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In this post, Sophie Malley, a trainee solicitor at CMS, comments on the decision in Hastings v Finsbury Orthopaedics Ltd and Anor [2022] UKSC 19, the first product liability case to reach the UK Supreme Court.

On 29 June 2022, the Supreme Court unanimously dismissed the appeal in Hastings v Finsbury Orthopaedics Ltd and Anor [2022] UKSC 19. The Supreme Court adhered to the findings of the lower courts in Scotland (previewed here) that the metal on metal prosthesis used for Mr Hastings’ total hip replacement was not defective under the Consumer Protection Act 1987 (the “CPA”), s 3. The decision, in favour of the manufacturers, was handed down approximately two months after the case was heard by the Supreme Court.

Background

Mr Hastings underwent a metal on metal total hip replacement (the “MoM THR”) in March 2009 which was revised in October 2012. The prosthesis used comprised of compatible component parts manufactured by each of the respondents (the “Mitch/Accolade product”). Mr Hastings subsequently brought a claim under the CPA, s 2 for personal injury allegedly caused as a result of the Mitch/Accolade product being defective.

Decision of the lower courts

At first instance, the Outer House of the Court of Session considered whether the inherent propensity of MoM prostheses to shed metal debris once implanted rendered the Mitch/Accolade product defective (that being less safe than persons generally are entitled to expect) under the CPA, s 3. Lord Tyre, the Lord Ordinary, clarified that in order for the Mitch/Accolade product to meet the entitled expectation, “its level of safety would not be worse, when measured by appropriate criteria, than existing non-MoM products that would otherwise have been used”. With reference to the statistical evidence presented to the court, Lord Tyre found that Mr Hastings failed to prove that the product was defective.

Mr Hastings appealed to the Inner House of the Court of Session. The Inner House noted that in order to reverse a determination of fact, it must be satisfied that the Lord Ordinary erred in law, made a finding not based on the evidence or clearly misunderstood, or disregarded, relevant evidence. As none of these requirements were met, the Inner House upheld the first instance decision.

Supreme Court decision

Mr Hastings proceeded to appeal to the Supreme Court. The legal issues concerning the application of the CPA were largely agreed between the parties. The appeal was essentially an attempt to appeal against the Lord Ordinary’s findings of fact. Mr Hastings was previously found to have failed to prove his case on a statistical basis. Therefore, the question for the Supreme Court was whether there was additional evidence Mr Hastings could use to prove that the Mitch/Accolade product did not meet the entitled expectation in terms of the CPA.

The evidence relied on by Mr Hastings comprised the response of: (1) the orthopedic community; (2) the national regulator; and (3) the manufacturers withdrawing the Mitch/Accolade product from the market. The Supreme Court addressed each category of evidence in turn.

Concerns of the orthopedic community

In July 2008, orthopedic surgeons began to express serious professional concerns about high revision rates (the percentage chance that revision surgery will be required to replace a prosthesis) and potential difficulties in performing operations in cases of MoM prostheses. This concern was, however, expressed in relation to MoM prostheses generally and as the Lord Ordinary observed, there was “huge variation in the reported revision rates amongst different brands of MoM Hips”. Taking this into account and the fact that revision rates for MoM prostheses tended to be higher than those for non-MoM prostheses, the Supreme Court held that “the generalised expressions of professional concern” did not assist Mr Hastings in establishing that the Mitch/Accolade product was defective.

Withdrawal of the Mitch/Accolade product

Mr Hastings sought to argue that the manufacturers’ withdrawal of the Mitch/Accolade product from the market was a “calculated action” which prevented him from proving his case by reference to statistical evidence. The court held that this assertion lacked foundation. This was based on the Lord Ordinary’s finding that the withdrawal of the Mitch/Accolade product was based on commercial considerations such as low sales in comparison to rival products, the failure of the manufacturers to renew their supply agreement and the sharp decline in sales of MoM prostheses by 2010. The Supreme Court found that such circumstances and reasoning for withdrawing the Mitch/Accolade product from the market did not support Mr Hastings’ case that the product was defective.

Notices issued in relation to the Mitch/Accolade product

The Medicines and Healthcare Products Regulatory Agency and the manufacturers respectively issued a Medical Device Alert and Field Safety Notice with regard to the Mitch/Accolade product in 2012 (the year after it was withdrawn from the market). These were based on statistical evidence that the revision rate for the Mitch/Accolade product was higher than anticipated, that being 10.7% at four years. This was compared with the guidance issued by the National Institute for Health and Clinical Excellence in 2000 which stated that the best prostheses had a revision rate of 10% at ten years. The manufacturers, therefore, accepted that these notices appeared to support arguments that the Mitch/Accolade product failed to meet the entitled expectation.

The Supreme Court disagreed and stated that “these notices and statistics cannot of themselves be determinative of the issue whether there was a breach of an entitled expectation”. The Supreme Court clarified that in assessing whether an entitled expectation has been met, it should “have regard to material available at the time of proof which was not available in 2012 when the notices were issued”. Therefore, the notices were considered by the Supreme Court in light of the uncontested statistical analysis presented to the Lord Ordinary by an expert witness for the defenders. This evidence was found to contradict the information forming the statistical basis of the notices and therefore undermined Mr Hastings’ ability to rely on them to demonstrate that the product was defective.

Comment

The decision of the Supreme Court confirms the Scottish Courts’ approach to the entitled expectation test. The Court ruled that “there can be no entitlement to an absolute level of safety” for MoM prostheses. This is due to the natural tendency of a MoM prosthesis to shed metal debris that can cause soft tissue damage which cannot, in itself, be classified as a defect.

This judgment will be welcomed by medical device manufacturers. The importance placed on statistical evidence throughout the history of this case highlights the uphill struggle claimants face when attempting to prove a product is defective within the terms of the CPA.