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PIP Breast Implants, the EU's New Approach for Goods and Market Surveillance by Notified Bodies

Published online by Cambridge University Press:  20 January 2017

Barend van Leeuwen
Barend van Leeuwen*
Affiliation:
European University Institute (Florence): barend.vanleeuwen@eui.eu.
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Extract

With the New Approach for goods, the EU has created a regulatory framework for placing products on the market in which both public and private parties have an important role to play. The various cases which have been brought after the PIP breast implants scandal show the difficulties with trying to link this ex ante regulatory framework to potential liability for defective products. National courts have reached different conclusions about the scope of the obligations of certification bodies in the New Approach. Since these issues are about the fundaments of the construction of the New Approach, it would be desirable for the ECJ, and perhaps even the European legislator, to get involved.

Type
Articles
Information
European Journal of Risk Regulation , Volume 5 , Issue 3 , September 2014 , pp. 338 - 350
Copyright
Copyright © Cambridge University Press 2014

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References

1 Council Directive 93/42/EEC of 14th June 1993 concerning medical devices (“the Medical Devices Directive”).

2 Council Directive 85/374/EEC of 25th July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products (“the Product Liability Directive”).

3 AFSSAPS has now been replaced by the Agence Nationale de Sécurité du Médicament et des Produits de Santé.

4 European Commission, Scientific Committee on Emerging and Newly Identified Health Risks, ‘Preliminary Opinion on the safety of Poly Implant Prothèse (PIP) Silicone Breast Implants (2013 update)’, September 2013, http://ec.europa.eu/health/scientific_committees/emerging/docs/scenihr_o_038.pdf, last accessed on 25th March 2014.

5 For the German background and some estimates of the costs involved, see P. Rott and C. Glinski, ‘Ramsch–Brustimplantate: Ein Lehrstück europäischer Produktsicherheit’, forthcoming in Verbraucher and Recht.

6 By way of example, in Germany, AOK Bayern spent 50,000 euros on the removal of breast implants of 27 women: http://www.spiegel.de/panorama/justiz/fehlerhafte-brustimplantate-aok-bayern-verklagt-tuev-rheinland-a-921939.html, last accessed on 25th March 2014.

7 Commission Directive 2003/12/EC on the reclassification of breast implants in the framework of Directive 93/42/EEC on medical devices.

8 In this case, EN ISO 14630:2009 Non–active surgical implants – General requirements and EN ISO 14607:2009 Non–active surgical implants – Mammary implants – Particular requirements.

9 Articles 3 and 5 and Annex I of the Medical Devices Directive.

10 Article 17 of the Medical Devices Directive.

11 Article 11 and Annex XI of the Medical Devices Directive.

12 Galland, J.-P., ‘The Difficulties of Regulating Markets and Risks in Europe through Notified Bodies’, (2013) 3 European Journal of Risk Regulation 365–373, 368.CrossRefGoogle Scholar

13 Article 10 of the Medical Devices Directive.

14 Article 5.1 of Annex II of the Medical Devices Directive.

15 Azoulai, L., ‘The Court of Justice and the Social Market Economy: The Emergence of an Idea and the Conditions for its Realization’, (2008) 45 CML Rev 1335–1355.Google Scholar

16 Recitals of the Medical Devices Directive.

17 See Articles 14-16 of the Medical Devices Directive.

18 Case C-171/11, Fra.bo SPA v Deutsche Vereinigung des Gas– und Wasserfaches EV, Judgment of 12th July 2012 (not yet reported).

19 Schepel, H., ‘Case C-171/11, Fra.bo SPA v Deutsche Vereinigung des Gas– und Wasserfaches’, (2013) 9 ERCL 186–192, 191.CrossRefGoogle Scholar

20 van Leeuwen, B., ‘From Status to Impact, and the Role of National Legislation: The Application of Article 34 TFEU to a Private Certification Organisation in Fra.bo ’, (2013) 3 European Journal of Risk Regulation 405–409.CrossRefGoogle Scholar

21 Judgment of the Tribunal correctionel in Marseille of 14th November 2013, (N° minute: 7206/13), (N° parquet: 12048000148).

22 See also P. Rott and C. Glinski, ‘Ramsch–Brustimplantate: Ein Lehrstück europäischer Produktsicherheit’, forthcoming in Verbraucher und Recht.

