compulsory insurance for medical device manufacturers. This contrasts with the position with, e.g. motor insurance.
No discrimination
The Advocate-General finds that, in the absence of harmonisation, there is nothing to prevent Member States from taking steps at national level, as
The fact that PIP's insurance cover with
Ultimately, however, the Opinion recognises that to construe Article 18 TFEU in this way would make it a "limitlessly harmonising provision" that would upset the division of competences between the EU and Member States and create problematic conflicts between legal regimes within the internal market.
Comment
The Opinion is consistent with the position that insurance is not intended to be compulsory under Article 10(16) of the Medical Devices Regulation (EU) 2017/745. Given the highlighted risks of straying too aggressively into the competence of national legal systems, it seems likely that the Advocate-General's Opinion will be followed in substance in the CJEU's judgment. A finding to the contrary would be potentially far-reaching and could e.g. significantly interfere with insurers' rights under contracts of insurance which they had negotiated and concluded on the basis of a territorially limited exposure to liability.
Footnotes
1 Case C-219/15
2RB's claim was also brought against the implanting doctor and TÜV Rheinland LGA Products GmbH, however the questions posed by the German Court to the CJEU concerned only the potential liability of
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