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Wilkes v DePuy (2016) – QBD departs from previous authorities on “Defect” claims under the Consumer Protection Act 1987 and confirms no requirement of absolute safety in all circumstances.
Mr Justice Hickinbottom’s seminal decision in Wilkes v DePuy (2016) EWHC 3096 (QB) marks a substantial departure from Burton J’s controversial approach to "defect" under section 3 of the Consumer Protection Act 1987 in A v National Blood Authority (2001) 3 All E.R. 289.
The decision provides clarity on the circumstances which may be taken into account when assessing the level of safety that persons are generally entitled to expect. Crucially, it confirms that there is no requirement for absolute safety in all circumstances and will provide useful ammunition when defending many product liability claims.
Mr Wilkes received a total hip replacement in January 2007. The prosthesis, manufactured by DePuy, comprised of a steel femoral stem connected to a metal femoral head. In January 2010, only three years after implantation, the prosthesis suffered a fatigue fracture at a grooved area on the neck of the stem requiring Mr Wilkes to undergo replacement surgery.
Mr Wilkes brought a claim against DePuy in negligence and under the 1987 Act. Whether Mr Wilkes could properly claim under the 1987 Act was determined by way of a preliminary issue:
The Court held that there was no "defect" in the product and Mr Wilkes could not therefore bring a claim against DePuy under the 1987 Act.
Under s3 (1) of the 1987 Act there is a "defect" in the product if it’s safety is "not such as persons generally are entitled to expect". In a departure to the approach adopted in A v National Blood Authority, the Court held that the focus must first be on whether the product suffered from a "defect" and not on identifying "the harmful characteristic which caused the injury".
The latter circular approach was rejected by the Court as it prematurely considered the issue of causation before properly identifying the defect. The Court also confirmed that the test as to the level of safety is objective. The level of safety persons "generally are entitled to expect" is not what a person or persons actually expect or generally expect, but what, as a matter of law, they are entitled to expect.
The Court rejected the approach adopted A v National Blood Authority which considered the "legitimate expectation" of persons generally in dealing with this question. This was held to be an "unnecessary and unhelpful gloss on the Act".
Pursuant to s3 (2) the 1987 Act "all the circumstances shall be taken into account" in determining "what persons generally are entitled to expect in relation to a product". The Court confirmed there is no restriction on the considerations that may be taken into account and a flexible approach is required. The relevant circumstances and the weight to be given to each will vary from case to case depending on the particular facts.
Some of the key points arising in Wilkes v DePuy when considering the appropriate level of safety of a product are as follows:
Mr Justice Hickinbottom concluded that the loading to which the stem was exposed was clearly greater than it could withstand, and for which it had been tested in accordance with the relevant British Standard, but this was the result of "a constellation of factors, each variable, which came together in a manner such that the neck of the stem fractured". The decision provides welcome clarification as to the correct formulation of "defect" under the 1987 Act, following the much criticised decision in A v National Blood Authority.
It accepts that the risk a product may cause injury may be outweighed by its benefits, even if that risk could have been eliminated by adopting a different design. The decision should also deter speculative claims, particularly when the product has obtained regulatory approval or has met relevant standards.