23 See http://verbraucherrecht.at/cms/index.php?id=49&tx_ttnews%5Btt_news%5D=2808&cHash=b6e66dc3c6d7f0baa28f4f8aeed11bc7, last accessed on 25th March 2014.

24 Council Directive 90/314/EEC of 13th June 1990 on package travel, package holidays and package tours.

25 Case C-134/11, Blödel–Pawlik v Hansemerkur Reiseversicherung, Judgment of 16th February 2012 (not yet reported).

26 See Davies, G., ‘Freedom of Contract and the Horizontal Effect of Free Movement Law’ in D. Leczykiewicz and S. Weatherill (eds.), The Involvement of EU Law in Private Law Relationships, (Oxford, Hart Publishing, 2013), 53-71.Google Scholar

27 Case C-251/82, Eberhard Haug–Adrion v Frankfurter Versicherungs– AG, [1984] ECR 4277.

28 Judgment of Tribunal de Commerce in Toulon of 14th June 2012 (N° de rôle: 2010F00479).

29 See http://verbraucherrecht.at/cms/index.php?id=49&tx_ttnews%5Btt_news%5D=3052&cHash=3851bda0268a33af0935300e8916e546, last accessed on 11th April 2014.

30 Section 4(2) of the Supply of Goods and Services Act 1982.

31 G. Brüggemeier, ‘Implantation eines fehlerhaften Produkts in den menschlichen Körper: Zwei Vorlagebeschlüsse des Bundesgerichtshofs an den Europäischen Gerichtshof‘, forthcoming in ZEuP, V.

32 Directive 99/44/EC of the European Parliament and of the Council of 25th May 1999 on certain aspects of the sale of consumer goods and associated guarantees.

33 G. Brüggemeier, above n 31.

34 Case C-636/11, Karl Berger v Freistaat Bayern, Judgment of 11th April 2013, not yet reported. See K. Purnhagen, ‘Beyond Threats to Health: May Consumers’ Interests in Safety Trump Fundamental Freedoms in Information on Foodstuffs? Reflections on Berger v Freistaat Bayern’, (2013) 38 ELR 711-719.

35 Judgment of Tribunal de Commerce in Toulon of 14th November 2013 (N° de rôle: 2011F00517).

36 Judgment of Landgericht Frankenthal (Pfalz) of 14th March 2013 – 6 O 304/12, Judgment of OLG Zweibrücken of 30th January 2014 – 4 U 66/13.

37 Judgment of Landgericht Frankenthal (Pfalz) of 14th March 2013 – 6 O 304/12.

38 For a detailed discussion of the case in German, see ‘LG Frankenthal: Industriesilikon in Brustimplantaten – Kontrollpflichtverletzung durch die benannte Stelle’, MPR 2013, 134-140.

39 ‘LG Frankenthal: Industriesilikon in Brustimplantaten – Kontrollpflichtverletzung durch die benannte Stelle’, MPR 2013, 134-140, 135. In German: ‘Die bloße Gefahr einer Gesundheitsschädigung, insbesondere die her geltend gemachte erhöhte Krebsgefahr, ist nicht mit einer (eingetretenen) Gesundheitsschädigung i.S.d. § 253 Absatz 2 BGB gleichzusetzen under daher nicht schmerzensgeldauslösend’.

40 ‘LG Frankenthal: Industriesilikon in Brustimplantaten – Kontrollpflichtverletzung durch die benannte Stelle’, MPR 2013, 134-140, 136.

41 Council Directive 85/374/EEC of 25th July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products.

42 Cases C-503/13 and C-504/13, Boston Scientific Medizintechnik GmbH v AOK Sachsen– Anhalt and Betriebskran kenkasse RWE, Reference for a preliminary ruling from the Bundesgerichtshof lodged on 19 September 2013.

43 For a full discussion, see G. Brüggemeier, above n 31, II-III.

44 ‘LG Frankenthal: Industriesilikon in Brustimplantaten – Kontrollpflichtverletzung durch die benannte Stelle’, MPR 2013, 134-140, 139.

45 ‘LG Frankenthal: Industriesilikon in Brustimplantaten – Kontrollpflichtverletzung durch die benannte Stelle’, MPR 2013, 134-140, 136-138.

