The Supreme Court of UK holds that the nature of the prosthetic hip is such that there can be no entitlement to an absolute level of safety hence it is natural for a prosthesis to wear and to shed metal debris that can cause soft tissue damage, so that of itself cannot be a defect
August 4, 2022
Hastings v Finsbury Orthopaedics Ltd and another Supreme Court of the United Kingdom  UKSC 19 Lord Reed, President & SCJ; Lord Kitchin, Lord Stephens, Lady Rose and Lord Lloyd-Jones, SCJJ June 29, 2022 Reported by Faith Wanjiku and Bonface Nyamweya
Constitutional Law - consumer rights- physical well-being and property of the consumer- protection of the physical well-being and property of the consumer- producer’s liability for damage caused by a defect in his product- where the appellant underwent a metal-on-metal total hip replacement and later a revision of the hip implant in his left hip- where the appellant claimed that the replacement hip used in 2009 was defective and sought damages under section 2 of the Consumer Protection Act, 1987- whether certain propensities and risks inherent in the metal-on-metal prosthetic hips rendered the particular combination of components used in the appellant’s operation defective within the meaning of section 3 of the Consumer Protection Act, 1987 that defined the term defect- Consumer Protection Act, 1987, sections 2, 3, and 4; Directive of the Council of the European Communities, 1985, No 85/374/EEC, preamble, articles 1, 4, 6 and 7.
Constitutional Law- consumer rights- physical well-being and property of the consumer- protection of the physical well-being and property of the consumer- producer’s liability for damage caused by a defect in his product- where the appellant underwent a metal-on-metal total hip replacement and later a revision of the hip implant in his left hip- where the appellant claimed that the replacement hip used in 2009 was defective and sought damages under section 2 of the Consumer Protection Act, 1987- whether subject to de minimis considerations, the level of safety of the MITCH-Accolade product would not be worse, when measured by appropriate criteria, than existing non- metal-on-metal products that would otherwise have been used- Consumer Protection Act, 1987, sections 2, 3, and 4; Directive of the Council of the European Communities, 1985, No 85/374/EEC, preamble, articles 1, 4, 6 and 7.
In 2009, the appellant underwent a metal-on-metal total hip replacement. The prosthetic hip used (the MITCH–Accolade product) was manufactured by the respondents, each making separate parts. In 2012, the appellant underwent revision of the hip implant in his left hip. The appellant claimed that the replacement hip used in 2009 was defective and sought damages under section 2 of the Consumer Protection Act, 1987. The Outer House held after a preliminary proof that the appellant had failed to prove that the particular product was defective. The Inner House refused the appellant’s reclaiming motion. The appellant appealed against the First Division’s decision refusing the reclaiming motion.
- Whether certain propensities and risks inherent in the metal-on-metal prosthetic hips rendered the particular combination of components used in the appellant’s operation defective within the meaning of section 3 of the Consumer Protection Act, 1987 that defined the term defect.
- Whether, subject to de minimis considerations, the level of safety of the MITCH-Accolade product would not be worse, when measured by appropriate criteria, than existing non- metal-on-metal products that would otherwise have been used.
Relevant provisions of law Directive of the Council of the European Communities, 1985, No 85/374/EEC Preamble Whereas approximation of the laws of the member states concerning the liability of the producer for damage caused by the defectiveness of his products is necessary because the existing divergences may distort competition and affect the movement of goods within the common market and entail a differing degree of protection of the consumer against damage caused by a defective product to his health or property; Whereas liability without fault on the part of the producer is the sole means of adequately solving the problem, peculiar to our age of increasing technicality, of a fair apportionment of the risks inherent in modern technological production; Whereas, to protect the physical well-being and property of the consumer, the defectiveness of the product should be determined by reference not to its fitness for use but to the lack of the safety which the public at large is entitled to expect; whereas the safety is assessed by excluding any misuse of the product not reasonable under the circumstances; Whereas a fair apportionment of risk between the injured person and the producer implies that the producer should be able to free himself from liability if he furnishes proof as to the existence of certain exonerating circumstances;
Article 1 The producer shall be liable for damage caused by a defect in his product.
Article 4 The injured person shall be required to prove the damage, the defect and the causal relationship between defect and damage.
Article 6.1 A product is defective when it does not provide the safety which a person is entitled to expect, taking all circumstances into account, including: (a) the presentation of the product; (b) the use to which it could reasonably be expected that the product would be put; (c) the time when the product was put into circulation.
