Hastings v Finsbury Orthopaedics Ltd and another (Scotland)

Under the Consumer Protection Act 1987, a product is defective when it fails to meet the objective level of safety which persons generally are entitled to expect, taking all relevant circumstances into account. The assessment concerns the product at the time of supply, without hindsight as to expected risks. The court may nevertheless consider subsequently available evidence when deciding whether the product met that standard.

The consumer bears the burden of proving the defect and causation. Professional concern, regulatory notices and product withdrawal may constitute prima facie evidence, but are not determinative. Their evidential force must be assessed against reliable evidence available at trial. An appellate court may not disturb the resulting factual findings unless the judge erred in law, lacked an evidential basis, materially misunderstood relevant evidence or was plainly wrong.

The appellant received a metal-on-metal total hip replacement manufactured from components supplied by the respondents. Following revision surgery, he sought damages under section 2 of the Consumer Protection Act 1987, alleging that the implant was defective within section 3.

After a preliminary proof, the Lord Ordinary held that the appellant had not proved that the implant failed to meet the level of safety which persons generally were entitled to expect. The First Division of the Inner House refused the reclaiming motion in [2021] CSIH 6.

The appeal concerned whether professional concerns, regulatory notices and the product's withdrawal established a prima facie case of defect which remained sufficient despite expert statistical evidence undermining the data on which those matters depended. It also raised the limits of appellate interference with the Lord Ordinary's factual findings.

1. Appeal dismissed. Lord Lloyd-Jones delivered the unanimous judgment, with which Lord Reed, Lord Kitchin, Lord Stephens and Lady Rose agreed. The appellant had failed to prove that the implant was defective within section 3 of the Consumer Protection Act 1987.

2. The statutory test is objective. A defect exists where a product does not provide the safety which persons generally are entitled to expect, taking all factually and legally relevant circumstances into account. Entitled expectation is assessed at the time of supply and without hindsight. When determining whether that expectation was met, however, the court may and must consider relevant material available at trial, including information which emerged after supply.

3. An implant of this kind could not be expected to provide absolute safety. Its natural propensity to wear and shed potentially harmful metal debris did not itself establish a defect. The agreed measure was whether its safety was materially worse, principally by reference to time to revision, than the non-metal-on-metal products which would otherwise have been used.

4. Professional concern about metal-on-metal implants generally did not prove that this particular product was defective. Revision rates varied substantially between products. The withdrawal of the implant also supported no adverse inference because the Lord Ordinary was entitled to find that commercial considerations caused its withdrawal.

5. The regulatory and manufacturer notices initially provided powerful prima facie evidence. They depended, however, on an apparently high four-year revision rate. Unchallenged expert evidence showed that the raw registry figures were affected by outlier surgeons, differences in patient populations, confounding factors and a lowered clinical threshold for revision. That evidence contradicted rather than merely failed to confirm the factual foundation of the notices.

6. The consumer bears the burden of proving defect and causation. The Lord Ordinary was entitled to conclude on the balance of probabilities that the appellant had not discharged that burden. His findings had an evidential basis and were reasonably explained. They were not affected by an error of law or a material misunderstanding of the evidence and were not plainly wrong. There was consequently no scope to invoke EU effectiveness, enhanced consumer protection or domestic fairness to alter the result.

1. United Kingdom Supreme Court: Dismissed the appeal and affirmed the Inner House's refusal of the reclaiming motion: [2022] UKSC 19.
2. First Division of the Inner House of the Court of Session: Refused the appellant's reclaiming motion, holding that the Lord Ordinary was entitled to find that the appellant had not proved a defect: [2021] CSIH 6.
3. Outer House of the Court of Session: Following a preliminary proof, the Lord Ordinary held that the appellant had failed to prove that the product was defective. No citation is stated in the judgment.