Experience Advising:

• A global medical device company on the defence of metal-on-metal hip replacement cases for alleged product liability and in respect of other surgical devices.
• Revlon Consumer LLC on the recall of certain batches of its Mitchum cosmetic products range including its communication with the Irish regulator, HPRA (Health Products Regulatory Authority).
• Renew Pharmaceuticals Ltd and Diagnostic Green Limited on the Irish pharma regulatory due diligence conducted in the context of the IPO of shares in UltraGreen.ai on the SGX-ST Singapore.
• 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 HPRA and advising on the potential contractual dispute with a European distributor.
• An Irish laboratory on a suite of documents to support clinical genetic testing services using next generation genetic sequencing platforms in respect of INAB accreditation.
• A global pharmaceutical company on its application to the HSE for reimbursement of an anti-retroviral medicine under the Health (Pricing and Supply of Medical Goods) Act 2013 (the 2013 Act).
• A multinational nutrition company on the HSE Medicines Management Programme proposed process for the identification of preferred high protein oral nutritional supplements and drafting legal submissions based on the 2013 Act for EU and Competition Law.
• A global manufacturer of human generic medicines on regulatory and compliance issues regarding pricing, promotion, supply chain, High Tech Drugs Scheme and drafting various contractual agreements.
• A large acute hospital on the amendment of its charter by Ministerial Order, and on engagement with the Irish Department of Health and the Irish Charities Regulator.
• An Independent External Review group on their review of a patient complaint in respect of causation of an unexplained injury to a vulnerable resident of a healthcare facility and their review of the internal decision in response to the original complaint.
• Exponent Private Equity on the Irish regulatory aspects of its acquisition of Chanelle Pharma the largest indigenous pharma company in Ireland and the largest manufacturer of human and veterinary generic pharmaceuticals.