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Is There a Defect in the European Court's Defect Test? Musings about Acceptable Risk*

Published online by Cambridge University Press:  20 January 2017

Lucas Bergkamp
Lucas Bergkamp*
Affiliation:
Hunton & Williams, Brussels
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Abstract

Judgment of the Court (Fourth Chamber) of 5 March 2015 In Joined Cases C-503/13 and C-504/13, preliminary ruling in the proceedings Boston ScientificMedizintechnik GmbH v AOK Sachsen-Anhalt — Die Gesundheitskasse (C-503/13), Betriebskrankenkasse RWE (C-504/13)

On 5 March 2015, the European Court of Justice issued a preliminary ruling on two issues arising under the EU Product Liability Directive, which imposes objective, no-fault or strict liability, but not absolute liability, for defective products. Despite the wide range of issues arising under this directive, the Court has had only a few occasions to construe its ambiguous terms. This case, however, provided an opportunity to the Court to settle key issues relating to the defect test and the scope of damages compensable under the directive. As in other civil law cases, the question arises whether the Court's light treatment will provide a sound basis for the further development of product liability in Europe. The Court did not answer the questions posed by the referring court, but in some respects went beyond these questions and in other respects avoided the difficult issues raised thereby. As discussed in this note, the Court paints with a broad brush, and the test set forth in its judgment to determine whether a product is defective, may itself be defective.

Type
Case Notes
Information
European Journal of Risk Regulation , Volume 6 , Issue 2 , June 2015 , pp. 309 - 322
Copyright
Copyright © Cambridge University Press 2015

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Footnotes

*

Cf. George W. Conk, Is There A Design Defect In The Restatement (Third) of Torts: Products Liability?, Yale Law Journal, Vol. 109, No. 5, 2000, pp. 1087–1133.

References

1 Available at http://curia.europa.eu/juris/celex.jsf?celex=62013CJ0503&lang1=en&type=TXT&ancre=

2 Directive 85/374 of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products, OJ L 210, 07/08/1985, pp. 29-33, as amended, OJ L 141 20 (4.6.1999). http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1426872627268&uri=CELEX:01985L0374-19990604

3 Bundesgerichtshof, Beschluss VI ZR 284/12, 30. Juli 2013.

4 Bundesgerichtshof, Beschluss VI ZR 327/12, 30. Juli 2013.

5 Judgment, paras. 41 and 56(1).

6 Judgment, para. 37–38.

7 Judgment, para. 39.

8 Opinion of Advocate General Bot in Joined Cases C-503/13 and C-504/13, Boston Scientific, 21 October 2014, available at http://curia.europa.eu/juris/celex.jsf?celex=62013CC0503&lang1=en&type=TXT&ancre=.

9 Judgment, para. 40.

10 Judgment, para. 42.

11 Opinion, para. 71.

12 Recital 18, Product Liability Directive.

13 Article 4, Product Liability Directive.

14 See, for instance, the monograph by Taschner, the draftsman of the Product Liability Directive. Hans Claudius Taschner. Produkthaftung: Richtlinie des Rates vom 25. Juli 1985 zur Angleichung der Rechts- under Verwaltungsvorschriften der Mitgliedstaaten ueber die Haftung fuer fehlerhafte Produkte (85/374/EWG) mit Erlaeuterungen. Muenchen: Beck, 1986. For the three categories of defects, Taschner refers to Lorenz (1966). See also the leading treatise by Taschner and Frietsch. Hans Claudius Taschner, Edwin Frietsch. Produkthaftunggesetz under EG-Produkthaftungsrichtlinie: Kommentar. Second Edition. Muenchen: Beck, 1990.

