Wilkes v DePuy International Ltd [2016] EWHC 3096 (QB)

The claimant underwent surgery in 2007 to implant an artificial hip containing a steel femoral component manufactured by DePuy. Three years later the component, known as a C-Stem, fractured and further surgery was required. Metal debris was found around the joint when the device was replaced. The claimant alleged that the component had been defective when supplied and sought damages under the Consumer Protection Act 1987. The court considered technical testing, the forces acting on the implant and the information provided about risks when assessing the level of safety people were entitled to expect.

Did the fracture of the implanted C-Stem establish a defect under the Consumer Protection Act 1987, considering the safety people were generally entitled to expect?

Finding for D, that an ‘injured party’ did not have to prove negligence/fault, but still had to prove damage, a defect, and a causal relationship between them. Expected standards of safety could not be clearly defined because no medicinal product could be absolutely safe; the potential benefits and risks had to be balanced. There was no restriction on factors that the Court should consider in determining whether the safety of a product was acceptable. C failed to establish that the C-Stem was defective. It fell within the safety standard that persons were generally entitled to expect when it was put into circulation. It had been subject to greater pressures than it had been tested for, which was to a higher standard than the British standard. The fracture was a rare and unpredictable event, but it was a risk that had been expressly warned of in the instructions for use. Expert witnesses agree that the C-Stem complied with the standard for fatigue. The parameters of the test were clearly more demanding than those required by the British Standard. It is also uncontroversial that the material used for C-Stems also satisfied the relevant standard.

A medical device's failure does not itself prove a defect under section 3 of the Consumer Protection Act 1987. The court assesses the safety people are generally entitled to expect in all the circumstances, including relevant risks, benefits, warnings and technical evidence; proof of negligence is not required.

Wilkes demonstrates that strict product liability still requires proof of a defective level of safety and causation. Compliance with standards and warnings may be relevant, but neither is an automatic answer to every claim. The decision favoured a contextual assessment rather than assuming that an implanted device must never fail. Later appellate authority, including Hastings v Finsbury Orthopaedics, should be considered in a current product-liability analysis. Distinguish the manufacturer's statutory responsibility from a surgeon's separate duties concerning advice and treatment.