Product safety and ‘entitled expectation’

In Hastings v Finsbury Orthopaedics and Another [2022] UKSC 19, the Supreme Court dealt with the issue of whether a prosthetic hip was defective for the purposes of the Consumer Protection Act 1987 (CPA). The appellant had undergone a total hip replacement in 2009 and the prosthesis had been manufactured by the respondents. In 2012, he underwent revision of the implant in his left hip. He sought damages under section 2 of the CPA through the Scottish courts, claiming that the original replacement hip was defective. At first instance, the Outer House decided that he had failed to prove that the product was defective, and his reclaiming motion was refused by the Inner House. He appealed to the Supreme Court.

Lord Lloyd-Jones (with whom the rest of the court agreed) considered the CPA, which implemented the directive of the Council of the European Communities, dated 25 July 1985 (No 85/374/EEC). Section 3 defined a ‘defect’ as being present if the safety of the product was not such as persons generally were entitled to expect. The parties had agreed to put the following question to the court: did the admitted inherent propensity of metal on metal (MoM) hip prostheses to shed metal debris through wear in use and the admitted risk that some patients might suffer an adverse reaction to such metal debris that might necessitate early revision, render the product less safe than persons generally were entitled to expect and thus defective within the meaning of the CPA?

Lloyd-Jones explained the CPA principles:

• The directive and the CPA had introduced a system of no-fault liability.
• The test of whether a product was defective was whether the safety of the product was not such as persons generally were entitled to expect – the ‘entitled expectation’.
• What persons generally were entitled to expect was assessed, having regard to all the circumstances which were factually or legally relevant to the evaluation of safety.
• In determining whether a product met the level of safety persons generally were entitled to expect, the court was entitled to have regard to everything now known about it that was relevant to that enquiry, irrespective of whether that information was available at the time it was put on the market or had come to light subsequently.
• The burden of proof was on the consumer to establish a defect and a causal link to the injury.

It was agreed that the statistical evidence presented to the court was not sufficient (of itself) to enable the court to conclude that the product was defective. However, the appellant presented his case on two main bases.

First, he sought to prove that the product was defective by demonstrating design flaws. Both parties relied upon expert evidence in four fields: orthopaedics, biomechanics, immunology/toxicology and histopathology. That case had been rejected at first instance, and there had been no appeal against the court’s finding.

The second basis was to rely on matters that were said to constitute prima facie evidence that the product was defective. Here the claimant relied in particular on: (a) expressions of professional concern by the orthopaedic community; (b) the conduct of the respondents in withdrawing the product from the market; and (c) the notices and alerts issued by regulators and by the respondents. The appellant relied in particular on three further matters.

• First, the principle of effectiveness in EU law. This principle required that EU rules did not render the exercise of those rights practically impossible or excessively difficult.
• Second, the directive must be interpreted so far as possible in favour of the party to whom protection was intended to be given, namely the consumer.
• Third, the appellant submitted that he had been set an impossible task, that of proving his case by statistics that were not available to him on account of the producer’s actions in withdrawing the product from the market. Such circumstances called for a benevolent application of the provisions of the CPA.

Lloyd-Jones said that in this case the nature of the product was such that there could be no entitlement to an absolute level of safety. It was natural for such a prosthesis to wear and shed metal debris that could cause soft tissue damage. This (of itself) could not be a defect. Agreed expert evidence showed that there was no reliable statistical evidence that the revision rate of the product was out of line with the relevant benchmarks. The generalised expressions of professional concern did not assist the appellant. The hip prosthesis was only one type of a series of hip prostheses produced by the respondents, and there was a wide range of revision rates with these prostheses in general. The withdrawal of the allegedly defective product did not entitle the court to draw an adverse inference from the decision of the respondents to withdraw it from the market, particularly as that decision appeared to be based on commercial considerations.

Lloyd-Jones referred to a review article from 2013, which said that MoM replacement became very popular in the middle of the last decade, and there was evidence that it worked well on young active men. However, the failure rates of MoM hip replacements in certain classes of people were significantly higher than expected. On the face of it, the warning notices and the statistics on which they were based appeared to support the existence of a failure to meet the standard of the applicable entitled expectation. However, they could not of themselves be determinative of the issue of whether there was a breach of that entitled expectation. In assessing whether there had been compliance with an entitled expectation the court was entitled and required to have regard to material available in 2019, when the evidence was presented to the court, which was not available in 2012 when the notices were issued. That evidence undermined the prima facie evidence summarised above.

The appeal would be dismissed.

Malcolm Johnson is legal director and head of child abuse compensation claims at Lime Solicitors, London