Wilkes v Depuy International Ltd

Facts

The claimant underwent a total hip replacement in which the femoral component was a C-Stem made by the defendant. Some years later the stem fractured and he required revision surgery. He claimed that the prosthesis was defective under section 3 of the Consumer Protection Act 1987, which implements the Product Liability Directive, because its safety was not such as persons generally were entitled to expect.

Issue

How the court should determine whether a product is defective under section 3 of the Consumer Protection Act 1987, and in particular whether risk-benefit considerations, regulatory approval, warnings to clinicians and the avoidability of the risk are relevant; and whether the C-Stem was defective.

Held

Claim dismissed. The safety of the stem was not less than persons generally were entitled to expect, so it was not defective.

Ratio

• Whether a product is defective under section 3 of the Consumer Protection Act 1987 is determined by assessing, in the round, the level of safety persons generally are entitled to expect, taking into account all relevant circumstances, including the product's risks and benefits, any regulatory approval and standards, the information and warnings supplied to the relevant users, and whether the risk could have been avoided; no circumstance is excluded as a matter of law.

The judgments

Key reasoning

• The Directive and the Act impose liability without fault, but the standard is safety that persons generally are entitled to expect, which is not absolute safety; every medical device carries some risk.
• Section 3(2) requires the court to consider all circumstances, so there is no basis for excluding risk-benefit or avoidability considerations as legally irrelevant.
• Considering such matters does not convert the inquiry into negligence, because the question remains the safety of the product rather than the conduct of the producer.
• For a prescription medical device, the information available to the treating surgeon is part of the circumstances bearing on what safety can be expected.

Where it fits in the module

Under strict liability, Wilkes tests how strict product liability under the 1987 Act really is. By admitting risk-benefit and avoidability into the defect inquiry, it narrows the gap between strict liability and negligence, which is the central question in the debate about the Product Liability Directive. Read with A v National Blood Authority, it shows two competing judicial approaches to the same statutory test.

Criticisms

• Admitting risk-benefit and avoidability into the test for defect reintroduces fault-based reasoning by another name, undermining the strict character of the regime.
• A holistic, all circumstances approach gives little structure to the inquiry and makes outcomes hard to predict.
• Giving weight to regulatory approval risks allowing compliance with regulatory standards to function as a practical defence the Act does not provide.
• Treating warnings to surgeons as part of entitled expectations shifts the focus from what the public may expect to what professional intermediaries knew.