Michaela is a Regulatory Partner who advises clients in the pharmaceutical, healthcare, medical device, digital health, cosmetic, food, video game, software and general consumer product sectors on various regulatory compliance matters.
She frequently advises clients on the applicable regulatory framework, regulatory approval, labelling, packaging, traceability, safety and liability issues. She has also advised clients on matters of regulatory compliance in the context of due diligence.
Michaela has advised clients on regulatory investigations by enforcement authorities, including an investigation as part of the Horse Meat scandal. She has also advised and represented clients in enforcement action, including the defence of criminal prosecutions for breaches of consumer protection legislation. She has overseen the implementation and coordination of high volume product withdrawals and product recalls, including rectification strategies, in multiple jurisdictions.
Michaela has acted on behalf of clients in significant commercial disputes, injunctive relief, judicial review and product liability litigation (including representing clients in class actions in relation to silicone breast implants and metal on metal hip implants). She has also represented and advocated on behalf of clients at inquests before the Coroner’s Court.
Michaela also has many years of experience representing clinicians and hospitals in clinical negligence claims with a particular specialism in catastrophic and paediatric claims. She has significant experience advising hospitals and clinicians on a wide range of legal, ethical & regulatory issues. Areas of expertise include patient capacity, consent, corporate and clinical governance, clinical trials, risk management policies and data protection/freedom of information law in the healthcare sector. Prior to joining Mason Hayes & Curran as a Partner, Michaela worked in London for a number of years with a leading Life Sciences and Technology firm.
Product Regulatory, Safety and Recall
Life Sciences Regulatory Law: Pharmaceutical, Medical Devices & Cosmetics
‘The rise of software as a product – does the product liability framework apply?’ International Underwriting Association, London, May 2019
Co-authored the Chapter on Ireland in “Product Recall, Liability and Insurance – A Global Guide”, December 2012
British Institute of International Comparative Law (BIICL)
BIICL’s Product Liability Forum
International Consumer Product Health and Safety Organization (ICPHSO)
International Association of Defence Counsel
University College Dublin, BCL
Law Society of Ireland, Diploma in Family Law
Solicitor, England & Wales
Attorney at Law, Admitted to practice in New York (non-practising) 2011