Hastings v Finsbury Orthopaedics Ltd and another [2022] UKSC 19

Mr Hastings received a MITCH-Accolade metal-on-metal hip replacement in 2009, requiring revision surgery in 2012. He claimed the prosthesis was defective under the Consumer Protection Act 1987. The Supreme Court dismissed his appeal, finding he failed to prove the product was defective as statistical evidence did not establish survivorship rates below entitled expectations.

Facts

In 2009, the appellant Mr John Hastings underwent a metal-on-metal (MoM) total hip replacement using the MITCH-Accolade product manufactured by the respondents, Finsbury Orthopaedics Ltd and Stryker UK Ltd. In 2012, he required revision surgery. Mr Hastings claimed that the prosthesis was defective and sought damages under section 2 of the Consumer Protection Act 1987 (CPA), which implemented EU Directive 85/374/EEC on product liability.

Procedural History

Following a preliminary proof in the Outer House, Lord Tyre held that the appellant had failed to prove the product was defective. The Inner House (First Division) refused the appellant’s reclaiming motion. The appellant appealed to the Supreme Court.

Issues

The central issue was whether the MITCH-Accolade product was defective within the meaning of section 3 of the CPA, which defines a defect as existing where the safety of the product is not such as persons generally are entitled to expect. The specific question was whether certain propensities and risks inherent in MoM prosthetic hips rendered the product defective.

Basis of the Appellant’s Case

The appellant sought to establish defectiveness through two main arguments: (1) demonstrating design flaws showing greater risk compared to non-MoM prostheses, and (2) relying on prima facie evidence including professional concerns, the respondents’ withdrawal of the product from the market, and regulatory notices and alerts.

Judgment

Lord Lloyd-Jones, delivering the unanimous judgment, dismissed the appeal. The Court held that the appellant failed to establish on the balance of probabilities that the MITCH-Accolade product was defective.

The Test for Defectiveness

The parties agreed that the test of entitled expectation was whether the level of safety of the MITCH-Accolade product would be worse than existing non-MoM products, using time to revision (survivorship) as the primary criterion.

Statistical Evidence

The respondents’ expert, Professor Platt, provided unchallenged statistical evidence demonstrating that available data was insufficient to reliably establish that the MITCH-Accolade product’s revision rates were out of line with relevant benchmarks. Professor Platt concluded:

My examination of available data on revisions of the MITCH-Accolade product indicates that there are limited data available to reliably estimate the survivorship of the MITCH-Accolade and to compare its survivorship to other THR prostheses… I find no reliable evidence that the survivorship of the MITCH-Accolade is out of line with benchmarks.

Prima Facie Evidence

The Court rejected the appellant’s argument that professional concerns, product withdrawal, and regulatory notices established a prima facie case that remained uncontradicted. Lord Lloyd-Jones found that:

1. Professional concerns related to MoM prostheses generally, not specifically to the MITCH-Accolade product;

2. The withdrawal from the market was for commercial reasons, not safety concerns;

3. The regulatory notices were based on the same statistical data that Professor Platt’s analysis had shown to be unreliable for drawing conclusions about defectiveness.

The Court held that Professor Platt’s evidence was not neutral but actively undermined the prima facie case by demonstrating that confounding factors, including outlier surgeons, patient demographics, and lowered revision thresholds following media coverage, meant the raw NJR data could not support a finding of defectiveness.

Standard of Review

The Court noted that to reverse the Lord Ordinary’s findings of fact, it would need to be satisfied that he erred in law, made findings without evidential basis, or was plainly wrong. None of these requirements were met.

Implications

This case provides important guidance on product liability claims under the CPA, particularly regarding:

1. The burden of proof remains on the claimant to establish defectiveness, and prima facie evidence can be rebutted by expert analysis;

2. Courts may consider all evidence available at trial, including material developed after the product was withdrawn, to assess whether entitled expectations were met;

3. Statistical evidence must be properly adjusted for confounding factors before conclusions can be drawn about product performance;

4. The principle of effectiveness in EU law does not require courts to accept prima facie evidence when it has been properly contradicted by expert analysis.

The judgment confirms that while the CPA introduces strict liability, claimants must still prove the existence of a defect meeting the statutory definition, and courts will carefully scrutinise the evidential basis for such claims.

Verdict: Appeal dismissed. The appellant failed to prove on the balance of probabilities that the MITCH-Accolade product was defective within the meaning of the Consumer Protection Act 1987.

Source: Hastings v Finsbury Orthopaedics Ltd and another [2022] UKSC 19