Article 7- statutory defences (e) [The producer to prove that] the state of scientific and technical knowledge at the time when he put the product into circulation was not such as to enable the existence of the defect to be discovered;
Consumer Protection Act, 1987 Section 3 (1) Subject to the following provisions of this section, there is a defect in a product for the purposes of this Part if the safety of the product is not such as persons generally are entitled to expect; and for those purposes ‘safety’, in relation to a product, shall include safety with respect to products comprised in that product and safety in the context of risks of damage to property, as well as in the context of risks of death or personal injury. (2) In determining for the purposes of subsection (1) above what persons generally are entitled to expect in relation to a product all the circumstances shall be taken into account, including –
(a) the manner in which, and purposes for which, the product has been marketed, its get-up, the use of any mark in relation to the product and any instructions for, or warnings with respect to, doing or refraining from doing anything with or in relation to the product; (b) what might reasonably be expected to be done with or in relation to the product; and (c) the time when the product was supplied by its producer to another; and nothing in this section shall require a defect to be inferred from the fact alone that the safety of a product which is supplied after that time is greater than the safety of the product in question.
- The nature of the MITCH–Accolade product was such that there could be no entitlement to an absolute level of safety. It was natural for a prosthesis to wear and to shed metal debris that could cause soft tissue damage, so that of itself could not be a defect. The test of entitled expectation was agreed by the parties and held by the Outer House to be whether, subject to de minimis considerations, the level of safety of the MITCH-Accolade product would not be worse, when measured by appropriate criteria, than existing nonmetal-on-metal products that would otherwise have been used.
- The Outer House adopted two criteria of entitled expectation. First, it adopted the time to revision which was considered by the expert witnesses to be a very important measure of implant performance. Secondly, it considered that it should also have regard to the prospects of success of revision surgery as a relevant consideration in assessing whether there was a failure to meet entitled expectation. With regard to the second criterion, the Outer House concluded that the appellant had not proved that metal debris from metal-on-metal total hip replacement created a risk that revision surgery would be less likely to lead to a satisfactory outcome than with other prostheses. On appeal, therefore, the sole criterionof entitled expectation had been time to revision.
- The Outer House observed that any finding had to be based upon evidence relating directly or by necessary implication to the MITCH-Accolade product. He noted that of the expert witnesses Professor Pandit (the respondents’ orthopaedic expert) had never used the product, Professor Breusch (the appellant’s orthopaedic expert) had never implanted any metal-on-metal device and Dr McCarthy (the respondents’ histopathology expert) was also unfamiliar with that kind of metal-on-metal total hip replacement. Furthermore, he had not been referred to any article specific to the MITCH-Accolade product and it had not been suggested that any such article existed. As a result, he considered that it was necessary to make what he could of published data in relation to the product, properly interpreted. In his view, the evidence of Professor Platt was accordingly of importance.
- The Outer House referred to the National Institute for Health and Clinical Excellence benchmark that the best prostheses demonstrated a revision rate of 10% or less at ten years and to the UK Orthopaedic Data Evaluation Panel criteria for categorising a total hip replacement product as Class A in relation to the National Institute for Health and Clinical Excellence benchmark revision rates of 3% at three years, 5% at five years, 7% at seven years and 10% at ten years, subject to a 95% confidence interval. The Outer House noted that the Medical Device Alert issued in April 2012 in relation to the MITCH-Accolade product referred to a revision rate of 10.7% at four years based on 271 patients recorded by the UK National Joint Registry.
- Professor Platt provided an analysis based on the UK National Joint Registry supplier feedback data of the cumulative revision probability of the MITCH-Accolade product, disclosing a figure of 23.2% (95% confidence interval 18.4%, 28.9%) at ten years. The figure for four years in the same table was 10.5% (95% CI 7.3%, 14.8%). The Outer House observed that, so far as they went, the data from 2012 which informed the Medicines and Healthcare Products Regulatory Agency alert and the (latest available) data from 2018 were consistent in showing, prima facie, a revision rate for metal-on-metal total hip replacements were significantly worse than rates for available alternatives.
- 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 metal-on-metal prostheses. The Outer House referred in its judgment to one of the first papers, published in July 2008 by a team at the Nuffield Orthopaedic Centre, Oxford, which reported an incidence of soft-tissue mass, described as a pseudotumour, in a group of patients experiencing problems after metal-on-metal hip resurfacing, as opposed to total hip replacement. The estimated incidence was approximately 1% of metal-on-metal resurfacing patients at five years. Further investigation was recommended. The Outer House noted that those observations were initially greeted with surprise and scepticism by the orthopaedic community.