15 Cf. Restatement (Third) of Torts, Product Liability (1997). § 2(b), and Restatement (Second) of Torts (1977), § 402(a). See also Kysar, D.A.. The Expectations of Consumers. Columbia law Review, Vol. 103, 2003, pp. 1700–1790 CrossRefGoogle Scholar. Ramsey, D.T.. Consumer Expectations test for Design Defect in California: From an Independent test of Limited Use to a Dangerous Substitute for Risk-Benefit Analysis. Tort & Insurance law Journal, Vol. 24, 1989, pp. 650–670 Google Scholar. Henderson, J.A. and Twerski, A.D.. Achieving Consensus on Defective Product Design. 83 Cornell Law Review, 1998, pp. 867–920 Google Scholar. Henderson, J.A. and Twerski, A.D.. Intuition and Technology in Product Design Litigation: An Essay on Proximate Causation. Georgetown Law Journal, Vol. 88, 2000, pp. 659–689 Google Scholar. Henderson, J.A. and Twerski, A.D.. Drug Designs Are Different. Yale law Journal, Vol. 111, 2001, pp. 151–181.CrossRefGoogle Scholar

16 Restatement (Third) of Torts, Product Liability (1997 ed.). § 2(b).

17 Aaron Twerski, and James A. Henderson Jr. Manufacturer's Liability for Defective Product Designs: The Triumph of Risk Utility. Cornell Law Faculty Publications. Paper 794, 2009, 74 Brook. L. Rev. 1061 2008–2009.

18 Taschner, Produkthaftung, pp. 65–72.

19 A and Others v. The National Blood Authority and Others, Queen's Bench Division, 26 March 2001, EWHC QB 446, 65 BMLR 1, (2001) 65 BMLR 1, [2001] 3 All ER 289, para. 31.vii.

20 Recital 6, Product Liability Directive.

21 Hodges, C., Product Liability – European Laws and Practice, Sweet & Maxwell, 1993, 52.Google Scholar

22 Taschner, Produkthaftung, p. 68.

23 Article 6.1, Product Liability Directive (French version).

24 Judgment, para. 37.

25 Taschner, Produkthaftung, p. 69.

26 Misuse of a product generally precludes recovery, except, possibly, if the misuse was foreseeable. Geddes, A., Product and Service Liability in the EEC, Sweet & Maxwell, 1992, 22.Google Scholar

27 On this point, Article 6(2) adds that “[a] product shall not be considered defective for the sole reason that a better product is subsequently put into circulation.” Article 6(2), Product Liability Directive.

28 H. Bartl. Produkthaftung nach neuem EG-Recht. Landberg am Lech: Verlag Moderne Industrie, 1989.

29 The learned intermediary doctrine serves as a defense to product liability suits in Canada and the US, but there is an exception for direct-to-consumer advertising. See http://www.thefederation.org/documents/pratt.htm#_edn1

30 Cf. Question and Answer by Mrs Flesch MEP to the European Commission, answered by Viscount Davignon on behalf of the Commission in June 1980. “The Commission agreed with the Honourable Member that nobody can expect from a product a degree of safety from risks which are, because of its particular nature, inherent in that product and generally known, e.g., the risk of damage to health caused by alcoholic beverages. Such a product is not defective.”

31 Article 6.2, Product Liability Directive.

32 On this defense, see the European Court's judgment in Commission v United Kingdom, C-300/95, [1997] ECR I-2649.

33 Article 7(e), Product Liability Directive.

34 Scholten v Sanquin, Rb. Amsterdam 3 February 1999, NJ 1999, 621.

35 Scholten v Sanquin, Rb. Amsterdam 3 February 1999, NJ 1999, 621.

36 Germany allows the manufacturer to invoke the state-of-the-art defense; only three Member States, Finland, Luxembourg and Spain, have used the option to exclude this defense. Hodges, C., Product Liability – European Laws and Practice, Sweet & Maxwell, 1993, 160.Google Scholar

37 A and Others v. The National Blood Authority and Others, Queen's Bench Division, 26 March 2001, EWHC QB 446, 65 BMLR 1, (2001) 65 BMLR 1, [2001] 3 All ER 289.

