Module 17 2024

04/12/2024

Judgment: Wilkes v DePuy International Limited “Safety” is inherently and necessarily a relative concept

“Fair apportionment of risk” – legislation not driven solely by consumer interests

Focus should be on ascertaining whether there is a defect and if so, what that might be

Defectiveness test is not assessed by reference to actual or notional persons’ expectations Claimant need not prove cause of lack of safety, or why product failed ( Ide v ATB Sales Ltd [2008] EWCA Civ 424) but must prove a causal link between defect and damage No restriction on relevant circumstances which should be taken into account in connection with the defectiveness test Focus must be on the product itself when determining ‘safety’ – no undue concentration on acts / omissions of designer/producer. • Question whether a risk is ‘avoidable’ unlikely to be fruitful for implantables but may be relevant to level of safety public generally entitled to expect

• Possible disadvantages of different design solutions must be considered Compliance with specification and standards both relevant circumstances

Knowledge of the medical profession, IFU warnings are relevant circumstances

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Gee & Others v DePuy International Limited [2018] EWHC 1208 MoM Hip Implant Group Litigation – 1st instance England (2018)

Judgment: • PLD balances interests of consumers and producers - system of non-fault liability for products that fail to meet the standard of safety •‘Defect’ = failure to meet an objective standard of safety that Court must evaluate - Court must be flexible when determining appropriate standard of safety • All circumstances with a bearing on the safety of the product should be taken into account • Only an abnormal propensity to cause ARMD, otherwise expressed as a materially greater risk of the product failing within 10 years, would amount to a defect • Level of safety to be measured by reference to what was known (re safety) at the time of placing on the market. • Subsequent performance of later products, incl within the Pinnacle System, could not inform entitled expectations as to the level of safety •“Worst - in class” product not necessarily defective

Group action preliminary issue to determine if Pinnacle System hip was defective or not

Alleged Adverse Reaction to Metal Debris (ARMD) caused by the debris generated by prosthesis, which necessitated revision surgery

Alleged defect:

• The product’s propensity to shed metal debris and consequently to require revision surgery; or • Materially increased risk of the prosthesis failing within 10 years, when compared to an appropriate comparator, also described as an abnormal risk of damage

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