* United Kingdom, Inner House of the Court of Session, first division, 26 January 2021 [2021] CSIH 6

Identification of the case

• Consumer protection (art. 38 CFREU)
• Right to an effective remedy and to a fair trial (art. 47 CFREU)

• The Consumer Protection Act 1987 Sections 1-4

• Directive No. 85/374/EEC (The Product Liability Directive) Articles 6 and 7

Summary of the case

The claimant had undergone a left and right-sided metal on metal (MoM) total hip replacement in 2009. He claimed that he had suffered loss and damage due to the use of the Mitch/Accolade MoM prostheses and that the product was therefore defective under the provisions of the Consumer Protection Act of 1987, which implemented the EU Product Liability Directive. A preliminary hearing was restricted only to the question of the propensities and risks inherent in MoM total hip replacements and whether the product was defective in terms of the Act. The lower court relied on an extensive number of experts, literature and research in forming its opinion. The Lord Ordinary issued his opinion on 26 November 2019 and acquitted the defendants.

An appeal by the claimant was heard by the Inner House of the Court of Session, which is the Supreme Civil Court of Scotland. The parties challenged many views of the Opinion. The claimant built its case upon the consumer’s reasonable expectations (para 37), the fair allocation of risk between consumer and manufacturer (para 39), the object of the Directive (para 40) and the incorrect application of the evidence. The defendants agreed with the Lord Ordinary and submitted inter alia that consumer protection was not the primary objective of the Directive (para 58). The Court held that the Lord Ordinary’s decision that the prima facie evidence was not supported by up-to-date information was sufficient. Thus, the appeal was refused.

• Civil judicial enforcement

Appeal against the dismissal of the claimant’s case

The deciding court recognised the underlying problem the Lord Ordinary had concluded in the lower court: The question was not what persons generally expect from the prostheses or what the pursuer expected from his prosthesis. It was what, objectively assessed, persons generally were entitled to expect in terms of safety from this type of prosthesis. The scope of the preliminary hearing was restricted to whether the Mitch/Accolade prosthesis was defective in terms of Section 3 of the Consumer Protection Act 1987 because of the propensity of MoM prostheses to shed metal debris, which in turn carried with it a risk of adverse reaction in some patients. (Para 65). The question was: did that propensity render them less safe than persons generally were entitled to expect?

The court assessed the strict liability within the meaning of both the Consumer Protection Act and the Directive and concluded that the liability for a defective product is strict, but a claimant has to prove the existence of a defect as defined by the Act (para 66). It also concluded that the Lord Ordinary had not placed any excessively exacting standards on the claimant and that using the standard of the balance of probabilities was the correct test to apply (para 68).

The Lord Ordinary decided the case on the basis that the claimant had failed to discharge the burden of proof upon him to demonstrate the existence of a defect. He concluded that the Mitch/Accolade prosthesis was not “less safe” than persons generally were entitled to expect and, therefore, not “defective” (para 69). In addition, the court admitted that “[i]t may be unfortunate that the Lord Ordinary was not able to make a positive finding on whether a defect existed in the Mitch/Accolade product other than by reference to a failure to overcome the burden of proof” (para 69). Thus, it held that the fundamental problem arising was whether after consideration of the evidence the Lord Ordinary was entitled to conclude that notwithstanding this prima facie evidence, the claimant had failed to overcome the burden of proof.

Regarding that question, the court held that the Lord Ordinary justified the core of his process of reasoning by reference to the material which was placed before him (para 71). The court dismissed the claimant’s arguments that the Lord Ordinary had failed to consider pieces of evidence, namely, a British Medical Journal article and English case law, which the court disregarded as having no application in the case at hand (paras 74, 75).

Moreover, the claimant argued that the case had not been based upon a consideration of statistical data but on the elements of “prima facie evidence” as a response to the Lord Ordinary’s acceptance of the unchallenged evidence by expert witness Professor Platt. However, according to the court, the Lord Ordinary was not using it to prove that the Mitch/Accolade prosthesis was not defective but to demonstrate that the prima facie evidence was not supported by up-to-date information (para 78). For these reasons, the court held that the appeal must be refused.

