Module 17 2024

04/12/2024

John Hastings v Finsbury Orthopaedics Ltd, Stryker UK Ltd [2022] UKSC 19

MoM prosthetic hip replacement

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Not defective:

• Endorsement of recent case law - Wilkes v DePuy and Colin Gee & Others v DePuy International Ltd • Objective test for defectiveness • There can be no entitlement to an absolute level of safety • Generalised expressions of professional concern were not determinative of a defect for the specific product in issue • Field safety notices and medical device alerts were considered in light of subsequent up-to-date evidence • A product recall did not automatically amount to evidence of a defect • Product met the regulatory standards and requirements at the time of manufacture. • Insufficient statistical data because it did not conclusively show a higher failure rate than expected, and the sample size was too small to establish a definitive pattern of defects. Additionally, the variability in patient outcomes made it difficult to attribute issues solely to the product.

– Hastings, who underwent a total hip replacement, alleged that the MoM product was

defective and sought damages under CPA.

SC Appeal = was there prima facie evidence giving rise to a non-rebuttable presumption proving Hasting’s case? – Professional concerns – Official Notices and Alerts – Product Withdrawal

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TOPRA MSc Module 17

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Interaction between the EU MDR and the EU product liability framework

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TOPRA MSc Module 17

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