Wilkes v DePuy International Limited: Major decision under the Consumer Protection Act 1987
Today, Hickinbottom J handed down judgment in Wilkes v DePuy International Limited  EWHC 3096 (QB) in which David Myhill appeared on behalf of the successful Defendant, DePuy.
This is a seminal decision concerning s2 and s3 of the Consumer Protection Act 1987 (“the Act”), which revisits and departs from the decision in A v National Blood Authority  3 All ER 289. In a detailed and carefully reasoned judgment, Hickinbottom J provides guidance on the proper approach to “defect” under s3 of the Act, and the circumstances which may be taken into account when assessing the level of safety that persons generally are entitled to expect.
Key aspects of the decision include:
- Clarification that the proper approach under the Act should commence by identifying whether the product suffered from a defect, rather than by identifying “the harmful characteristic which caused the injury” as suggested in A v NBA.
- A rejection of the rigid distinction between “standard” and “non-standard” products.
- Clarification that issues of avoidability of a defect, the risk-benefit balance, and cost are circumstances that can be taken into account.
- Confirmation that provision of instructions for use to a clinician amounts to a relevant circumstance.
- Acknowledgment that compliance with relevant standards and the grant of regulatory approval can be a relevant circumstance and may provide powerful evidence of the level of safety which persons generally were entitled to expect.
The Claimant received a modular total hip replacement in January 2007, produced by DePuy. Such a hip replacement comprises components which are matched together to form a prosthetic hip joint. In this case, a stainless steel femoral stem (known as a “C-stem”) was connected to a large metal femoral head by means of a device known as a taper sleeve adaptor. The neck of the stem featured a very fine groove (“the groove”) where it entered the taper sleeve adaptor, which allowed the stem to be used with both metal and ceramic femoral heads.
In January 2010, 3 years after implantation, the Claimant’s C-stem suffered a fatigue fracture at the grooved area on the neck of the stem. The Claimant brought a claim against DePuy in negligence and under the Act, alleging that the C-stem was defective owing to the presence of the groove. The Claimant alleged that the groove was unnecessary for connecting a metal femoral head, and that the effect of the groove was to create an unsafe stress concentration at the neck of the stem. He argued that he was entitled to expect that there would be no risk of fatigue fracture.
DePuy denied that the stem was defective. Fatigue fracture of femoral stems is a rare, but recognised risk. An express warning was given in instructions for use provided to the surgeon with the stem. The groove gave considerable benefit, allowing (amongst other matters) the same design of stem to be used with both ceramic and metal heads. It had been tested to a level in excess of the relevant British Standards, had met UK and European regulatory approval and had been given a CE marking. Moreover, the thread did not create an unsafe stress concentration.
The matter was listed for trial of a preliminary issue of whether the stem was defective under the Act.
Approach to the Act
The Court affirmed the fact that the approach to defect under the Act is objective, and held that the focus must be on whether the product suffered from a defect:
- The Court rejected the approach adopted by Burton J in A v NBA whereby the first step was to identify “the harmful characteristic which caused the injury”. This was likely to result in a circular enquiry, considering causation before identifying the defect. Instead, the focus must be on ascertaining whether the product suffered from a defect.
- Hickinbottom J agreed that the test as to the relevant level of safety was objective. The reference under the Act to whether “the safety of the product is not such as persons generally are entitled to expect” is a reference to an entitlement as a matter of law, not actual individual or even actual general expectation.
- In A v NBA, the Court approached this by considering the ‘legitimate expectation’ of persons generally. In Wilkes, this was held to be an unnecessary gloss: the words of the Act do not benefit from being re-described.
Circumstances to be taken into account
The Court held that the meaning of “all the circumstances” at s3(2) of the Act was wide and must mean “all relevant circumstances”. The Act does not impose any restriction on the considerations that may be taken into account. A flexible approach to the assessment of the appropriate level of safety was required. The circumstances which are relevant and the weight to be given to each will vary depending upon the particular facts of any case. In particular:
- The Court rejected the rigid classification of products as “standard” or “non-standard” adopted in A v NBA as unnecessary and undesirable. Whether a product conformed to the producer’s specification or relevant standards could be a relevant circumstance; however, a rigid classification of products into these categories was undesirable.
- A product’s risk/benefit balance is a relevant circumstance to be taken into account under the Act. Cost is also a potentially relevant factor in appropriate cases.
- Contrary to the approach adopted in A v NBA, the ease and extent to which a risk can be eliminated or mitigated may be a circumstance that bears upon the issue of the level of safety that the public generally is entitled to expect.
- Compliance with appropriate mandatory standards, and the grant of regulatory approval were also relevant circumstances. In an appropriate case, this could be powerful evidence of the level of safety that persons generally were entitled to expect.
- Warnings communicated to a medical intermediary (in this case, surgical instructions for use) are also a relevant circumstance.
Application to the facts
The Court determined the preliminary issue in favour of DePuy. The C-stem provided the level of safety that persons generally were entitled to expect. Key findings included:
- The evidence suggested that the groove did not concentrate stress in the neck of the C-stem to an unsafe level, as was demonstrated by the reported failure rate of 0.004%.
- There were benefits to the provision of a grooved taper for use with both ceramic and metal heads.
- The C-stem complied with all relevant standards, and fatigue testing was performed to a higher level than specified by the relevant British Standard.
- There was a small risk of fatigue failure in all femoral stems, as was reported in the literature. There was no evidence that the C-Stem had any higher risk than any other model.
- The instructions for use supplied with the product expressly warned of the risk of stem fracture.
A full copy of the decision may be downloaded here.
David Myhill was instructed by Andrew Hunn and Emily Brett of Kennedys, London.