Role of the Charter and role of the general principles on enforcement

According to Article 38 of the Charter, the Union policies shall ensure a high level of consumer protection. Article 47 of the Charter establishes a right to an effective remedy and a fair trial. The court established in paragraph 68 that the Lord Ordinary did not place excessive obstacles in the way of the claimant, which would be against the universal principle of a fair and proportionate trial.

• Right to access a court
• Right to a fair trial
• Right to a public hearing within a reasonable time

The Consumer Protection Act 1987

1. Purpose and Construction.

(1) This part shall have effect for the purpose of making such provision as is necessary in order to comply with the product liability Directive and shall be construed accordingly...

(2) ...’the product liability Directive’ means the Directive of the Council of the European Communities, dated 25 July 1985, (No. 85/374/EEC) on the approximation of the laws, regulations and administrative provisions of the member States concerning liability for defective products.

…

2. Liability for defective products.

(1) ... where any damage is caused wholly or partly by a defect in a product, every person to whom subsection (2) ... applies shall be liable for the damage. (2) This subsection applies to –

(a) The producer of the product... 3. Meaning of ‘defect’.

(1) ... there is a defect in a product... if the safety of the product is not such as persons generally are entitled to expect; and for those purposes ‘safety’... shall include ... safety in the context of risks of... personal injury.

(2) In determining... what persons generally are entitled to expect in relation to a product all the circumstances shall be taken into account, including –

(a) the manner in which, and purposes for which, the product has been marketed ... and any instructions for, or warnings with respect to, doing or refraining from doing anything with or in relation to the product;

(b) what might reasonably be expected to be done with or in relation to the product; and

(c) the time when the product was supplied by its producer to another; and nothing in this section shall require a defect to be inferred from the fact alone that the safety of a product which was supplied after that time is greater than the safety of the product in question.

...

4. Defences.

(1) ...it shall be a defence for [the producer] to show –

...

(e) that the state of scientific and technical knowledge at the relevant time was not such that a producer of products of the same description... might be expected to have discovered the defect...

Article 38 CFREU ensures the safeguarding of consumer protection on a Charter level

• Effectiveness
• Proportionality

The principle of effectiveness in the area of consumer protection is central in the case. The court had to find a fair apportionment of risk between a consumer and a manufacturer in order to find a correct balance between the rights and liabilities of the parties and to establish a defect in order to effectively ensure a high level of consumer protection.

The principle of proportionality is central in consumer protection cases as the status of a consumer is generally recognised as being vulnerable and unbalanced compared to a manufacturer. Thus, the Union has used its powers to especially protect the consumers in the single market area.

Moreover, the court stated that the claimant must be able to access the courts and have his claim adjudicated upon in a proportionate manner and that unconquerable or excessive obstacles should not be placed in the way (para 68). The court held that there was no indication that the Lord Ordinary placed any such obstacles in the way of the claimant.

Elements of judicial dialogue

• Dialogue among same level national courts within the same Member State

• Direct dialogue between CJEU/ECtHR and National court (out of preliminary reference procedure)
• Dialogue between high court - lower instance court at national level

• C-621/15 Sanofi
• C-310/13 Novo Nordisk Pharma v S
• C-503/13 Boston Scientific Medizintechnik v AOK
• C-154/00 Commission v Greece
• C-183-00 Sánchez v Medicina Asturiana
• C-300/95 Commission v United Kingdom

The court did not explicitly refer to any CJEU cases. However, as it resolved and analysed the Lord Ordinary’s rationale, it had to consider his opinion as a whole. Therefore, the cases the Lord Ordinary cited in his opinion were relevant to the court's reasoning.

As the scope of the subject was relevantly specific, only a handful of cases were cited in the case. Both parties cited the same CJEU cases, for example:

• C-503/13 Boston Scientific Medizintechnik v AOK (ref. in paragraph 24), which considered the meaning of a defective product according to the Product Liability Directive.

The lower court and the deciding court referred to several EU and national cases when interpreting the current framework of product liability and consumer protection in striking a balance between them.

Confirmation of the lower court’s decision

Additional notes on the decision

The case is too recent to know its effect yet, but it is considered to be a significant judgment on what constitutes a defect under the Consumer Protection Act 1987, following the landmark decision of Gee v DePuy International (2018).