The manufacturer of a hip prosthesis system (which was of a metal-on-metal design) for use in total hip replacement operations was sued by 313 individual claimants who alleged metal-wear debris damaged surrounding soft tissues necessitating revision surgery. The court found that the system was not defective and the claimants had not proved that it did not meet the level of safety that the public were generally entitled to expect at the time the prosthesis entered the market in 2002.

The court had to interpret the word ‘defect’ (‘defective’ is also used) in the UK Consumer Protection Act 1987. The Act describes a product as defective when it does not provide the safety which a person is entitled to expect taking all circumstances into account including the use of the product and the time when it is put into circulation.

A ‘defect’ therefore is defined by reference to the condition of the product itself rather than some fault or deficiency in it because it is not always possible to determine what precise mechanism caused the damage.

The court held that the inherent propensity of the prosthesis to shed metal debris through normal use, causing some patients to suffer an adverse reaction, was not a ‘defect’ in the product in this sense. The court also found that the claimants had failed to prove that the prosthesis did not meet the level of safety that the public were generally entitled to expect at the time when it entered the market in 2002. It has not been proved that the risk of failure within ten years was materially greater than a competing product and therefore there was no abnormal risk of damage at the time as alleged. The claim failed.

The South African Consumer Protection Act defines ‘defect’ more broadly to mean a material imperfection in the manufacture of the goods or any characteristic of the goods or components that renders the goods less useful, practicable or safe than persons generally would be reasonably entitled to expect in the circumstances. The court must however take into account the time when the goods were produced and supplied. The existence of a defect may not be inferred solely on the grounds that better goods have subsequently become available. Like any claim relying on a defective product, it must be shown that the goods were defective in relation to the available technology at the time of manufacturer and supply.

The case is Colin Gee and Others v Depuy International Limited.