Module 17 2024

04/12/2024

Fault based liability (negligence) (1)

Whether injury is caused by the conduct of a person?

• Acts / omissions (negligence / carelessness) • Only concerned with inadequate quality of a product as this results from faulty behaviour (e.g. carelessness) All producers owe a legal duty of care to end users (EU have extended this for high- risk AI systems to “deployers” (see AI Act for definitions))

All other suppliers owe legal duties to take reasonable care within the sphere of their own responsibility

• Potentially includes Notified Body (Case C-219/15 Schmitt – v- TUV Rheinland) and in EU will likely include all suppliers in SaMD / AIaMD supply chain (draft EU AI Liability Directive) Quality of the conduct must fall below a reasonable standard (reasonable care and skill) morally characterised as implying fault

• Choice and control of the product development process • Verification and validation during development process • Appropriateness of manufacturing processes and materials • Warnings and instructions to enable safe use • Adequacy of post-market surveillance / corrective actions •EU MDR/IVDR: additional “economic operator” responsibilities •EU AI Act “provider”/”deployer” responsibilities

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Fault based liability (negligence) (2)

Any injured purchaser / user / bystander has a direct right of action against any person in the supply chain (particularly the manufacturer) if not too remote • Designer, importer, seller • AR, distributor, systems & procedure pack Mfrs and Sterilisers now more likely targets? • EU extended this for high- risk AI systems to “providers” and “deployers” (see AI Act for definitions) Claimant must usually prove all elements of the claim: • Burden of proof: usually on a balance of probabilities (51:49) • Sometimes: burden of proof reversed, e.g. if product fails unexpectedly following normal use • Draft EU AI Liability Directive alleviates claimants’ burden of proof: • Where D fails to disclose evidence pursuant to court order • Presumes causation if D breaches specified EU AI Act obligations directly intended to protect against damage and reasonably likely D’s breach influenced AIaMD output (or lack of output) and that that caused the damage • Duty Fault Causation injury / loss

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