By: 13 January 2017
High Court clarifies law on product liability claims in landmark hip replacement case

The High Court has ruled that just because a product has caused an injury, it does not automatically lead to a successful product liability claim.

Lawyers acting for the defendant DePuy International in the case of Wilkes v DePuy International Limited [2016] EWHC 3096 (QB), said that the ruling will provide manufacturers with some comfort that the 1987 Consumer Protection Act does not impose a standard of absolute safety where claimants sustain injury or damage in all circumstances – and should deter speculative claims as well.

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. The implant was manufactured by DePuy.

Mr Justice Hickinbottom’s 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.

Under the 1987 Act, a product is said to be defective 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”.

“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,” said the judge.

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”.

He concluded by saying 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 Davies, a partner at law firm Kennedys who acted for DePuy, said: “The court’s decision will provide clarity to producers and claimants as to the correct formulation of defect under the Act. It will offer manufacturers some clarity that the Act will not impose strict liability where claimants sustain injury and/or damage in all circumstances, where for example as here a known but rare side effect or complication from the use of a product occurs where that risk had been warned about and the overall benefits outweigh the small risk.

“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.”