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Certification of Medical Devices: Lessons from the PIP Scandal

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Part of the book series:Studies in European Economic Law and Regulation ((SEELR,volume 16))

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Abstract

In medical devices law, certification by private organisations substitutes pre-market control by public authorities. Certification of medical devices has attracted wide attention through the scandal around cheap and defective breast implants that were produced and distributed by the French producer Poly Implant Prothèse (PIP) and whose product design was certified by TÜV Rheinland as being safe. The scandal triggered litigation, in particular in German and French courts, that ultimately reached the Court of Justice. At the legislative level, the EU has reacted with numerous measures to improve the certification process, and also the accreditation of certification bodies. This chapter analyses and contextualises the public law control and complementary tort liability (de lege lata orde lege ferenda) as necessary elements of a functioning system of the safety of medical devices.

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Notes

  1. 1.

    See, for example, recital (4) of Dir 2001/95 on general product safety, [2002] OJ L 11/4. For medical devices, see the fifth recital of the Medical Devices Dir 93/42/EEC, [1993] OJ 1993, L 169/1.

  2. 2.

    See, for example, Art 6 of Dir 2001/83/EC on the Community code relating to medicinal products for human use, [2001] OJ L 311/67.

  3. 3.

    See Art 4(2) of Reg (EC) No 1829/2003 on genetically modified food and feed, [2003] OJ L 268/1.

  4. 4.

    See Art 28(1) of Reg (EC) No 1107/2009 concerning the placing of plant protection products on the market, [2009] OJ L 309/1.

  5. 5.

    For more details, see Hodges (2005), p. 53 ff; Schepel (2005), p. 227 ff; van Leeuwen (2017), p. 40 ff; Verbruggen and van Leeuwen (2018), pp. 394, 396 ff. VI Daskalova and MA Heldeweg, ‘Challenges for Responsible Certification in Institutional Context. The Case of Competition Law Enforcement in Markets with Certification’, in this volume, refer to this phenomenon as first party certification.

  6. 6.

    See, for example, Art 4 of the Medical Devices Dir 93/42/EEC.

  7. 7.

    See ECJ, 17/4/2007, Case C-470/03A.G.M.-COS.MET Srl v Suomen valtio and Tarmo Lehtinen, ECLI:EU:C:2007:213.

  8. 8.

    See ECJ, 8/5/2003, Case C-14/02ATRAL SA v Belgium, ECLI:EU:C:2003:265.

  9. 9.

    See also Singh (2013), p. 465.

  10. 10.

    See the 15th recital of Directive 93/42/EEC: ‘Whereas it is necessary, essentially for the purpose of the conformity assessment procedures, to group the devices into four product classes; whereas the classification rules are based on the vulnerability of the human body taking account of the potential risks associated with the technical design and manufacture of the device […].’ On differentiation between risk categories within the conformity assessment procedures see generally Kapoor and Klindt (2008), pp. 649, 650 f.

  11. 11.

    See Commission Dir 2003/12/EC on the reclassification of breast implants in the framework of Directive 93/42/EEC concerning medical devices, [2003] OJ L 28/43. Prior to that Directive, breast implants had been classified as class IIb medical devices.

  12. 12.

    For a chronic of the PIP scandal and the related problems, see the Commission Staff Working Document Impact assessment of the revision of the regulatory framework for medical devices, SWD(2012) 273 final, Appendix 11—Analysis of the PIP breast implants case in the light of the envisaged revision of the EU regulatory framework for medical devices (“stress test”). See also van Leeuwen (2014), pp. 338, 339; de Bruyne and Vanleenhove (2016), pp. 823, 833 f; Verbruggen and van Leeuwen (2018), p. 395 f.

  13. 13.

    See, in particular, Annex II Sec 3.3. and 4.3. of Dir 93/42/EEC.

  14. 14.

    [2007] OJ L 247/21.

  15. 15.

    For an overview, see Klümper and Vollebregt (2008), p. 57.

  16. 16.

    For an overview of German case law, see Rott and Glinski (2015b), p. 87.

  17. 17.

    BGH, 9/4/2015, VII ZR 36/14, (2015)Verbraucher und Recht 271 with case note Rott (2017a).

  18. 18.

    CJEU, 16/2/2017, Case C-219/15Elisabeth Schmitt v TÜV Rheinland LGA Products GmbH, ECLI:EU:C:2017:128; on which see Rott (2017b), p. 1146; Brüggemeier (2017), p. 527; Unger (2017), p. 299; Heynemann (2017), p. 98; Oeben (2017), p. 42; Degen (2017), p. 462; Wagner (2018), p. 130.

  19. 19.

    BGH, 22/6/2017, VII ZR 36/14, (2017)Neue Juristische Wochenschrift 2617 andVerbraucher und Recht with case note P Rott. See also Brüggemeier (2018), p. 191; Verbruggen and van Leeuwen (2018), p. 399 ff.

  20. 20.

    Ibid., margin notes 30 ff. For critique, see Brüggemeier (2018), p. 195, arguing that the BGH should have passed the case back to the previous instance court, the OLG Zweibrücken, for a proper inquiry into the facts.

