Mr Hastings claimed his metal-on-metal hip prosthesis (MITCH-Accolade product) was defective under the Consumer Protection Act 1987. The Supreme Court upheld lower court findings that he failed to prove, on the balance of probabilities, that the product’s safety fell below entitled expectations, as statistical evidence undermined his prima facie case.
Background
In 2009, the appellant, Mr John Hastings, underwent a metal-on-metal (MoM) total hip replacement using the MITCH-Accolade product, manufactured by the respondents Finsbury Orthopaedics Ltd and Stryker UK Ltd. In 2012, Mr Hastings required revision surgery. He brought a claim under section 2 of the Consumer Protection Act 1987 (‘CPA’), alleging the prosthesis was defective within the meaning of section 3 of the CPA. The issues at first instance were limited to whether certain propensities and risks inherent in MoM prosthetic hips rendered the MITCH-Accolade product defective. The Lord Ordinary (Lord Tyre) in the Outer House held, after a preliminary proof, that the appellant had failed to prove that the product was defective. The Inner House refused the appellant’s reclaiming motion. The appellant appealed to the UK Supreme Court.
The Issue(s)
The central question was whether the Lord Ordinary was entitled, after a full consideration of the evidence, to conclude that notwithstanding certain prima facie evidence of defectiveness — namely expressions of serious professional concern in the orthopaedic community, withdrawal of the product from the market by the respondents, and notices and alerts issued by regulators and manufacturers — the appellant had nonetheless failed to discharge the burden of proving that the MITCH-Accolade product did not meet the standard of safety that persons generally were entitled to expect.
The test of ‘defect’
The parties agreed the applicable legal principles. The test under section 3 CPA (implementing Article 6 of the Product Liability Directive 85/374/EEC) is whether the safety of the product is not such as persons generally are entitled to expect, assessed objectively having regard to all the circumstances. The entitled expectation was agreed to be whether, subject to de minimis considerations, the level of safety of the MITCH-Accolade product was not worse, when measured by appropriate criteria, than existing non-MoM products that would otherwise have been used. The sole remaining criterion of entitled expectation on appeal was ‘time to revision’ (survivorship of the implant).
The Parties’ Arguments
The appellant’s case
The appellant submitted that despite the statistical evidence of Professor Platt, his prima facie case was maintained by the response of the orthopaedic community, the national regulator, and the respondents themselves in withdrawing the product. He argued that Professor Platt’s evidence was neutral because no reliable statistical assessment of long-term survivorship could be made, and that the most plausible explanation for the failure of his prosthesis was that the product was defective. He invoked the EU principle of effectiveness, submitting that requiring proof by statistics rendered it excessively difficult for him to exercise rights under the Directive. He also relied on the objective of consumer protection under the Directive and argued that a benevolent application of the CPA was warranted because the respondents’ actions in withdrawing the product had deprived him of the data needed to prove his case statistically.
The respondents’ case
The respondents relied on the unchallenged evidence of Professor Robert Platt, Professor of Pharmacoepidemiology at McGill University, who demonstrated that available statistical data did not reliably establish that the MITCH-Accolade product’s revision rate was out of line with relevant benchmarks. The respondents accepted that the notices appeared on their face to provide powerful evidence, but submitted that their basis — NJR revision statistics — was unreliable due to confounding factors, outlier surgeons, small sample sizes, and a lowered threshold for revision caused by publicity rather than the product’s performance.
The Court’s Reasoning
Professional concern
Lord Lloyd-Jones, delivering the unanimous judgment, noted that the expressions of professional concern related to MoM prostheses in general, not the MITCH-Accolade product specifically. Given the wide range of revision rates among different MoM products, these generalised expressions of concern did not assist the appellant in establishing that the specific product at issue was defective.
Withdrawal from the market
The Court found no basis for drawing an adverse inference from the respondents’ decision to withdraw the product. The Lord Ordinary made findings that the withdrawal was principally due to commercial factors: DePuy’s acquisition of Finsbury and non-renewal of the supply agreement with Stryker, combined with the general sharp decline in MoM THR sales. Critically, the product was withdrawn in 2011, before any Medical Device Alert was issued specifically in relation to the MITCH-Accolade product.
Notices and alerts
While acknowledging that the MDA and FSN issued in April 2012 appeared on their face to support the appellant’s case, the Court held these could not be determinative. The basis for the notices was the NJR statistic of a 10.7% revision rate at four years. However, Professor Platt’s analysis, substantially accepted by the Lord Ordinary, demonstrated that this figure was unreliable for multiple reasons: confounding factors including patient demographics (younger, more active, predominantly male patients), outlier surgeons, small sample sizes, and a lowered threshold for revision surgery driven by publicity rather than product performance. Lord Lloyd-Jones stated:
Contrary to the submission on behalf of the appellant, the Lord Ordinary’s conclusions on the statistical evidence are not neutral. They contradict the appellant’s case founded on statistics and, for the same reasons, contradict 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 does not leave this category of prima facie evidence unchallenged; on the contrary it undermines it.
The Lord Ordinary had found that when the two identified outlier surgeons were excluded, the ten-year cumulative revision probability fell from 23.2% to 14.3% (95% CI 9.8-20.7%), meaning the product met NICE guidance under ODEP’s methodology. The confounding factors — particularly that the product was implanted in younger, more active, predominantly male patients — were likely to have lowered average survivorship for reasons unconnected with the implant itself. Additionally, the lowered threshold for revision surgery driven by media coverage and generalised MoM concerns had likely inflated revision rates.
Standard of review and burden of proof
Lord Lloyd-Jones endorsed the Lord President’s observation that:
in order to reverse a determination of fact, the appellate court must be satisfied that the Lord Ordinary erred in law, made a finding without any basis in the evidence or demonstrably misunderstood, or failed to consider, relevant evidence. Otherwise, it can only interfere with the findings of fact if it concluded that the Lord Ordinary was plainly wrong, in the sense of his decision not being capable of being reasonably explained or justified.
The Court found that none of these requirements was satisfied. Lord Lloyd-Jones stated:
Ultimately, this appeal is no more than an attempt to appeal against the Lord Ordinary’s findings of fact.
EU law and fairness arguments
The Court held that because the appellant simply failed to discharge the burden of proof on the facts, there was no scope for applying the EU principle of effectiveness, any EU principle requiring greater weight for consumer protection, or any domestic principle of fairness requiring a benevolent application of the CPA.
Practical Significance
This decision confirms that prima facie evidence of product defectiveness — including regulatory alerts, professional concern and product withdrawal — can be rebutted by expert statistical evidence demonstrating that the underlying data was unreliable or subject to confounding factors. It affirms that the court, in assessing whether a product meets the standard of entitled expectation under the CPA, is entitled to consider material available at the time of proof, including evidence that post-dates the alerts and concerns relied upon by the claimant. The case underscores the importance of the distinction between generalised concerns about a class of products and specific evidence relating to the particular product in question. It also confirms that the burden of proving defect remains on the consumer, and that the EU principle of effectiveness does not lower the standard of proof or require courts to accept prima facie evidence where it has been undermined by unchallenged expert analysis.
Verdict: The appeal was dismissed. The Supreme Court unanimously upheld the decisions of the Outer House and Inner House, holding that the appellant had failed to prove on the balance of probabilities that the MITCH-Accolade product was defective within the meaning of section 3 of the Consumer Protection Act 1987.
Source: Hastings v Finsbury Orthopaedics Ltd and another [2022] UKSC 19
