(Hastings (Appellant) v Finsbury Orthopaedics Ltd and another (Respondents) (Scotland)  UKSC 19)
The appellant in the case of Hastings (Appellant) v Finsbury Orthopaedics Ltd and another (Respondents) (Scotland)  UKSC 19, has failed to demonstrate to the UK Supreme Court (UKSC) that a prosthetic hip (manufactured by the respondents, each making separate parts) used in a metal-on-metal hip replacement was defective. Rather, the UKSC unanimously upheld the finding of the lower courts and concluded that the nature of the product meant that there could be no entitlement to an absolute level of safety.
The judgment is likely to be welcomed by those involved in the manufacture and distribution of medical devices and other health care products, as it continues the pragmatic approach of the UK courts in seeking to balance the need to achieve a high level of consumer protection against a robust assessment of the standards which the public can realistically expect manufacturers to achieve.
The appellant in the case, Mr. Hastings, underwent a metal-on-metal total hip replacement, implanting a prosthetic hip, the MITCH-Accolade, manufactured by the Respondents (“Product“). Mr. Hastings claimed damages on the basis that the Product was defective under the Consumer Protection Act 1987 (CPA).
Mr. Hastings’ case rested on two main bases; first that the Product was defective due to design flaws, and second that there existed prima facie evidence that the Product was defective. Despite being previously unsuccessful at first instance and on appeal, Mr. Hastings brought an appeal against the decisions of the lower courts, seemingly to reverse a determination of fact (i.e., regarding the evidence allegedly supporting a finding of defect), but ultimately failed to prove to the UKSC that it should interfere with the views of the lower courts, or that a different decision regarding the alleged “defect” should be reached.
Some key points made in the judgment (available here) are set out below.
- The UKSC confirmed that the nature of the Product is such that there can be no entitlement to an absolute level of safety. Giving a nod to Gee & Others v DePuy International Limited  EWHC 1208, the UKSC noted that despite the fact that a prosthesis (such as the Product) does wear and shed metal debris that can cause soft tissue damage, this was a natural occurrence and therefore cannot in and of itself constitute a “defect“.
- The test of whether a product is defective (i.e., whether the safety of the Product is not such as persons are generally entitled to expect) is an objective one and is a test of “entitled expectation” rather than what is expected. In the circumstances, the parties and the lower Court agreed that the test of entitled expectation was whether the level of safety of the Product would not be worse, when measured by appropriate criteria, than existing non–metal-on-metal products that would otherwise have been used.
- Mr. Hastings failed to establish his case on a statistical basis (for example, taking into account expert evidence submitted by the Respondents, which analysed revision rate statistics). The question for the appeal was whether the lower Court’s rejection of the statistical evidence nevertheless left prima facie evidence that Mr. Hastings could rely on to prove his case. The UKSC concluded that it did not.
- In response to Mr. Hastings’ argument that professional concerns about the performance of metal-on-metal prostheses generally were prima facie evidence of a defect, the UKSC maintained that the wide range of revision rates with metal-on-metal prostheses generally (and particularly as compared to non-metal-on-metal prostheses) meant generalised expressions of professional concern did not assist Mr. Hastings in establishing that the Product was defective.
- The UKSC accepted it as correct that the circumstances and reasons for the withdrawal of the Product (in this case brought about by commercial considerations) did not provide any support for Mr. Hastings’ case that the Product was defective. In response to Mr. Hastings’ assertion that the withdrawal from the market prevented him from proving his case using statistical evidence, the UKSC held that a suggestion that this was a deliberate tactic lacked any foundation. The UKSC also held that it was not open to the Court to draw an adverse inference from the decision to withdraw the Product.
- The UKSC decided that the fact that a medical device alert and field safety notice were later issued was also not prima facie evidence of a defect. The UKSC considered those notices in light of later evidence (such as the expert evidence referred to above).
- The judgment reinforces previous case law to the effect that the Court will be reluctant to make a finding of defect based purely on product failure/consumer dissatisfaction, or because of a voluntary product withdrawal, and so will provide some comfort to manufacturers faced with difficult post-marketing decisions.