38 A and Others v. The National Blood Authority and Others, Queen's Bench Division, 26 March 2001, EWHC QB 446, 65 BMLR 1, (2001) 65 BMLR 1, [2001] 3 All ER 289, para. 67.

39 A and Others v. The National Blood Authority and Others, Queen's Bench Division, 26 March 2001, EWHC QB 446, 65 BMLR 1, (2001) 65 BMLR 1, [2001] 3 All ER 289, para. 71.

40 Commission v UK, Case C-300-95, Judgment of 29.5.1997, [1997] ECR I-2663, para. 27-28.

41 A and Others v. The National Blood Authority and Others, Queen's Bench Division, 26 March 2001, EWHC QB 446, 65 BMLR 1, (2001) 65 BMLR 1, [2001] 3 All ER 289, para. 78.

42 Meditel Pty Ltd v Courtney, 2003, 130 FCR 182, para. 78.

43 Meditel Pty Ltd v Courtney, 2003, 130 FCR 182, para. 49.

44 Fischoff, B., Lichtenstein, S. , Slovic, P.. Acceptable Risk. Cambridge: Cambridge University Press, 1981.Google Scholar

45 Article 1 juncto 9, Product Liability Directive.

46 Judgment, para. 47–49.

47 Note that the Court's answer to the question posed by the German court does not include the “all that is necessary” formula. It provides that “the damage caused by a surgical operation for the replacement of a defective product, such as a pacemaker or an implantable cardioverter defibrillator, constitutes ‘damage caused by death or personal injuries’ for which the producer is liable, if such an operation is necessary to overcome the defect in the product in question.” Opinion, para. 56. But the Court's reasoning is broader than this answer suggests.

48 The Product Liability Directive is “without prejudice to national provisions relating to non-material damage.” Article 9, Product Liability Directive.

49 Opinion, para. 39.

50 Producers will have no incentive to increase post-marketing monitoring beyond the regulatory minimum, however, unless the information it generates will effectively reduce their liability exposure.

51 Article 1, Product Liability Directive.

52 Article 4, Product Liability Directive.

53 Cf. Spier, J. (Editor). Unification of Tort Law: Causation. Principles of European Tort Law. The Hague: Kluwer Law International, 2000.Google Scholar

54 Opinion, para. 19.

55 Although Article 10(4) contemplates implementing measures, no such measures have been adopted.

56 Cf. Annex II, section 3.1, seventh indent; Annex IV, section 3; Annex V, section 3.1., 8th indent; Annex VI, section 3.1., 8th indent; Annex VII, section 4; Annex VIII, section 5, Medical Device Directive.

57 Guidelines issued by the European Commission state that “The Medical Device Directives require the manufacturer to report to the National Competent Authority any technical or medical reason leading to a systematic recall of devices of the same type by the manufacturer.” European Commission. Guidelines on a Medical Devices Vigilance System. Meddev 2.12-1 rev, 8 January 2013.

58 European Commission. Guidelines on a Medical Devices Vigilance System. Meddev 2.12-1 rev, 8 January 2013.

59 Directive 85/374 of 25 July 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products, OJ L 210, 07/08/1985, pp. 29-33, as amended, OJ L 141 20 (4.6.1999). http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1426872627268&uri=CELEX:01985L0374-19990604

60 Cf. European Commission. Guidance Document on the Relationship between the General Product Safety Directive (GPSD) and certain Sector Directives with Provisions on Product Safety, http://ec.europa.eu/consumers/consumers_safety/product_safety_legislation/general_product_safety_directive/index_en.htm

61 Compensation for pain and suffering is not covered by the Product Liability Directive, but subject to the applicable national law.

62 If a product liability insurance policy covers all damage to which liability attaches, the cost of surgical procedures to replace defective products will be covered. In that case, given that the scope of coverage has increased under the Boston Scientific ruling, insurance premiums will likely be subject to upward pressures.

63 Winterbottom v Wright (1842) 10 M&W 109.