25 July 2022
The UK Supreme Court has for the first time examined the statutory concept of a "defective product" under the strict product liability regime in the Consumer Protection Act 1987 (CPA). This consideration by the highest court authority took place in the judgment of Hastings v Finsbury Orthopaedics Ltd  UKSC 19, the latest in the series of claims arising out of metal-on-metal (MoM) hip prostheses.
The Supreme Court upheld the lower courts' findings that Mr Hastings (the Appellant) had failed to prove that the Mitch-Accolade hip replacement (MITCH-Accolade HR) was defective under the CPA. This is a welcome decision for manufacturers, as it indicates that the courts will refuse to look at raw evidence put forward by a claimant in isolation, and will instead place it within the wider picture.
It also serves as a helpful reminder of the statutory test for establishing a "defect" under the CPA which has been endorsed by the Supreme Court and confirms the tests set out in the seminal decisions of Wilkes/Gee v DePuy. It is now clear that the relevant expectation applied by Andrews J in Gee stands for medical devices such that there can be no entitlement to a complete level of safety and where there is a propensity of risk (such as the shedding of metal debris from wear of a prosthesis that can cause soft tissue damage) that is not determinative of a defect. Similarly, a product recall will not automatically give rise to evidence of a defect. This will be very helpful to manufacturers when carrying out a risk assessment following a suspected safety incident and balancing the need for corrective action against the risk of follow on claims.
The Supreme Court confirmed the objective test employed by the High Court with respect to the concept of "defect" by Wilkes v DePuy International Ltd  EWHC 3096 (QB) and Gee v DePuy International Ltd  EWHC 1208 (QB), and also the CJEU in W v Sanofi Pasteur MSD SNC (Case C-621/15).
In summary, a product is defective under the CPA when, in all the circumstances, it fails to meet the standard of safety that the public at large is generally entitled to expect at the time when it is introduced to the market. In this context, "safety" is considered with regard to the risk of death or personal injury, as well as damage to property. The court may consider a number of factors in respect of the level of safety, including the purpose of the product, instructions for use and warnings, presentation of the product, expected use and time when it was put into circulation.
The CPA creates liability without fault. This means that it is irrelevant whether the manufacturer is at fault or not, and the claimant need only prove that:
This is a welcome judgment for manufacturers of both medical devices and products more generally. The Court refrained from applying the provisions of the CPA in a benevolent manner, which showcases the required balance between the need to encourage innovation, and the need to protect consumers.
In taking this approach, the Supreme Court rejected the Appellant's argument that the evidence he put forward gave rise to a non-rebuttable presumption of a defect.Importance of factual context: statistical data and withdrawal from the market
The Supreme Court warned against taking statistical evidence at face value. In isolation, the numbers that the Appellant put forward indicated that the probability of a MITCH-Accolate HR requiring revision surgery was significantly higher than for other similar hip replacement products. The Court however emphasised the importance of challenging and qualifying statistical data with regard to its factual context. The Court thus approached this data through a wider lens than the raw numbers themselves, and took into consideration the lowered threshold for revision surgery due to widespread media coverage and clinicians' fears of further complications developing, as well as the typical recipient of a Mitch-Accolate HR being young and active.
Similarly, the Court rejected that an adverse inference could be drawn from the manufacturers' action of withdrawing the MITCH-Accolade HR from the market. Both the timing of the withdrawal, and the other commercial considerations at play, were analysed. The declining sales of the MITCH-Accolade HR, coupled with the fact that it was withdrawn before the Medical Device Alert (MDA) and urgent Field Safety Notice (FSN) were issued, led the Court to conclude that withdrawing the MITCH-Accolade HR was not determinative of it being defective.
Product-specific evidence required
The Court refused to place any weight on evidence of failing MoM prostheses generally, and instead highlighted that the only evidence of use was that concerning the MITCH-Accolade HR product specifically.
The Court disregarded the evidence that had been put forward by the experts, who, while familiar with MoM prostheses in general, had not used the MITCH-Accolade HR in their practice. Similarly, the timing of the MDA for MoM prosthesis generally was seen as irrelevant: only the MDA for the MITCH-Accolade HR specifically was seen to be useful by the Court.
Product recall not determinative of a defect
The Court did not accept the Appellant's argument that the Respondent's act of withdrawing the MITCH-Accolade HR from the market was determinative of the product being defective. The Court refused to draw an adverse inference from the Respondent's voluntary decision to withdraw, and instead found that the withdrawal was driven by commercial considerations, in particular the lack of business sense in renewing a supply agreement when sales were sharply declining.
Please contact our product liability and safety team for further information.