  21. 21.

    See also Heynemann (2017), p. 100; Finn (2017), pp. 2590, 2592.

  22. 22.

    CJEU –Elisabeth Schmitt (n 18), para 51.

  23. 23.

    See also CJEU, 24/11/2016, Case C-662/15Lohmann & Rauscher International GmbH & Co. KG v BIOS Medical Services GmbH, ECLI:EU:C:2016:903, paras 35 ff.

  24. 24.

    See, for example, BGH, 31/3/2011, III ZR 339/09, (2011)Monatsschrift des deutschen Rechts 658.

  25. 25.

    See, in particular, OLG Zweibrücken, 30/1/2014, 4 U 66/13, (2014)Medizinprodukterecht 62, 65 with case note Handorn (2014), p. 84. See also Spickhoff (2014) margin note 3; Beyerbach (2015), pp. 522, 525.

  26. 26.

    See expressly OLG Zweibrücken (n 25).

  27. 27.

    For detailed discussion, see Rott and Glinski (2015a), p. 192. See also Spindler (2017) margin note 304; OLG Frankfurt, 13/1/2015, 8 U 168/13, (2015)Beck-Rechtsprechung 09145.

  28. 28.

    European Commission Communication on medical devices, COM(2003) 386 final, 6.1.

  29. 29.

    BGH, 9/4/2015, VII ZR 36/14, (2015)Verbraucher und Recht 268 with case note P Rott.

  30. 30.

    AG Sharpston, 15/9/2016, Case C-219/15Elisabeth Schmitt v TÜV Rheinland LGA Products GmbH, ECLI:EU:C:2016:694, para 40.

  31. 31.

    CJEU—Elisabeth Schmitt (n 18), paras 50 ff.

  32. 32.

    See, e.g., the Communication of the European Commission ‘Enhancing the Implementation of the New Approach Directives’, COM(2003) 240 final.

  33. 33.

    [2008] OJ L 218/30.

  34. 34.

    [2008] OJ L 218/82.

  35. 35.

    See, in particular, recitals (37) and (38) of Dec (EC) No 765/2008.

  36. 36.

    For more details, see Kapoor and Klindt (2009), p. 134.

  37. 37.

    Ibid., 65.

  38. 38.

    European Commission,Overview Report of a Series of FVO Missions Carried out in 23 Countries from January 2013 to November 2014 in the Framework of the Voluntary Joint Assessment Process for Notified Bodies Designated under the Medical Devices Directive, DG(SANTE)/2014-7666 – MR final.

  39. 39.

    See European Parliament, Resolution on defective silicone gel breast implants made by French company PIP, [2012] OJ C 332E/89, J.

  40. 40.

    See European Commission, ‘PIP Action Plan’,https://ec.europa.eu/growth/sectors/medical-devices/pip-action-plan_de.

  41. 41.

    [2013] OJ L 253/8.

  42. 42.

    [2013] OJ L 253/27.

  43. 43.

    COM(2012) 542 final.

  44. 44.

    In fact, the Commission was criticised for having exceeded its competences by regulating aspects of the administrative procedure as well as the supervision of notified bodies in detail, see Spickhoff (2014), margin note 7.

  45. 45.

    See recital (1). See also Spielberg (2009), p. A-1602.

  46. 46.

    See, for example, Newell and Watt (2012).

  47. 47.

    For critique, see Spickhoff (2014), margin note 10.

  48. 48.

    See Graf (2016a), p. 43; Eggenberger Stöckli (2015), p. 202. A list of withdrawn and expired notifications can be found at the NANDO website,http://ec.europa.eu/growth/tools-databases/nando/index.cfm.

  49. 49.

    See also Graf (2016a), p. 43.

  50. 50.

    For more details, see de Bruyne and Vanleenhove (2016), p. 832 f.

  51. 51.

    See Rott and Glinski (2015a), p. 205 f.

  52. 52.

    For more details, see Graf (2016a), p. 43 ff.

  53. 53.

    See European Parliament, Resolution on defective silicone gel breast implants made by French company PIP [2012] OJ C 332E/89, no 7.

  54. 54.

    [2017] OJ L 117/1.

  55. 55.

    See Art. 53 of Reg (EU) 2017/745.

  56. 56.

    For details, see Graf (2017a), p. 57.

  57. 57.

    [2011] OJ L 55/13.

  58. 58.

    See only AG Bot, opinion of 20/10/2014, joined cases C-503/13 and C-504/13Boston Scientific Medizintechnik GmbH v AOK Sachsen-Anhalt — Die Gesundheitskasse et al, ECLI:EU:C:2014:2306, para 38, relating to product liability law. See also Reich (2015), pp. 619, 624 ff.; de Bruyne and Vanleenhove (2016), p. 846 ff.

  59. 59.

    See Oeben (2017), p. 47 f.; Unger (2017), p. 303.

  60. 60.

    On the latter, see, for example, Jahn et al. (2005), pp. 53, 54 and 57 ff.

  61. 61.