46 Article 3 of Annex II of the Medical Devices Directive.

47 Article 4 of Annex II of the Medical Devices Directive.

48 Article 5 of Annex II of the Medical Devices Directive.

49 ‘LG Frankenthal: Industriesilikon in Brustimplantaten – Kontrollpflichtverletzung durch die benannte Stelle’, MPR 2013, 134-140, 137.

50 Article 5.4 of Annex II of the Medical Devices Directive.

51 Ibid.

52 Ibid.

53 Judgment of OLG Zweibrücken of 30th January 2014 – 4 U 66/13.

54 Judgment of OLG Zweibrücken of 30th January 2014, II 2.2 b) aa) and bb).

55 The exact words are as follows: ‘Whereas medical devices should provide patients, users and third parties with a high level of protection and attain the performance levels attributed to them by the manufacturer; whereas, therefore, the maintenance or improvement of the level of protection attained in the Member States is one of the essential objectives of this Directive’.

56 Judgment of OLG Zweibrücken of 30th January 2014, II. 2.2 b), c) and d).

57 Cf. P. Rott and C. Glinski, ‘Ramsch–Brustimplantate: Ein Lehrstück europäischer Produktsicherheit’, forthcoming in Verbraucher and Recht.

58 Judgment of OLG Zweibrücken of 30th January 2014, II. 2.2 d).

59 Judgment of OLG Zweibrücken of 30th January 2014, II. 2.2 e).

60 Judgment of OLG Zweibrücken of 30th January 2014, II. 2.2 e).

61 Judgment of Tribunal de Commerce in Toulon of 14th November 2013 (N° de rôle: 2011F00517).

62 Judgment of Tribunal de Commerce in Toulon of 14th November 2013, p 140.

63 Judgment of Tribunal de Commerce in Toulon of 14th November 2013, p 141.

64 Judgment of Tribunal de Commerce in Toulon of 14th November 2013, p 141.

65 Judgment of Tribunal de Commerce in Toulon of 14th November 2013, p 141.

66 Judgment of Tribunal de Commerce in Toulon of 14th November 2013, p 141.

67 http://www.independent.co.uk/news/world/europe/french-legal-ruling-paves-the-way-for-compensation-for-women-with-faulty-pip-breast-implants-9075513.html, last accessed on 25th March 2014.

68 Judgment of Tribunal de Commerce in Toulon of 14th November 2013, p 141. In French: ‘Attendu qu’un autre événement et non des moindres, amplement médiatisé dans la grande presse et repris dans les revues spécialisées, est survenu en 2000, qu’ainsi à la suite d’une inspection inopinée dans les locaux de la SA PIP à La Seyne sur Mer, le FDA – Food and Drug Administration – a interdit sur le territoire US la vente des prothèses mammaires de marque PIP, adressant à celle–ci une lettre d’avertissement décrivant les irrégularités constatées, précisant même des violations dans le procès de fabrication et du contrôle qualité’.

69 Singh, S., ‘What is the Best Way to Supervise the Quality of Medical Devices? Searching for a Balance Between ex–ante and ex–post Regulation’, (2013) 4 European Journal of Risk Regulation 465–477, 465.CrossRefGoogle Scholar

70 For the background, see Commission Communication, ‘Safe, effective and innovative medical devices and in vitro diagnostic medical devices for the beneft of patients, consumers and healthcare professionals”, COM(2012) 540 final of 26th September 2012.

71 Commission Implementing Regulation (EU) No 920/2013 of 24th September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices.

72 Commission Recommendation of 24th September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (2013/473/EU).

73 Article 5.4 of Annex II of the Medical Devices Directive.

74 It should be noted that Article 6 of Annex XI provides for the possibility that the Member State in which the notified body is based assumes liability for the actions of notified bodies.

75 Recitals of the Medical Devices Directive.

76 C-222/02, Peter Paul and others v Bundesrepublik Deutschland, [2004] I-ECR 09425.

77 Directive 94/19/EC of the European Parliament and of the Council of 30th May 1994 on deposit-guarantee schemes.

78 Case C-222/02, Peter Paul, above n 76, paras 42-44.

79 Grundmann, S., ‘The Bankinter Case on MIFID Regulation and Contract Law’, (2013) 9 ERCL 267–280, 275-278.CrossRefGoogle Scholar

80 An analogy can again be made with Case C-222/02, Peter Paul, above n 76.