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.

Background

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:

Mr Wilkes contended that the product contained a "defect" as defined in s3 of the 1987 Act. He alleged that the design, in particular the presence of the groove, made it susceptible to failure which should have been eliminated by adopting a different design. He argued that the groove was unnecessary for connecting the metal femoral head, that it created an unsafe stress concentration and he was entitled to expect that there would be no risk of fatigue fracture in the prosthesis. DePuy denied that the stem was defective as fatigue fracture of the femoral stem is a rare but recognised risk. An express warning was given in the instructions for use provided with the prosthesis to the surgeon. The groove provided a considerable benefit as it allowed the same stem to be used with both ceramic and metal femoral heads. The prosthesis had received UK and European regulatory approval, been tested to a level in excess of the relevant British Standards and been given a CE marking. 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. Approach to the 1987 Act

Under s3 (1) of the 1987 Act there is a "defect" in the product if its safety is "not such as persons generally are entitled to expect". In a departure to the approach...