Opinion of the Advocate General — ECLI:EU:C:2020:77
Date: 2020-02-06
Language of the case: German
Subject matter: Consumer protection;Approximation of laws;Public health;Anti-discrimination;Non-discrimination on grounds of nationality
Procedure: Reference for a preliminary ruling;Reference for a preliminary ruling - decision unnecessary
Origin: Germany

Summary C-581/18 - 1 
Case C-581/18 
Summary of the request for a preliminary ruling pursuant to Article 98(1) of 
the Rules of Procedure of the Court of Justice 
Date lodged: 
19 September 2018 
Referring court: 
Oberlandesgericht Frankfurt am Main (Higher Regional Court of 
Frankfurt am Main, Germany) 
Date of the decision to refer: 
11 September 2018 
Applicant and appellant: 
RB 
Defendants and respondents: 
TÜV Rheinland LGA Products GmbH 
Allianz IARD S.A. 
      
Subject matter of the main proceedings 
Action for damages against the French insurer of a breast implant manufacturer 
based in France – Limitation of liability to cases of damage occurring in France 
and in French overseas territories – Possible third-party effect of Article 18 TFEU 
Subject matter and legal basis of the reference 
Interpretation of EU law, Article 267 TFEU 
Questions referred 
1. Is the prohibition of discrimination under Article 18(1) TFEU directed not 
only at the EU Member States and the Union institutions, but also at private 
parties (direct third-party effect of Article 18(1) TFEU)? 
EN 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING - CASE C-581/18 
 
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2. If the first question should be answered in the negative and Article 18(1) 
TFEU is not applicable to relations between private parties: Is Article 18(1) 
TFEU to be interpreted as meaning that this provision precludes restricting 
cover to cases of damage occurring in metropolitan France and the French 
overseas territories because the competent French authority, the Bureau 
central de tarification (central pricing office), did not object to the 
corresponding clause, even though that clause is contrary to Article 18(1) 
TFEU because it involves indirect discrimination on the basis of nationality? 
3. If the first question should be answered in the affirmative: Under what 
conditions can indirect discrimination be justified in cases of third-party 
effect? In particular: Can territorial restriction of insurance cover to cases of 
damage occurring within a certain EU Member State be justified with the 
argument of restriction of the liability obligation of the insurance company 
and the premium level if the relevant insurance policies at the same time 
provide that, in the event of serial damages, the cover per case of damage 
and the cover per insurance year are limited in terms of amount? 
4. If the first question is to be answered in the affirmative: Is Article 18(1) 
TFEU to be interpreted as meaning that if, contrary to Article 18(1) TFEU, 
the insurer has only settled claims in cases of damage occurring in 
metropolitan France and the French overseas territories, it is prohibited from 
objecting that payment could not take place because the maximum cover 
amount was already reached, if the case of damage occurred outside of those 
territories? 
Provisions of EU law cited 
Article 18(1) TFEU 
Council Directive 93/42/EEC of 14 June 1993 concerning medical devices 
(OJ 1993, L 169, p. 1) 
Commission Directive 2003/12/EC of 3 February 2003 on the reclassification of 
breast implants in the framework of Directive 93/42/EEC concerning medical 
devices (OJ 2003, L 28, p. 43)  
Provisions of national legislation cited 
Article L.1142-2 Code de la santé publique (public health code) 
Article 124-4(3) Code des assurances (insurance code) 
Article 252-1(1) Code des assurances 
TÜV RHEINLAND LGA PRODUCTS 
 
