Module 17 2024

04/12/2024

Test for defectiveness?

UK: “… there is a defect in a product…if the safety of the product is not such as persons generally are entitled to expect ”. “ All the circumstances shall be taken into account, including… ” (a) the manner in which, and purposes for which the product has been marketed, its get-up, instructions or warnings; (b) what might reasonably be expected to be done with the product; and (c) the time when the product was supplied by the producer Section 3, Consumer Protection Act 1987 New EU PLD adds circumstances to consider: • Date of ‘pom’ or end of manufacturer’s control • Relevant product safety requirements, incl safety-related cybersecurity • Any recall/other relevant intervention by a CA or an EO related to product safety • The needs of the group of users for whom the product is intended

Regulatory compliance may not be seen as a benchmark for safety

There is no explicit risk/benefit criteria in the defect test

CJEU litigation advocates higher legitimate expectations for human implantables

Pressure on courts to infer the existence of defects simply from the alleged injuries

Revised EU PLD presumes defectiveness if:

• D fails to disclose evidence following court order • Product not compliant with mandatory PS requirements intended to protect against the risk of the damage allegedly suffered, or • Damage caused by obvious product malfunction during reasonably foreseeable use/under ordinary circumstances

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NEW EU PLD: BOP AND REBUTTABLE PRESUMPTIONS

Presumption of CAUSATION (causal link between the defect and the alleged damage):

Presumption of DEFECT, CAUSAL LINK, or BOTH where:

Presumption of DEFECT:

• D fails to disclose relevant evidence ; or • C “demonstrates” product non-compliance with

•

Despite the disclosure, and in consideration of “all relevant circumstances”, the C faces “excessive difficulties”— due to technical or scientific complexity — to prove the defectiveness, causal link, or both; and

• C “demonstrates” (1) the product is defective, and

mandatory PS reqs intended to protect against the risk of

the damage allegedly suffered by the C; or

(2) the damage caused is of a kind typically consistent with the defect in question

• C “demonstrates” it is likely that the Product is defective, or that a causal link between defectiveness/damage/both exists

• C “demonstrates” alleged damage was caused by an obvious product malfunction during reasonably

foreseeable use/under ordinary circumstances

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