Types of Medical Product Liability Claims
Debilitating ongoing health problems and serious injuries can be sustained by patients due to many different types of faulty or wrongly administered medical products. Click on the links below for further information on the types of cases that our medical negligence team deal with.
The phrase “medical product liability” refers to the legal responsibility of manufacturers, suppliers, distributors, and healthcare providers for the safety of medical products and devices they produce, market, or use. This liability is typically associated with claims that a medical product is defective or has caused harm to a patient. The key aspects of medical product liability include:
- Defective Product Claims – These claims allege that a medical product had a design, manufacturing, or marketing defect. A design defect means the product was inherently unsafe even when made correctly. A manufacturing defect occurs when a product, though properly designed, is made incorrectly. Marketing defects involve inadequate warnings or instructions.
- Standard of Care – The manufacturers and suppliers of medical products are expected to meet certain standards of care in the design, production, testing, and labeling of their products. This standard is often based on what a reasonable entity in their position would do.
- Causation – For a successful medical product liability claim, it must be proven that the product directly caused harm to the patient. This involves showing that the injury would not have occurred without the defective product.
- Duty to Warn – Manufacturers and suppliers have a duty to warn patients and healthcare providers of the known risks associated with their products. Failure to provide adequate warnings or instructions can lead to liability if patients suffer injuries as a result.
- Strict Liability – Ireland, as a member of the European Union, adheres to the EU Product Liability Directive (85/374/EEC), which establishes the principle of strict liability for defective products. Under this directive, if a medical product is found to be defective and causes harm, the manufacturer may be held liable for damages.
- Compensation – Victims of defective medical products can seek compensation for damages such as medical expenses, lost wages, pain and suffering, and sometimes punitive damages.
Medical product liability is a crucial aspect of consumer protection law, as it provides a pathway for recourse for patients who are harmed by medical products, and it encourages healthcare providers and manufacturers to manage and produce safer products.
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Frequently Asked Questions
Some of the questions we are often asked about medical product liability.
Which key Irish law governs medical product liability?
The Liability for Defective Products Act, 1991, incorporates the EU Product Liability Directive into Irish law, establishing the principle of strict liability for damage caused by defective products. Under this Act, producers or suppliers of products, including medical devices and pharmaceuticals, can be held liable for injury or damage caused by defects in their products. A product is deemed defective if it fails to provide the safety someone is entitled to expect, taking into account all aspects including product presentation and use. In the context of medical products, this means manufacturers of medical devices, drugs, or other healthcare-related products could be liable if their product is found to be defective and causes harm to a patient, irrespective of whether there was negligence in the manufacturing or distribution process. This Act is a cornerstone of consumer protection and patient safety in Ireland, ensuring accountability in the healthcare industry.
What are the laws specifically governing medical products in Ireland?
The Irish Medicines Board Act, 1995, established the Irish Medicines Board (now known as the Health Products Regulatory Authority, HPRA), which is responsible for regulating medicinal products and medical devices in Ireland. The Act empowers the HPRA to ensure that medicines and medical devices available in Ireland meet appropriate standards of safety, efficacy, and quality. While the Act itself does not deal directly with medical product liability claims, the standards and regulations enforced by the HPRA are critical in determining the safety and efficacy of medical products. Compliance with these standards is a key factor in product liability cases. If a medical product approved by the HPRA is later found to be defective and causes harm, this could potentially lead to liability claims against the manufacturer or supplier, under the principles established by the Liability for Defective Products Act, 1991. Therefore, the Irish Medicines Board Act plays a significant indirect role in the context of medical product claims in Ireland.
What is The European Union Medical Device Regulation?
The European Union Medical Device Regulation (EU MDR) significantly updates the regulatory framework for medical devices in the EU, replacing previous directives. This regulation introduces stricter pre-market requirements for medical devices, demanding comprehensive documentation and clinical evidence to ensure safety and effectiveness. It emphasises post-market surveillance, requiring manufacturers to monitor their products' performance after market entry. The introduction of a Unique Device Identification (UDI) system enhances device traceability. EU MDR expands its scope to include devices not previously regulated, such as certain aesthetic products. The regulation also aims to improve transparency through a centralised EU database on medical devices (EUDAMED). Initially set for implementation by May 2020, the transition period was extended due to the COVID-19 pandemic. These changes, while enhancing patient safety and device tracking, also present challenges for smaller manufacturers due to increased compliance costs and complexity. Overall, EU MDR aims to balance patient safety with medical innovation.
Do I need a solicitor to bring a medical product liability claim?
While not legally mandatory, a solicitor's expertise is invaluable in navigating the complex legal and regulatory landscape of medical product liability. An experienced solicitor can effectively manage the intricate process, from filing the claim to negotiating with manufacturers and insurers. They ensure your rights are protected and enhance the likelihood of securing fair compensation. Given the potential challenges and the importance of your claim, professional legal guidance is strongly advised to maximise your chances of a successful outcome.
About McCarthy + Co
The most important thing you can do to give you the best chance of a successful claim is to work with a firm of solicitors who have expertise in the field. McCarthy + Co. are medical negligence claims specialists with more than 30 years of experience in providing legal advice, guidance and assistance to clients across Ireland.
We are a family-run business with offices in Dublin and Cork, but we have dealt with clients everywhere from Galway and Limerick to Waterford. We are honest, plain-speaking and thorough – we will work alongside you to ensure that you get the compensation that you deserve.
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Flor McCarthy wears multiple hats, not only as the managing partner of one of Ireland’s leading law firms, but also as an author, speaker and an acknowledged expert in client service, innovation and marketing.
Beginning his academic journey at UCC, Flor furthered his education with a master’s degree in law from UCD. After gaining valuable experience as a solicitor in Dublin, the allure of home and the family brought him back to West Cork to contribute his expertise to the family business.
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John McCarthy is a seasoned solicitor with almost 20 years of experience, specialises in personal injury and medical negligence claims, focusing particularly on high-value compensation cases. His extensive litigation experience spans Circuit Court, High Court and Supreme Court levels.
John's practice involves a diverse range of cases, from personal injury and wrongful death to property damage, defective products, professional negligence and judicial reviews.