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Brief summary of the facts and procedure 
1 The applicant is taking action against the defendants for payment of damages for 
pain and suffering and the establishment of the obligation to pay compensation for 
further material and non-material damage.  
2 In autumn 2006, the applicant had her breast implants replaced for medical 
reasons. In this case, the applicant received implants from Rofil Medical 
Nederland B.V. (‘Rofil’), which were replaced again in 2012. The breast implants 
inserted into the applicant in 2006 were breast implants filled with unauthorised 
industrial silicone from the manufacturer Poly Implant Prothese S.A. (‘PIP’). PIP 
sometimes used industrial silicone from other manufacturers instead of the ‘NuSil’ 
material described in the product documents and specified and approved in the 
scope of the market authorisation. The implants were not placed on the market by 
PIP, but by the Dutch undertaking Rofil, which had, however, obtained them from 
PIP and merely packaged them and provided them with a package insert. 
3 Since October 1997, TÜV Rheinland LGA Products GmbH (‘TÜV Rheinland’) 
had been commissioned by PIP inter alia to carry out the conformity assessment in 
accordance with German, European and other international standards, working as 
a ‘Notified body’ within the meaning of Directive 93/42 (later within the meaning 
of Directive 2003/12). To that end, TÜV Rheinland carried out several 
supervisory audits of PIP between 1997 and 2010, which were each announced in 
advance. 
4 In March 2010, the French regulatory authority first discovered, during an 
inspection, that PIP was unlawfully using industrial silicone. The suspicion that 
Rofil implants could also be affected arose later. The recommendations of the 
health authorities were constantly widened and reinforced. In April 2010, the 
doctors who had used PIP silicone implants were recommended to merely inform 
the patients concerned and to no longer use those breast implants. From 6 January 
2012, the complete removal of those implants was recommended. 
5 PIP became insolvent and was liquidated in 2011. The founders of the undertaking 
were sentenced to four years’ imprisonment by a French court in December 2013 
for manufacturing and selling products that were dangerous to health. 
6 French law stipulates that the manufacturers of medical devices are to acquire and 
maintain liability insurance cover for the risks of damage to third parties arising 
from that activity. In the event of damage, the injured parties have a direct claim 
against the insurer under French law. However, the law does not give the 
manufacturers any precise specifications for the minimum level of insurance 
cover. The regulation on the insurance obligation does not contain any statement 
as to the geographic scope which the insurance cover must have in order to meet 
the statutory requirements. 
7 Under Article 252-1(1) of the Code des assurances, in the event that a prospective 
insurance customer does not find an insurer for the insurance cover to be acquired 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING - CASE C-581/18 
 
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thereby, the competent French authority, the Bureau central de tarification, is 
authorised to oblige an insurer to conclude a contract. In 2005, the legal 
predecessor of Allianz, AGD IARD, was obliged by the Bureau central de 
tarification to provide PIP with insurance cover. A contract was thereupon 
concluded between PIP and the legal predecessor of Allianz, with the Bureau 
central de tarification making some content specifications, including with regard 
to the amount of the insurance premiums. 
8 In the special contractual terms (‘clauses particulières’), it was agreed, under the 
heading ‘Geographic scope’, that the cover exclusively applies to cases of damage 
occurring in metropolitan France and the French overseas territories. This 
restriction was not objected to by the Bureau central de tarification. It is 
furthermore provided that, in the event of serial damages, the maximum cover 
amount per case of damage is EUR 3 000 000.00 and the maximum cover amount 
per insurance year is EUR 10 000 000.00. It is not disputed that the present case 
involves serial damage. 
9 The applicant brought action against Allianz inter alia for payment of damages for 
pain and suffering, reimbursement of expenses incurred and establishment that the 
defendants are obliged to compensate her for all the further material and 
non-material damage caused to her by the implantation of the faulty breast 
implants. 
10 Frankfurt am Main Regional Court (Germany) dismissed the action. The applicant 
filed an appeal against that judgment before the referring court. 
Principal arguments of the parties in the main proceedings 
11 The applicant is of the opinion that she is entitled to a direct claim under French 
law against Allianz, the provider of PIP’s liability insurance. Restricting the 
settlement obligations arising from the insurance contract to French national 
territories was contrary to EU law, as it constituted inadmissible indirect 
discrimination. 
12 Allianz argues that liability on its part was excluded, as the insurance cover 
provided in the insurance contracts between PIP and itself was exclusively 
restricted to cases of damage within French national territory. In addition, even if 
Allianz were to be liable for the applicant’s damages, she was not entitled to any 
claims, as the maximum cover amounts had since been reached. 
Brief summary of the basis for the reference 
13 The comments of the referring court on the basis for the reference are restricted to 
the procedural law relationship between the applicant and Allianz, as only this 
relationship is relevant under EU law. The decision in the case depends on the 
interpretation of Article 18(1) TFEU. 
TÜV RHEINLAND LGA PRODUCTS 
 
