Module 5 Presentations

19/07/2024

Strict liability for a defective product

• Examples of defect in a clinical trial situation – Manufacturer • IMP contaminated • IMP inconsistent with specification – Sponsor

• IMP design results in unacceptable incidence of adverse events • Information/warnings provided to investigators/patients inadequate – CRO/Investigator • IMP contaminated during storage

NB: Where a manufacturer/sponsor has prepared new formulation of comparator product, he may be liable in respect of any defect, even if active ingredient authorised.

The Organisation for Professionals in Regulatory Affairs

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Strict liability in the clinical trial context

Likelihood of successful claim – Difficult for claimants to establish “defect” in view of uncertain effects of experimental treatment – particularly if patient information sheet includes adequate warnings. – Development risks defence may provide answer even if product is found to be defective. – Causation also problematic unless “fingerprint” injury.

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The Organisation for Professionals in Regulatory Affairs

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