Product Regulation & Liability

Our Product Regulation and Liability team provides comprehensive advice on all aspects of product regulation, liability, and product safety law from both a domestic and international perspective.  We have particular strength in managing regulatory investigations and enforcement actions, at both a domestic and international level.

We have a breadth of experience in advising at all stages of the product lifecycle. We help all players in the supply chain, including manufacturers, distributors, retailers, importers, and exporters to meet their compliance obligations, to balance risks and to protect their legal position. This includes advice on contractual, legal, and regulatory issues concerning the development and launch of products including labelling and advertising/consumer and retail advice. We also guide clients through product crisis management and risk and reputational issues as they arise, to include advising on notifications to relevant regulatory authorities, risk assessment and product recall as well as investigations and inspections.

We provide both general and sector-specific advice across a broad range of products and industries, including food and beverage, tobacco, pharmaceuticals, and medical devices, automotive (including autonomous driving), and electronics. We also have significant experience in managing and defending mass tort/contract claims arising from product liability issues arising from allegedly defective products, which often have an international and multi-jurisdictional element.

With developments in technology, coupled with software considerations, the area of product law is undergoing significant reform at a European level, with a new General Product Safety Regulation operational from December 2024 and legislative overhaul of the almost forty year old Product Liability Directive almost complete. Our specialist team is closely monitoring developments and assisting clients in terms of compliance with these changes.

Experience

  • Volkswagen

    on all aspects of the emissions issues.

  • John Deere

    in the defence of product liability claims.

  • Smith & Nephew Orthopaedics

    in the ongoing defence of multiple Irish product liability claims in respect of hip replacements.

  • Key Safety Systems

    in the defence of product liability claims.

  • State Claims Agency

    on behalf of the Health Services Executive in the defence of more than 110 High Court claims arising out of the historic obstetric practice of Symphysiotomy.

  • British American Tobacco

    in product liability matters and in the successful defence of the first regulatory prosecution under new Irish marketing legislation.