Hastings v Finsbury Orthopaedics Ltd & Anor (Scotland)

Factual and Procedural Background

The Appellant underwent a metal-on-metal total hip replacement using the “MITCH-Accolade” prosthesis in 2009. The device’s acetabular and femoral components were manufactured by the Defendants. In 2012 the Appellant required revision surgery on the same hip.

Alleging that the product was defective, the Appellant sued for damages under section 2 of the Consumer Protection Act 1987 (“CPA”). A preliminary proof in the Outer House before Judge Tyre focused solely on whether inherent risks associated with metal-on-metal hips made this particular product “defective” under section 3 CPA. Judge Tyre held that defectiveness was not established. The First Division of the Inner House (Judge Carloway, Judge Menzies and Judge Woolman) refused the Appellant’s reclaiming motion. The present appeal to the Supreme Court challenges that refusal; if successful, the Appellant sought remission to address the remaining issues of liability, causation and quantum. The Supreme Court (Judge Lloyd-Jones delivering the opinion, with four concurring justices) dismissed the appeal.

Legal Issues Presented

1. Whether the MITCH-Accolade metal-on-metal hip system was defective within the meaning of section 3 CPA, having regard to the inherent propensity of such prostheses to shed metal debris and the associated risk of early revision.
2. Whether, notwithstanding prima facie evidence arising from professional concerns, regulatory notices and market withdrawal, the Lord Ordinary was entitled to find that the Appellant failed to prove defectiveness on the balance of probabilities.
3. Whether the principles of EU effectiveness and consumer protection required a less exacting evidentiary burden on the Appellant.

Arguments of the Parties

Appellant's Arguments

• Design Flaw: Metal debris allegedly created a higher risk of adverse reaction, earlier failure and inferior outcomes after revision compared with non-metal-on-metal devices.
• Prima Facie Evidence: Expressions of professional concern, regulatory alerts, and the Defendants’ voluntary withdrawal of the product demonstrated defectiveness.
• Effectiveness Principle: Requiring statistical proof rendered the exercise of EU consumer-protection rights “practically impossible or excessively difficult.”
• Fair Apportionment of Risk: Under the Directive, any doubt should be resolved in favour of consumer protection, permitting the court to draw adverse inferences from the Defendants’ conduct.

Defendants' Arguments

• Statistical Analysis: Uncontested evidence from Expert Witness Platt showed no reliable statistical indication that the product’s survivorship fell below accepted benchmarks once confounding factors and outlier surgeons were addressed.
• Lack of Specific Proof: Professional concern and regulatory notices related to metal-on-metal devices generally, not to this product in particular.
• Commercial Withdrawal: The product was withdrawn for commercial reasons (poor sales and the end of a supply agreement), not because it was known to be defective.

Table of Precedents Cited

Court's Reasoning and Analysis

1. Autonomous Standard of Safety: The Court reaffirmed that defectiveness is judged by the objective safety level that “persons generally are entitled to expect,” assessed at the time of supply but with the benefit of all current knowledge.

2. Entitled Expectation Criteria: At first instance, survivorship (time to revision) and outcome of revision were adopted as benchmarks. On appeal only survivorship remained in issue.

3. Evaluation of Statistical Evidence: The Lord Ordinary accepted Expert Witness Platt’s uncontested analysis that crude registry figures overstated failure rates because of small sample size, incomplete data, confounding patient factors and two outlier surgeons. When adjusted, the product’s ten-year revision probability fell within Guidance Institute benchmarks.

4. Prima Facie Indicators Re-examined: Professional concern, regulatory alerts and the urgent Field Safety Notice were all based on the same unadjusted registry statistic (10.7 % revision at four years). Given Expert Witness Platt’s analysis, the Court held those indicators no longer substantiated defectiveness.

5. Commercial Withdrawal: Findings of fact established that withdrawal stemmed from low sales and the lapse of a supply agreement, not safety concerns. No adverse inference could therefore be drawn.

6. Burden of Proof and Effectiveness: The Court held that national evidentiary standards did not make the claim “excessively difficult.” The Appellant had full opportunity to present expert and statistical evidence but failed to prove a defect on the balance of probabilities.

7. Appellate Deference: Applying the standard in appellate review, the Supreme Court found no legal error or perversity in the Lord Ordinary’s factual findings and therefore refused to disturb them.

Holding and Implications

APPEAL DISMISSED.

Direct Effect: The Appellant’s claim under the CPA fails; no remission to consider causation or quantum is required.

Broader Implications: The decision re-affirms that (a) metal-on-metal hip devices are not inherently defective merely because they shed debris, (b) raw registry data must be critically analysed before drawing inferential conclusions, and (c) the burden of proving defect remains with the claimant even in consumer-protection litigation. No new precedent was created, but existing CPA jurisprudence was consolidated.