    See Rott and Glinski (2015a), p. 209 f.; Wagner (2017), margin note 805; Wagner (2018), p. 134 ff. See also Kapoor and Klindt (2009), p. 136, concerning the situation prior to the 2008 reform.

  62. 62.

    ECJ, judgment of 20/9/2001, Case C-453/99Courage Ltd v Bernhard Crehan, ECLI:EU:C:2001:465, para 27.

  63. 63.

    CJEU –Elisabeth Schmitt (n 18), para 55. For further examples, see Reich (2015), p. 632 ff.

  64. 64.

    AG Sharpston –Elisabeth Schmitt (n 30), para 38 with fn 27. See also Reich (2015), p. 638; against van Leeuwen (2014), p. 349.

  65. 65.

    ECJ, judgment of 12/10/2004, Case C-222/02Peter Paul et al v Germany, ECLI:EU:C:2004:606.

  66. 66.

    Directive 2000/12/EC related to the taking-up and pursuit of the business of credit institutions [2000] OJ L 126/1.

  67. 67.

    [1994] OJ L 135/5.

  68. 68.

    See LG Bonn, 16/4/1999, 1 O 186/98, (2000)Neue Juristische Wochenschrift 815.

  69. 69.

    OLG Cologne, 11/1/2001, 7 U 104/00, (2001)Neue Juristische Wochenschrift 2724.

  70. 70.

    BGH, 16/5/2002, III ZR 48/01, (2002)Neue Juristische Wochenschrift 2464.

  71. 71.

    ECJ –Peter Paul (n 61), paras 42 f.

  72. 72.

    Ibid., para 44.

  73. 73.

    Ibid., paras 45 ff.

  74. 74.

    See also Reich (2015), p. 638.

  75. 75.

    Verbruggen and van Leeuwen (2018), p. 402, conclude that the safety of products and therefore the health and safety of patients was only a secondary aim of the Medical Devices Directive, whereas its primary aim was the promotion of the free movement of medical devices. For discussion, see also Reich (2008), pp. 85, 96.

  76. 76.

    See European Commission, Medical devices,https://ec.europa.eu/growth/sectors/medical-devices_de.

  77. 77.

    See OLG Karlsruhe, 20/4/2016, 7 U 241/14, (2016)Gesundheitsrecht 363; Cour d‘appel d‘Aix-en-Provence, 22/1/2015, No 2015/21. For a different view, see Micklitz et al. (2015), p. 37.

  78. 78.

    See also Rehmann (2010), margin note 3.

  79. 79.

    [2015] OJ L 326/1.

  80. 80.

    See also Graf (2016b), p. 214.

  81. 81.

    See, for example, Unger (2017), p. 303. See also Graf (2017b), pp. 486, 489.

  82. 82.

    On which see Schmidt (2015).

  83. 83.

    See also Heynemann (2017), p. 101, who fears that some Member States will be less strict than others.

  84. 84.

    See, for example, Sonnenberger and Autexier (2000), margin note 89; Verbruggen and van Leeuwen (2018), p. 403. On relevant heads of damage, see Fröding and Chivoret (2016), p. 181.

  85. 85.

    Tribunal de commerce de Toulon, 14/11/2013, 2011F00517 (Société GF ELECTROMEDICS & société EMI IMPORTACAO E DISTRIBUCAO LTDA & société J&D MEDICALS et autres intervenants volontaires); on which see Fröding (2014), p. 1; van Leeuwen (2014), p. 345 f; Rott and Glinski (2015a), de Bruyne and Vanleenhove (2016), p. 839. See also Tribunal de commerce de Toulon, 20/1/2017, 2014F00306; on which see Verbruggen and van Leeuwen (2018), p. 404.

  86. 86.

    Cour d‘appel d‘Aix-en-Provence, 22/1/2015, No 2015/21; on which see Fröding (2015), p. 162; de Bruyne and Vanleenhove (2016), p. 840; Verbruggen and van Leeuwen (2018), p. 404.

  87. 87.

    Arrêt n° 610, 10/10/2018 (15-26.093); Arrêt n° 615, 10/10/2018 (16-19.430).and Arrêt n° 616, 10/10/2018 (17-14.401), all available athttps://www.courdecassation.fr.

  88. 88.

    For potential grounds of liability under English law, see Glinski and Rott (2018); for Dutch law, see Verbruggen (2013), p. 39.

  89. 89.

    Reg (EC) No 864/2007 on the law applicable to non-contractual obligations (Rome II), [2007] OJ L 199/40.

  90. 90.

    Against de Bruyne and Vanleenhove (2016), p. 844.

  91. 91.

    See also Fulli-Lemaire (2015), pp. 99, 118.

  92. 92.

    See Unger (2017), p. 303.

  93. 93.

    See also Glinski and Rott (2019). See, however, van Leeuwen (2014), p. 440, who points at the inconsistency of a liability scheme with the New Approach.

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Rott, P. (2019). Certification of Medical Devices: Lessons from the PIP Scandal. In: Rott, P. (eds) Certification – Trust, Accountability, Liability. Studies in European Economic Law and Regulation, vol 16. Springer, Cham. https://doi.org/10.1007/978-3-030-02499-4_9

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