- In 2009 the Nuffield team published a further paper reporting that revision surgery in a group of metal-on-metal resurfacing patients with symptomatic pseudotumours had a poor outcome because of the associated soft tissue destruction. A third paper by the Nuffield team described necrosis and inflammation in periprosthetic soft tissues in failed second generation metal-on-metal resurfacing arthroplasties, in response to the deposition of cobalt chromium wear particles.
- Adverse reaction to metal debris was first reported at a national orthopaedic conference in 2008-2009 and awareness of it increased during the next two to five years as a consequence of the publication of scientific papers in peer reviewed journals. An expert committee set up by the Medicines and Healthcare Products Regulatory Agency in April 2010 further developed awareness among clinicians, patients and others. The Outer House also noted that public concern regarding the safety of metal-on-metal implants was increased by the broadcasting of the results of an investigation by the British Medical Journal and BBC Newsnight.
- That evidence and those expressions of concern related, however, to the performance of metal-on-metal prostheses in general. It was not in dispute that the reported revision rates of metal-on-metal prostheses varied from product to product. The Outer House noted that there was a huge variation in the reported revision rates amongst different brands of metal-on-metal Hips. The Outer House was at pains to emphasise that the proof was concerned only with the MITCH-Accolade prosthesis and did not seek to review metal-on-metal prostheses as an entire class or to analyse the performance of other metal-on-metal prostheses. Given the wide range of revision rates in the case of metal-on-metal prostheses generally and the fact that the revision rates for metal-on-metal prostheses were typically higher than those for non- metal-on-metal prostheses, the generalised expressions of professional concern did not assist the appellant in establishing that the MITCH-Accolade product was defective.
- On behalf of the appellant, it was submitted that the respondents’ calculated action in withdrawing the product from the market prevented the appellant from proving his case by reference to statistical analysis. To the extent that it could be suggested that that was a deliberate tactic on the part of the respondents, it lacked any foundation. Contrary to the submission on behalf of the appellant, it was not open to the court to draw an adverse inference from the decision of the respondents to withdraw the MITCH-Accolade product.
- The Outer House made findings as to the reasons for the withdrawal of the product. The Outer House found that the product became commercially available in the United Kingdom in 2006. Its level of sales was never high in comparison with rival products. Sales figures for the MITCH-Accolade product showed that 973 were sold in 2008, 468 in 2009, 212 in 2010, and 29 in 2011. It had been suggested in evidence that that was due to the fact that the second respondent had come late to the market, after other products had become well established. The Outer House found that after the 1st respondent was acquired by DePuy International Ltd (DePuy) in 2009, it continued for a time to perform its contractual obligations to the 2nd respondent.
- The supply agreement was due to terminate in 2011 and was not renewed. There was evidence that that was because DePuy had no desire to renew an agreement to manufacture and supply a product to a commercial competitor. The Outer House accepted that that was part of the reason why the manufacture and supply of the MITCH-Accolade product ceased in about 2011 but considered that the predominant consideration was that sales of metal-on-metal total hip replacements generally had sharply declined by the end of the decade.
- The product was withdrawn from the market in 2011 and that was before any Medical Device Alert was issued in relation to the MITCH-Accolade product specifically, as opposed to metal-on-metal prostheses generally. The Medical Device Alert relating to the MITCH-Accolade product specifically was issued on April 2, 2012 and the urgent Field Safety Notice was issued by DePuy and the 2nd respondent on April 26, 2012. A Field Safety Notice was a communication from the manufacturer identifying that a product could not be performing as intended by the manufacturer and explaining the actions to be taken by customers to reduce the specified risks. The withdrawal of the MITCH-Accolade 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 first Medical Device Alert in relation to metal-on-metal hip replacements was issued by the Medicines and Healthcare Products Regulatory Agency in April 2010. Under the heading: Problem it stated that the majority of patients implanted with metal-on-metal hip replacements had well-functioning hips and were thought to be at a low risk of developing serious problems. However, it stated that a small number of patients implanted with those hips could, however, develop progressive soft tissue reactions to the wear debris associated with metal-on-metal articulations. The debris could cause soft tissue necrosis and adversely affect the results of revision surgery. The Medical Device Alert further stated that early revision of poorly performing metal-on-metal hip replacements should give a better revision outcome. The action required of orthopaedic professionals by the Medical Device Alert was to put systems in place for the follow-up of patients implanted with metal-on-metal hip replacements including, where appropriate, blood metal ion measurements and cross sectional imaging.