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14 In the view of the referring court, French law is applicable to the applicant’s 
claims against Allianz. In this case, the applicant invokes the direct claim against 
the insurer as provided for by French law. The insurer refers to the territorial 
restriction of the insurance cover. 
15 However, this raises the question of whether the restriction, laid down in the 
special contractual terms, of the cover to cases of damage occurring in 
metropolitan France and the French overseas territories is compatible with 
Article 18(1) TFEU. The referring court is inclined to answer this question in the 
negative. 
16 Article 18 TFEU applies only to situations governed by EU law in respect of 
which the Treaty lays down no specific prohibitions of discrimination (judgments 
of 4 September 2014, Schiebel Aircraft, C-474/12, EU:C:2014:2139, 
paragraph 20, and of 18 July 2017, Erzberger, C-566/15, EU:C:2017:562, 
paragraph 25). These are not involved here, which means that the general 
prohibition of discrimination is applicable. 
Article 18(1) TFEU forbids direct and indirect discrimination by reason of 
nationality (judgment of 23 January 1997, Pastoors and Trans-Cap, C-29/95, 
EU:C:1997:28, paragraphs 16 and 17). It is obvious that the restriction of cover to 
cases of damage occurring in metropolitan France and the French overseas 
territories constitutes indirect discrimination on the basis of nationality, because 
non-French patients are typically affected thereby. 
17 However, the question arises of whether the prohibition of discrimination is 
directed not only at the EU Member States and the Union institutions, but also at 
private parties (direct third-party effect of Article 18(1) TFEU, first question 
referred). As far as can be seen, the Court of Justice of the European Union has 
not yet explicitly decided this question. 
In consideration of the previous case-law of the Court of Justice on the prohibition 
of discrimination, the referring court takes the view that the general prohibition of 
discrimination in Article 18(1) TFEU also applies to private parties (cf. judgments 
of 6 July 2000, Angonese, C-281/98, EU:C:2000:296, paragraph 36, of 3 October 
2000, Ferlini, C-411/98, EU:C:2000:530, paragraph 50, of 14 July 1976, Donà, 
C-13/76, EU:C:1976:115, paragraphs 17 to 19, of 17 July 2008, Raccanelli, 
C-94/07, EU:C:2008:425, paragraph 45, of 28 June 2012, Erny, C-172/11, 
EU:C:2012:399, paragraph 36, and of 17 April 2018, Egenberger, C-414/16, 
EU:C:2018:257, paragraph 77). Even if a narrower view were to be adopted, 
according to which Article 18(1) TFEU should only apply between private parties 
when there is a power imbalance between them, which means that the individual 
citizens are barely able to escape from discrimination on grounds of nationality, 
the referring court takes the view that Article 18(1) TFEU would be applicable 
here, as the territorial restriction of cover is found in the particular insurance 
conditions of Allianz, which the applicant was in no way able to influence. 
SUMMARY OF THE REQUEST FOR A PRELIMINARY RULING - CASE C-581/18 
 
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18 If this question is to be answered in the negative and Article 18(1) TFEU is not 
applicable to relations between private parties, the question is, however, raised of 
whether in this case Article 18(1) TFEU precludes restricting cover to cases of 
damage occurring in metropolitan France and the French overseas territories 
because the competent authority, the Bureau central de tarification, did not object 
to the corresponding clause, as it would have been obliged to do with regard to 
Article 18(1) TFEU (second question referred). 
If it is assumed that the restriction of cover to cases of damage occurring in 
metropolitan France and the French overseas territories constitutes fundamentally 
inadmissible indirect discrimination on the basis of nationality, the question is also 
raised of whether there is justification for such indirect discrimination. The 
referring court takes the view that the case-law according to which indirect 
discrimination is justified if it is based on objective considerations that are 
independent of the nationality of the person concerned and proportionate to the 
legitimate aim of the provisions (judgment of 23 March 2004, Collins, C-138/02, 
EU:C:2004:172, paragraph 66) may also be applied to cases of third-party effect 
(third question referred). 
19 Economic interests such as, for example, the limiting of economic risk are unable 
to justify this discrimination, as this risk is already limited by the specification of 
maximum cover amounts. It is, however, irrelevant here whether the cases of 
damage occurred in France or another Member State. 
20 The referring court also asks about the effects of a breach of Article 18(1) TFEU 
if it were to be applicable. As Allianz argues that the maximum cover amounts 
were already reached, the applicant would not be entitled to any claims even in the 
event of a breach of Article 18(1) TFEU. In the view of the referring court, 
Article 18(1) TFEU would be deprived of its practical effectiveness (effet utile) if 
an insurance company firstly refuses payments for cases of damage occurring 
outside the territory covered by the insurance contract and could then – after the 
European Court of Justice’s finding that this is contrary to Article 18(1) TFEU – 
evade its payment obligation with reference to the maximum cover limit that has 
now been reached (fourth question referred).