The first Supreme Court product liability decision: Hastings v. Finsbury Orthopaedics
On Wednesday 29th June 2022, the Supreme Court handed down its judgement in the Scottish case of Hastings (Appellant) v Finsbury Orthopaedics Ltd and another (Respondent), unanimously dismissing the appeal. Hastings follows in a long line of cases in which UK claimants have failed to prove “defect” under s.2 of the CPA, albeit, until now all of those decisions remained at first instance.
Background
The appellant was implanted in 2009 with an allegedly defective hip manufactured by co-Defendant medical device manufacturers, Stryker and Finsbury Orthopaedics. The Claimant alleged that the metal-on-metal hip was defective with reference to s.2 of the Consumer Protection Act 1987.
At first instance, the “Outer House” in Scotland held that the Claimant had failed to prove that the device with which he was implanted was defective. The Claimant proceeded to apply for permission to appeal to the “Inner House”. This was refused, such that the matter was appealed to the Supreme Court.
By the time the claim reached the Supreme Court, the appellant’s case had been considerably narrowed: he had originally contended that the device was defective with reference to [17]:
- design flaws which increased the risk of patients suffering adverse reaction to metal debris in comparison with debris produced by non-metal-on-metal hip prostheses
- design flaws which led to a greater risk of early failure of the device and
- the allegedly poorer clinical outcome for patients post revision.
All three arguments had been dismissed by the lower courts, such that the question before the Supreme Court was whether the prima facie evidence of defect alone, as advanced by the appellant, could be relied upon. This prima facie evidence comprised [18]:
- professional concerns expressed about the product across the orthopaedic community [42]
- the fact of product withdrawal by the manufacturer [44] and
- regulatory interventions issued by the MHRA in the form of Medical Device Alerts and Field Safety Notices describing the elevated failure rate of the product.
The Supreme Court found that each of the prima facie grounds advanced by the appellant was insufficient to establish defect.
On the question of whether or not the product met the standard of safety that consumers are entitled to expect, the so called “entitled expectation” test, as per s.3(2) of the CPA, the parties agreed that the relevant test was whether the level of the safety of the product would be worse when measured by appropriate criteria against other non-metal-on-metal hip devices [19]. In assessing this standard, the Court determined that there were 2 “appropriate criteria”:
- time to revision and
- prospects of success of revision.
The lower Courts had found that there was no evidence in support of the second proposition, such that “entitled expectation” could only be measured with respect to the time to revision for the product [20].
Consequently, by the time the case reached the Supreme Court, epidemiology had become central to the determination of defect, and yet, as acknowledged by the Supreme Court [21] and as accepted by both parties, the available statistical data was not sufficient in itself to establish defect [16].
The appellant’s case therefore failed.
Comment
The first and only claimant-friendly decision under the CPA remains A vs National Blood which is now over 20 years old. As a result of the Supreme Court’s decision in Hastings, and the more recent decisions of Wilkes and Gee, A v NB has now been superseded.
Hastings does nothing to break the defendant’s winning streak. However, it does underscore just how difficult the claimant’s task is in proving defect, in particular, on the basis of statistical or epidemiological data. As per Hastings, such evidence is too often incomplete, subject to biases, and too limited in scope to withstand critique from bio-statistical experts, despite the fact that this data is often used to monitor product safety by manufacturers and regulators alike.
The appellant argued that by requiring him to prove his case on the basis of statistics that, in the context of his defective device, do not exist he was set an “impossible task” [40] by the lower Courts and that it had been made “excessively difficult” [38] for him to prove his case, contrary to the principle of effectiveness in EU law [38-40]. The Supreme Court remained unconvinced by these arguments concurring with the rulings of the lower Courts and ruling that there was no scope for a “benevolent application of the CPA” [65].
Takeaways from Hastings, for claimant teams still seeking to use the CPA 1987, may include:
- avoid rooting cases on defect i.e. “entitled expectation” in epidemiological evidence, wherever possible and
- being mindful that “prima facie” evidence of product failure, as wielded in Hastings, will not be sufficient in itself to evidence defect.
However, the Supreme Court’s judgment in Hastings still begs the question: what might a defective product, consistent with s.2 CPA 1987 actually look like? Remarkably, some 22 years after A v NB, THAT question still remains to be answered by the Courts of England, Wales and Scotland.
Decision Hastings v Finsbury Orthopaedics & Another
Decision A vs National Blood