* United Kingdom, The High Court of Justice, Queen’s Bench Division, 21 May 2018 HQ 12X01255 & others

Identification of the case

• Part 1 of the Consumer Protection Act 1987

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

Summary of the case

The defendant in this case is Depuy International Limited, a company manufacturing the Pinnacle hip prosthesis system, a Metal on Metal (MoM) hip. 312 individuals complained of adverse reactions from the metal debris of the MoM hip. These effects necessitated that the individuals undergo revising surgery. After hearing clinical experts called before the Court to give their medical opinion, it was clarified that it was known in 2002 that all hip prostheses produce debris resulting from wear and tear, regardless of what material they are made from. DePuy informed the Court that they had made their patients aware of these affects and the risk therein. In 2013, following the release of guidance and advice from several associations including the British Orthopaedic Association and the Medicines and Healthcare products Regulatory Agency, DePuy made the decision to discontinue the manufacturing of this product.

The question posed was whether the risk known in 2002 - at the time of introduction of the hip to the UK market - about the MoM hip and the possibilities of ill effects from the metal debris were enough that the hip would fall below the objective safety threshold imposed by the 1987 Consumer Protection Act which implements the 1985 EU Product Liability Directive. The objective safety threshold specified by the Act is laid out in Section 3 therein and necessitates that in order to find a defect in a product the safety of the product must not be such as ‘persons generally are entitled to expect.’ In determining what persons are generally entitled to expect in relation to a product all circumstances shall be taken into account, including ‘the manner in which, and purposes for which, the product has been marketed, its get up, the use of any mark in relation to the product and any instructions for, or warnings with respect to, doing or refraining from doing anything with or in relation to the product.’ The Act prescribes that other factors such as the ‘time when the product was supplied by its producer to another’ are also relevant.

• Collective enforcement - Class Action

In answering the question of whether the risk known about the MoM hip in 2002, at the time of the product's introduction to the UK, was enough to rule that it falls below the objective safety threshold imposed by the 1987 Consumer Protection Act, the Court alluded to several CJEU judgments. Principally, the Sanofi judgment and the Boston Scientific judgment were relied on.

In dissecting the EU Directive and explaining the relation thereof to the principle of effectiveness, the Court referred to Sanofi when the CJEU made clear that ‘although the Directive left it to each Member State to establish detailed rules of proof and evidence for practical implementation of the Directive, which might vary depending on the type of product involved, national rules governing how evidence is to be adduced and appraised must not be such as to undermine either the apportionment of the burden of proof provided for under Article 4 or, more generally, the effectiveness of the system of liability provided for under the Directive, or the objectives pursued by the EU legislature by means of that system.’

The High Court reiterated the CJEU’s concern in Sanofi about national courts applying factual evidence in such a way that it would automatically presume that there was a causal link between the damage occurring and a product defect. In this context, the High Court established that interpreting the Consumer Act to remove the necessity for a claimant to prove a defect or the causal link between the damage and the defect ‘would be as much contrary to the objectives of the Directive.’

The claimants referred to the Boston Scientific judgment to make several arguments about the conceptualisation of the word ‘defect’ for the purpose of the Directive. The High Court found that the claimants had misinterpreted the judgment and ruled that ‘there is nothing in Boston Scientific to support the argument that the normal risks inherent in the use of a product can constitute a “defect”’.

The Court came to the conclusion that the ‘natural propensity’ of these hip prostheses to wear out and essentially fail could not be considered a ‘defect’ for the purposes of the Act. Thus, the producer of the prosthesis, DePuy Ltd, was not liable to the claimants.

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

The Charter was not relied on specifically by the Court nor the parties in this case. However, the Court does refer to the previous case law of the CJEU which mentions the Charter. For instance, the High Court relies on Boston Scientific Medizintechnik which mentions article 35 of the Charter.

• The obligation of the administration to give reasons for its decisions

There are no explicit references to the ECHR or the Charter in this case. However, the Court referred to sections of the EU Product Liability Directive which seek to ensure proper remedies to consumers in the context of effective protection. For example, the Directive requires that no contractual derogation should be permitted as regards the liability of the producer in relation to the injured person. Further, the Directive stipulates that claims for damages under national legal systems based on contractual or tortious causes of action should remain unaffected by the Directive in so far as these provisions also serve to attain the objective of effective protection of consumers. Moreover, the High Court made reference to CJEU case law which discusses effective consumer protection.

• Equivalence
• Effectiveness
• Proportionality

The principle of equivalence is never mentioned explicitly. Further, it is spoken of conversely. In other words, the Court stated that the ProductsLiability Directive provides for a ‘complete harmonisation’ and that the national legislature did not retain the power to provide consumers with a higher level of protection in relation to liability for damage caused by the defective products. In this context, the Court also refers to the CJEU in holding that ‘the Directive contains no provision expressly authorising the Member States to adopt or to maintain more stringent provisions in matters in respect of which it makes provision, in order to secure a higher level of consumer protection.’

The Court made a single reference to the principle of effectiveness when discussing the EU Directive. It held that the CJEU has been vigilant in ensuring that the rights conferred by the Directive are effective, irrespective of whether those rights are conferred on consumers or producers. The Court also noted that the CJEU has expressly allowed for Member States to establish rules on proof and evidence for the implementation of the Product Liability Directive so long as these national rules do not undermine the ‘the effectiveness of the system of liability provided for under the Directive, or the objectives pursued by the EU legislature by means of that system’, which includes the protection of consumer health.

The principle of proportionality is not explicitly referenced in the case. However, there are several references to the balancing of interests. For instance, the High Court relies on the CJEU Sanofi case in discussing causation when it stresses that ‘this is a matter for the national courts, subject only to ensuring that the rules adopted do not undermine the scheme of no-fault liability and create a different balance between the competing interests from the one that is set by the Directive’ (para 179).

Elements of judicial dialogue

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

• Judgment of the Court (Fifth Chamber) of 29 May 1997 Case C-300/95 Commission of the European Communities v United Kingdom of Great Britain and Northern Ireland
• Judgment of the Court (Fifth Chamber) of 25 April 2002 Case C-183/00 María Victoria González Sánchez v Medicina Asturiana SA
• Judgment of the Court (Fifth Chamber) of 25 April 2002 Case C-52/00 Commission of the European Communities v French Republic
• Judgment of the Court (Fourth Chamber) of 5 March 2015 Case C-503/13 and C-504/13 Boston Scientific Medizintechnik GmbH v AOK Sachsen-Anhalt – Die Gesundheitskasse and Betriebskrankenkasse RWE (Boston Scientific)
• Judgment of the Court (Second Chamber) of 21 June 2017 Case C-621/15 NW & Others v Sanofi Pasteur MSD (Sanofi Judgment)

Conform interpretation with EU law as interpreted by the CJEU Proportionality

To clarify the meaning of EU Directives and Member States national legislation thereon.

To respond to the claimants, who misinterpreted the CJEU case when defining the meaning of ‘defect’.

After several reliances on the CJEU’s case law the Court found against the claimants, who had failed to convincingly substantiate their case that the artificial hip prosthesis did not meet the level of safety required by the Consumer Protection Act 1978 which implemented the Product Liability Directive (85/374/EEC). Therefore, legislative reform stemming from the case seems highly unlikely.

Additional notes on the decision

Both the Sanofi case and Boston Scientific Medizintechnik have had a great impact on Gee & Ors v Depuy International Ltd [2018] EWHC 1208. In this context, it seems likely that the Gee & Ors v Depuy International Ltd case will influence national case law in the areas of product liability, consumer protection and product safery.