Supreme Court: Defective Hip Replacement

The appellant underwent a total hip replacement with a metal-on-metal (MITCH-Accolade) prosthetic hip after which he claimed that the replacement hip was defective and sought damages under the Consumer Protection Act 1987 (CPA).

Before the Supreme Court he sought, firstly, to prove that the product was defective by demonstrating certain design flaws. Secondly, he relied on matters which were said to constitute prima facie evidence that the product was defective: Hastings v Finsbury Orthopaedics Ltd & anor (Scotland) [2022] UKSC 19: Lord Reed P, Lord Kitchin, Lord Stephens, Lady Rose, Lord Lloyd-Jones

The Outer House held at first instance that the appellant had failed to prove that the product was defective for the purposes of the CPA.

Following rejection by the Inner House of the appellant’s reclaiming motion [appeal], before the Supreme Court the appellant relied on three matters: (1) expressions of professional concern by the orthopaedic community; (2) the conduct of the respondents in withdrawing the product from the market; (3) certain notices and alerts issued by regulators and by the respondents.

The respondents had relied upon unchallenged evidence of biostatics from Professor Platt. The parties agreed that his evidence demonstrated that there was no reliable statistical evidence that the revision rate of the product was out of line with the relevant benchmarks. The revision rate of a prosthesis was the percentage chance that revision surgery would be required to replace the prosthesis in a given time period.

The CPA and the EU Directive which it implemented had introduced a system of no-fault liability in respect of defective products. 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 burden of proof was on the consumer to establish a defect and a causal link to the injury.

Giving the unanimous judgment of the Court, Lord 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 a prosthesis of this sort to wear and to shed metal debris that could cause soft tissue damage, so this of itself could not be a defect.

The test of entitled expectation was agreed by the parties and held by the Lord Ordinary to be whether, subject to de minimis considerations, the level of safety of the product would not be worse, when measured by appropriate criteria, than existing non-Metal on Metal (MoM) products that would otherwise have been used.

The appellant failed to establish his case on a statistical basis. The question which arose for consideration was whether the rejection by the Lord Ordinary of the statistical evidence nevertheless left prima facie evidence on which the appellant could rely to prove his case. In the Court’s view it did not.

The respondents accepted that serious professional concerns came to be expressed among orthopaedic surgeons in relation to high revision rates and potential difficulties in carrying out revision operations in cases of MoM prostheses. That evidence and the expressions of concern related, however, to the performance of MoM prostheses in general. It was not disputed that the reported revision rates of MoM prostheses varied from product to product.

Secondly, the Lord Ordinary found, as he was clearly entitled to, that the withdrawal of the product was brought about by commercial considerations. As a result, the circumstances and reasons for the withdrawal of the product from the market did not provide any support for the appellant’s case that the product was defective.

The third category of evidence on which the appellant relied concerned the notices issued in relation to the product. The reasoning which led Professor Platt to the conclusion that the appellant’s case of breach of entitled expectation was not made out on a statistical basis, applied equally to this category of prima facie evidence.

The Lord Ordinary’s conclusions on the statistical evidence were not neutral; they contradicted the appellant’s case founded on statistics. Rather than leave this category of prima facie evidence unchallenged, Professor Platt’s evidence undermined it.

In expressing his conclusion on entitled expectation, the Lord Ordinary considered that “the pursuer [claimant] has not proved, on a balance of probabilities” his case in relation to survivorship or an increased risk of an unsatisfactory outcome of revision surgery. But expressing his conclusion in terms of the burden of proof did not invalidate the reasoning. The short point was that the appellant failed to prove the existence of a defect.

Ultimately, the appeal was no more than an attempt to appeal against the findings of fact of the Lord Ordinary and was dismissed.

Cases cited in Judgment:

The application of the CPA

Wilkes v DePuy International Ltd [2016] EWHC 3096 (QB); [2018] QB 627
The DePuy Pinnacle Metal on Metal Hip Litigation [2018] EWHC 1208 (QB)
W v Sanofi Pasteur MSD SNC (Case C-621/15) [2017] 4 WLR 171

The Principle of effectiveness in EU Law

Sanofi Pasteur, para 26; Amministrazione delle Finanze dello Stato v SpA San Giorgio (Case C-199/82) [1983] ECR 3595

The Objective of Consumer Protection under the Directive

Boston Scientific Medizintechnik GmbH v AOK Sachsen-Anhalt – Die Gesundheitskasse (Joined Cases C-503/13 and C-504/13) [2015] 3 CMLR 6