- Revised Medical Device Alerts were issued on April 2, 2012 (for the MITCH-Accolade product in particular) and on June 25, 2012 (for all metal-on-metal hip replacements). The problem identified by the April Medical Device Alert was the same. The action required in the June Medical Device Alert differed depending upon whether the hip replacement had been a resurfacing, a total hip replacement with an acetabular head diameter of less than 36 mm, or a total hip replacement with a head diameter page 21 of 36 mm or more. Within the latter category, the action required depended upon whether or not the patient was symptomatic, but one recommendation common to both symptomatic and asymptomatic patients was for an annual follow-up for the life of the implant.
- On April 26, 2012 an urgent Field Safety Notice was issued by DePuy and the 2nd respondent regarding the product. The problem identified was that review of post-market surveillance data suggested a higher than expected revision rate for the product. The action to be taken was not to implant the MITCH-Accolade product.
- As matters stood in 2012 it was clearly necessary for the Medicines and Healthcare Products Regulatory Agency and the respondents to issue those notices. In the case of the respondents, it was also a page 25 commercially prudent step to issue the Field Safety Notice, notwithstanding the fact that the MITCH-Accolade product was no longer being marketed. However, those notices and statistics could not of themselves be determinative of the issue whether there was a breach of an 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 at the time of proof which was not available in 2012 when the notices were issued. By the time of proof in 2019 there was in evidence before the Outer House a statistical analysis by Professor Platt which was not contested by the appellant. The prima facie evidence provided by the notices had to be examined in the light of such of the conclusions of Professor Platt as were accepted by the Outer House.
- The reasoning which led Professor Platt to the conclusion that the appellant’s case of a breach of entitled expectation was not made out on a statistical basis, applied equally to that category of prima facie evidence. Contrary to the submission on behalf of the appellant, the Outer House’s conclusions on the statistical evidence were not neutral. They contradicted the appellant’s case founded on statistics and, for the same reasons, contradicted the information then available which formed the basis of the concerns, alerts and safety notices in the years 2010 to 2013. Professor Platt’s evidence did not leave that category of prima facie evidence unchallenged; on the contrary it undermined it.
- In order to reverse a determination of fact, the appellate court had to be satisfied that the Outer House erred in law, made a finding without any basis in the evidence or demonstrably misunderstood, or failed to consider, relevant evidence. Otherwise, it could only interfere with the findings of fact if it concluded that the Outer House was plainly wrong, in the sense of his decision not being capable of being reasonably explained or justified. None of those requirements was satisfied in the present case and, accordingly, it was not open to the court to interfere with the Outer House’s findings. In those circumstances, there was no scope for the application of the principle of effectiveness in EU law, any principle of EU law which might require greater weight to be attached to considerations of consumer protection, or any domestic law principle of fairness which might require a benevolent application of the Consumer Protection Act, 1987.
Relevance to the Kenyan jurisprudence
Article 46 of the Constitution of Kenya, 2010, enunciates the consumers’ rights when it states that:
1. Consumers have the right-
a. to goods and services of reasonable quality; b. to the information necessary for them to gain full benefit from goods and services; c. to the protection of their health, safety, and economic interests; and d. to compensation for loss or injury arising from defects in goods or services.
2. Parliament shall enact legislation to provide for consumer protection and for fair, honest and decent advertising. 3. This Article applies to goods and services offered by public entities or private persons.
The Consumer Protection Act 46 of 2012 in section 5 explicates on the quality of goods and services when it notes that:
(1) The supplier is deemed to warrant that the goods or services supplied under a consumer agreement are of a reasonably merchantable quality. (2) The implied conditions and warranties applying to the sale of goods under the Sale of Goods Act (Cap. 31) shall apply with necessary modifications to goods that are leased, traded or otherwise supplied under a consumer agreement. (3) Any provision, whether part of the consumer agreement or not, that purports to negate or vary any implied condition or warranty under the Sale of Goods Act (Cap. 31) or any condition or warranty under this Act is void. (4) If a term or acknowledgement referenced in subsection (3) is a term of the agreement, it is severable from the agreement and shall not be evidence of circumstances showing intent that the deemed or implied warranty or condition does not apply.
The High Court in Simon Mwangi Ndung’u & another v Director of Criminal Investigations & 5 others  eKLR noted that consumers who deal with goods and services have a right to protection of their health, safety and even economic interest.
This case is therefore instrumental in Kenya’s jurisprudence as it illuminates on the instance where there can be no consumer’s entitlement to an absolute level of safety in using a product.