Product Regulation & Liability: Experience
Product Recall and Corrective Action
- Global cosmetic company on an urgent consumer product withdrawal following alleged product safety concerns on consumer goods placed on the Irish and UK markets. This mandate required advising on and engagement with the Irish regulator.
- Regulatory and strategic advice to a listed Chinese biotech company on the voluntary recall of its SARS COVID-19 antigen self-test kits from the EU market, managing a related investigation by the HPRA and advising on the potential contractual dispute with a European distributor.
- Irish wholesale distribution company in pursuing a breach of contract claim against a Turkish manufacturer arising from the supply of defective hand sanitiser gel during the COVID-19 pandemic.
Regulatory Engagement and Compliance
- British American Tobacco in seeking to challenge the validity of a delegated directive which sought to restrict the placing on the market of certain novel tobacco products with characterising flavours. The judicial review proceedings required a preliminary reference to the CJEU.
- A global medtech company in relation to a coroner’s inquest following the death of a patient who had one of their life-saving devices fitted.
Product Liability Litigation
- An international pharmaceutical company in respect of a product liability dispute relating to allegedly defective pipework which was installed by a third party at the company’s biological treatment plant. The dispute, which was ultimately settled at mediation, centred around the interpretation of welding requirements required under contract and by reference to industry standards for facilities of this type.
- Acting for one of Ireland and Europe’s largest beef processors and pet food manufacturers in defending contractual and product liability issues involving customers, suppliers and consumers, reputational and regulatory issues arising from the ‘horsemeat crisis’.
- A global car manufacturer on a police investigation, coroner’s investigation and personal injuries actions arising from a fatal accident in one of their vehicles.
- World-leading soft commodities provider in defending two multi-million Commercial Court claims arising from allegedly contaminated product imported into the EU and allegedly used in feed for elite racehorses.
Marketing and advertising
- A global technology company on regulatory restrictions on the advertising of medical products and services.
- British American Tobacco on a wide range of product liability issues, including marketing/advertising restrictions, new category product compliance and consumer obligations.
Mass Claim Defence
- Volkswagen on all aspects of the diesel emissions issues.
- Smith & Nephew Orthopaedics in the ongoing defence of multiple Irish product liability claims in respect of hip replacements.
- State Claims Agency on behalf of the Health Service Executive in the defence of more than 110 High Court claims arising out of the historic obstetric practice of symphysiotomy.