DePuy Spinal Implants being recalled in UK amid safety concerns
The lack of legislative safeguards in place for medical devices (as opposed to medicines) here in Ireland is again brought into focus by the recent recall of DePuy Spinal Implants in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA).
DePuy advised that patients who have received affected devices could be at risk for poor spine biomechanics, pain, reversible or irreversible spinal nerve injuries and malunion/non-union.
We in Cantillons have already written about the need for strong regulation of the medical device industry in Ireland.
As set out in our November blog, the Health Product Regulatory Authority (HPRA) is responsible for the regulation of medical devices and for the monitoring of the safety of medical devices on the Irish market. However the HPRA is dependent on stakeholders such as patients and clinicians to make voluntary disclosures to it on adverse events pertaining to medical devices. On a search of the HPRA website, at the time of writing this blog, I can find no such recall here in Ireland of the DePuy spinal implants. It may be that they ( hopefully) were not used in Ireland. Only time will tell. In the meantime, it serves as yet another reminder that urgent, appropriate action needs to be taken to regulate the medical device industry.
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In her twenty years as a practising solicitor, Karen has worked with a number of leading law firms in Limerick and Cork where she has acquired extensive experience in all areas of the law, with a particular expertise in medical negligence cases.
Karen has represented clients effectively in many forums including the District Court, Circuit Court, High Court, Employment Tribunals and Coroner’s Court. She has acted for, and advised, State Bodies in respect of all areas of the law to include childcare law; employment issues; food safety and health and safety issues.
Karen joined Cantillons Solicitors in November 2009 and works in the Medical Negligence Department practising clinical negligence litigation. She is expertly assisted by Patricia Sisk and April Wiseman, Legal Assistants.
She is very proud to be a member of the medical negligence team which has been involved in precedent-setting cases since 1980 and which received the inaugural award of Litigation Team of the Year, National Irish Bank Law Awards in 2012.
Karen regularly attends international conferences in order to add to her pool of her experts and ensure access to the world’s best. She is also regularly asked to speak at national and international conferences concerning medico-legal issues. She is a regular speaker at the annual Medical Law Conference; giving presentations on healthcare law, practice and procedure to employees in the healthcare section and fellow lawyers. This lecturing experience means that Karen has an excellent grasp of law in theory as well as in practice.
Karen has featured on national television and on local and national radio in relation to this specialised area of medical negligence litigation.She has been commissioned to write opinion pieces on topical issues in the medical negligence area, published in national newspapers. Notably, she first highlighted in the Irish Examiner, the Minister for Health’s failure to introduce a statutory Duty of Candour- a legal requirement for medical staff, nurses and management to tell patients and their families if a mistake has been made which adversely affects the patient’s health – despite the Minister’s promise to do so.
Karen also writes a weekly column in a local daily newspaper, the Evening Echo, addressing reader’s legal queries. This column appears in Monday’s edition of the paper.
Karen has developed real expertise in her field and has shown great dedication in pursuing complex injury cases to settlement.
Karen gets referrals from patients nationwide. She represents her patients with determination and compassion.
- BCL Honours 1992
- Admitted to the Roll of Solicitors in Michaelmas 1996
- Former Secretary of Limerick Bar Association
- Former member of the Litigation Committee of the Law Society of Ireland
- Member of the Medical Injuries Alliance
- Member of Action Against Medical Accidents (AvMA)