Introduction

The case of John Hastings against (First) Finsbury Orthopaedics Ltd; and (Second) Stryker UK Ltd ([2021] ScotCS CSIH_6) adjudicated by the Scottish Court of Session addresses critical issues surrounding product liability under the Consumer Protection Act 1987 (CPA 1987). This commentary delves into the intricate legal principles established by the court, particularly focusing on the definition of product defect and the allocation of the burden of proof in the context of medical devices.

Parties Involved:

• Pursuer and Reclaimer: John Hastings
• Defenders and Respondents: Finsbury Orthopaedics Limited and Stryker UK Limited

The primary issue revolved around whether the total hip replacement (THR) prosthesis used by Mr. Hastings was "defective" under section 3 of the CPA 1987, thereby rendering the manufacturers liable for any resultant damage.

Summary of the Judgment

Mr. Hastings underwent a metal on metal (MoM) total hip replacement in 2009, which later required revision surgery in 2012. He alleged that the prosthesis was defective, leading to an adverse reaction to metal debris (ARMD). After preliminary hearings, the Lord Ordinary found in favor of the defendants, concluding that Mr. Hastings failed to prove the defectiveness of the prosthesis.

The central determination hinged on whether the prosthesis was less safe than what persons generally were entitled to expect at the time of its supply. The court meticulously examined statistical data, expert testimonies, and regulatory actions to assess whether the manufacturer's product met the requisite safety standards.

Ultimately, the court held that while there was prima facie evidence suggesting potential defects in MoM prostheses, Mr. Hastings did not sufficiently demonstrate that the Mitch/Accolade prosthesis specifically fell below the standard of safety expected.

Analysis

Precedents Cited

The judgment extensively referenced several key cases to shape its legal reasoning:

• Gee v DePuy International [2018] Med LR 347: Established a flexible approach to determining product defects, emphasizing the balance of safety expectations without introducing negligence.
• A v National Blood Authority (No. 1) [2001] 3 All ER 289: Highlighted that the relevant degree of safety is based on what the public is entitled to expect, not merely what they do expect.
• W v Sanofi Pasteur [2017] 4 WLR 171: Warned against imposing excessive evidential burdens on consumers, thereby potentially undermining the CPA 1987’s effectiveness.
• Wilkes v DePuy International [2018] QB 627: Reinforced the notion that product safety should be assessed objectively, balancing benefits against inherent risks.

Legal Reasoning

The court's legal reasoning was methodical, focusing on two primary questions:

1. What was the entitled expectation of safety for persons generally regarding the prosthesis?
2. Did the prosthesis fail to meet this expectation?

The Lord Ordinary emphasized an objective standard, determining that the Mitch/Accolade prosthesis needed to match the safety expectations of contemporary non-MoM prostheses. Critical considerations included:

• The overall survivorship rates of the prosthesis compared to benchmarks set by health authorities like the National Institute for Health and Clinical Excellence (NICE).
• The reliability and sufficiency of statistical data presented by defendants.
• The impact of external factors such as regulatory alerts, market withdrawal, and evolving medical standards.

The court concluded that while there was evidence suggesting higher revision rates for MoM prostheses, the specific Mitch/Accolade prosthesis did not demonstrably underperform relative to the defined safety expectations.

Impact

This judgment has significant implications for future product liability cases, especially those involving complex medical devices. Key impacts include:

• Clarification of Defectiveness: Reinforces the necessity for plaintiffs to provide robust evidence that a specific product fails to meet the safety standards expected by the general public.
• Burden of Proof: Affirms that while strict liability is imposed, the onus remains on the claimant to substantiate defectiveness without undue burdens.
• Regulatory and Statistical Scrutiny: Highlights the critical role of reliable statistical evidence and the limitations of regulatory notices in establishing product defects.
• Standard of Review: Emphasizes the appellate court's restraint in overturning factual determinations unless clear legal errors are evident.

Complex Concepts Simplified

1. Product Defect under CPA 1987

A product is deemed "defective" if its safety is not what persons generally are entitled to expect. This encompasses not just physical fitness but also safety concerning potential personal injury risks.

2. Burden of Proof

Under the CPA 1987, while liability is strict, meaning plaintiffs do not need to prove negligence, they must still demonstrate that the product was defective. This involves showing that the product's safety fell below reasonable expectations.

3. Confidence Interval (CI)

A statistical range that estimates where a true value lies with a certain level of confidence (e.g., 95%). In this case, it was used to assess the reliability of revision rates for the prosthesis.

4. Adverse Reaction to Metal Debris (ARMD)

A medical condition arising from the body's reaction to metal particles shed by metal-on-metal prostheses, potentially leading to tissue damage and implant failure.

5. Survivorship Rate

The proportion of implants that remain functional without requiring revision surgery over a specified period.

Conclusion

The judgment in John Hastings against Finsbury Orthopaedics Ltd and Stryker UK Ltd serves as a pivotal reference in understanding the application of the Consumer Protection Act 1987 within the realm of medical device liability. By meticulously dissecting the standards for product defectiveness and the requisite burden of proof, the court has delineated clear boundaries for both plaintiffs and defendants in future litigation.

Key takeaways include:

• Claimants must present substantial evidence that specific products do not meet the safety expectations established by comparable alternatives.
• Regulatory actions and market withdrawals, while influential, do not singularly determine product defectiveness without supporting statistical and scientific evidence.
• The appellate courts maintain a deferential stance towards trial court findings, ensuring that factual determinations are respected unless clear legal missteps are evident.
• The necessity for reliable and comprehensive data in product liability claims, particularly for technologically complex and regulated products like medical devices.

This case underscores the delicate balance courts must maintain between consumer protection and fair treatment of manufacturers, ensuring that liabilities are imposed based on clear and compelling evidence of defectiveness.