The fact that a product has caused an injury does not automatically lead to a successful product liability claim, the High Court ruled yesterday in a major case where we acted for the defendant.
Mr Justice Hickinbottom’s decision in favour of the defendant in Wilkes v DePuy International Limited  EWHC 3096 (QB) will provide manufacturers with some comfort that the 1987 Consumer Protection Act does not impose a standard of absolute safety where claimants sustain injury and/or damage in all circumstances – and should deter speculative claims as well.
The ruling also provides a clearer statement of the law than the previous leading authority, Mr Justice Burton’s controversial 2001 decision in A v National Blood Authority.
Wilkes involved a claim made by the recipient of a hip replacement who said that part of the prosthesis, the femoral hip stem, was defective under the Act because it fractured three years after implantation, requiring surgery to remove and replace the prosthesis. It was manufactured by DePuy.
Under the 1987 Act, there is a defect in a product if its safety is “not such as persons generally are entitled to expect”, taking into account “all the circumstances”.
In the 2001 case, the parties had re-described this as a “legitimate expectation” of safety, but Hickinbottom J described this as “an unnecessary and unhelpful gloss on the Act” and held the categorisation of products into ‘standard’ and ‘non-standard’ as “unnecessary and undesirable”.
He said: “In considering whether a product suffered from a defect, the court must assess the appropriate level of safety, exercising its judgment, and taking into account the information and the circumstances before it, whether or not an actual or notional patient or patients, or indeed other members of the public, would in fact have considered each of those factors and all of that information.”
He stressed that safety is “inherently and necessarily a relative concept” and there cannot be a “sensible expectation that any medicine or medicinal product is entirely risk-free”.
Among the key factors here were the regulatory approval, which whilst not of itself providing a complete or automatic defence, the judge considered to be “powerful evidence that a product provided the level of safety persons were entitled to expect”. There was also the risk-benefit analysis that must attach to certain products – do the benefits sufficiently outweigh the risks? The Court also took into account the warnings that were supplied with the product which, crucially, warned of the risk of fracture.
Hickinbottom J concluded that the loading to which the stem was exposed was “clearly greater” than it could withstand, and for which it had been tested, 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”.
Crucially, this was not down to a defect in the stem at the time it was put on the market. The claimant had failed to convince the court that its safety was not such as persons generally were entitled to expect.
Trevor, who acted for DePuy, added: "The decision will also guide claimants to consider the merits of claims made against manufacturers of products where those products have obtained regulatory approval and have met appropriate standards, which in turn should reduce the number of speculative claims brought under the Act.”