Laws, Vol. 15, Pages 1: UK Consumer Protection and the Debate for Reform in Medical Device Liability

Laws doi: 10.3390/laws15010001

Authors:
Nicholas T. H. Farr
Elliot J. Owen
Rohan M. Bhalekar

The long-stop rule, under the UK Consumer Protection Act (CPA) 1987, imposes a 10-year limitation period for product liability claims, providing legal certainty for manufacturers and consumers. However, this timeframe is increasingly problematic in the case of medical devices, particularly implantable ones, which can fail decades after implantation. This review considers an extension to the long-stop period for medical devices, emphasising the need for patient protection, legal clarity, and reduced clinician burden, and contrasts the current UK system with the EU’s proposed 25-year long-stop period under the recently implemented 2024 Product Liability Directive. Through case studies, including surgical mesh and orthopaedic implants, the discussion highlights the challenges posed by delayed failure modes and the resulting difficulties in seeking redress within the 10-year window. Lastly, the role of publicly funded redress schemes and the evolving legal landscape are examined, underscoring the importance of reconsidering the current statutory limitations. Extending the long-stop period, combined with the use of explant analysis to evaluate defective medical devices, is proposed as a means to enhance patient safety and align with ongoing advancements in medical technology and regulation.

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Nicholas T. H. Farr www.mdpi.com