The claimants in the most high profile product liability group action (Gee and Others v DePuy International Limited [2018] EWHC 1208) currently before the English courts have failed to prove that the hip implants in question were defective. The High Court considered how to interpret “defective” in great detail, but ultimately took a strict, and arguably more defendant friendly, approach. The judgment will therefore be welcomed by medical device manufacturers, and manufacturers more broadly, as supporting the careful policy balance struck in the Product Liability Directive between the interests of consumers and manufacturers.

Background

This judgment arose in the DePuy Pinnacle Metal on Metal Hip litigation, a group action brought by 312 individual claimants under the UK Consumer Protection Act, which incorporates the Product Liability Directive into English law. The judgment considered liability as a preliminary issue and contains detailed analysis of the meaning of “defect”, which will be relevant not only for other hip litigation cases but also for a wide range of other products. A copy of the judgment is available here.

This case is particularly significant because there is limited guidance available about the meaning of “defect” in the Product Liability Directive and via English or EU case law. In part, this is because it is relatively rare for major product liability disputes to be determined at trial by the English Courts or referred to the CJEU. Indeed, the European Commission acknowledged in its recent report on the Directive that the meaning of “defect” needs further clarification. It is likely that the European Commission will take into account the considered and detailed reasoning in the DePuy case when carrying out the next phase of its review of the Directive (see here for more information about this).

This case concerned the use of DePuy Pinnacle hip implants with a metal femoral head and a metal acetabular liner. The risk that patients could suffer an adverse reaction to metal debris was known and flagged in the product’s IFUs and technical brochures. The claimants argued that:

  1. the inherent potential for damage in normal use due to the product’s “tendency or propensity” to result in adverse reaction to metal debris requiring revision surgery constituted a defect; and
  2. in the alternative, the product had a materially higher risk of early failure than comparator products, which required the Court to consider what factors are legally relevant to that question and to critically assess the available evidence concerning failure rates of the product.

Key interesting points from the judgment

The claimants’ case failed for the following two reasons.

  1. The Court held it was “untenable” that the inherent propensity of a metal on metal hip to shed debris through normal use is a “defect” simply because some patients may suffer an adverse immunological reaction to the metal debris (this builds on the Wilkes v DePuy case rather than the A v National Blood Authority case); and
  2. On the claimants’ alternative case, the Court found that the claimants had failed to establish that the product carried with it an “abnormal risk” of damage.

We have summarised below some of the interesting points from the judgment.

1. Boston Scientific – The Boston Scientific case concerned pacemakers and an implantable cardioverter defibrillator, which the manufacturer recommended replacing or deactivating respectively. Given the abnormally high potential for damage with these products, the CJEU found that the standard of expected safety was particularly high. In the circumstances of that case, the CJEU found that where such products belonging to the same group have a potential defect, it is possible to classify all products in the group as defective without needing to show that a particular product in the group is defective.

Based on the Boston Scientific case, the claimants argued that the DePuy product was defective because of its “inherent potential for damage”.

The Court rejected this argument and emphasised that safety is:

“inherently and necessarily a relative concept, because no product, and particularly a medicinal product, if effective, can be absolutely safe… The public is not entitled to expect that a product which is known to have an inherently harmful or potentially harmful characteristic will not cause that harm, especially if (as in the present case) the product cannot be used for its intended purpose without incurring the risk of that harm materialising”.

The Court concluded that the claimants’ position was based on a misinterpretation of the Boston Scientific case. The Court highlighted that Boston Scientific was “not a case about the natural risks inherent in the use of a product under normal conditions for the purposes intended” but rather the abnormal potential for damage from “the significantly increased risk of failure” for the specific product group affected.

2. Relevant circumstances to assess safety – In relation to the claimants’ alternative case that the product had an abnormal risk of harm, the Court considered what circumstances can be taken into account when assessing the safety of a product.

The Court emphasised the flexibility of the test for “defect” and held that it was “entitled to have regard to all circumstances which may have a bearing on the assessment of the safety of the product” and those circumstances may differ depending on the product and the nature of the complaint. For example, those factors could include the avoidability of risk and the benefits of a product.

The Court also confirmed that the “existence of a learned intermediary and the information and warnings provided to that intermediary are plainly relevant circumstances” and compliance with regulatory standards can also be relevant. Whilst the weight to be given to each of those factors depends on the circumstances of each individual case, the Court acknowledged that compliance with regulatory standards can have “considerable weight” in appropriate circumstances.

3. Expert evidence pitfalls – The judgment contains serious criticisms of the evidence provided by some of the claimants’ experts, for example, for acting too much as an advocate for the claimants’ case rather than providing impartial and balanced evidence. The judgment should act as a reminder to claimants’ solicitors to ensure that their experts are properly instructed as to their duties to the Court.