Bringing a Defective Medical Product Claim
Medical negligence and product liability claims here at McCarthy + Co Solicitors LLP are overseen by our head litigation lawyer, John McCarthy. John has acted in a wide variety of personal injury, medical negligence, and defective medical product cases at Circuit Court, High Court, and Supreme Court level.
John has acted for many patients affected by defective implants and devices. He was closely involved in the litigation that followed the worldwide recall of the DePuy ASR hip replacement system, and more recently has acted for patients fitted with the DePuy Attune knee system.
Expertise in product liability claims
Although this area sits within our medical negligence practice, a defective device claim is legally different from a medical negligence claim. A negligence claim is about whether a doctor, surgeon, or hospital fell below the standard of care expected of them. A defective product claim, by contrast, is about the product itself, and is brought against those responsible for placing it on the market. It is governed by the Liability for Defective Products Act 1991, which implements European product liability law in Ireland.
The great advantage of this route is that it operates on a strict liability basis. This means that, if you can show the product was defective and that it caused your injury, you do not have to prove that anyone was negligent, or even identify exactly how the defect arose. A claim can be brought against the producer, which includes the manufacturer, a business that put its own brand on the device, and the importer who brought it into the European Union. In some cases, a defective device claim and a medical negligence claim can run alongside each other, for example where a device was both faulty and negligently fitted, and we will advise on every route open to you.
Time limits for defective product claims
The time limits for a defective product claim differ from those in a negligence claim. Instead of the usual two years, a claim under the 1991 Act must generally be brought within three years, running from the date you became aware of the injury, the defect, and the identity of the producer. There is also a ten-year ‘long-stop’, after which a strict product liability claim generally cannot be brought, running from when the product was first put into circulation.
What ‘in circulation’ means can be significant. A device design might be twenty years old, but the better view is that the ten years runs from when the particular product you received was actually supplied, that is, sold or put into use in your procedure, rather than from when the design first appeared. This can make the difference between a claim being available or not, so it is worth taking advice rather than assuming you are out of time.
How the law is changing
Product liability law is being significantly reformed. A revised European Product Liability Directive, Directive (EU) 2024/2853, must be brought into Irish law by 9 December 2026, and will apply to products placed on the market after that date, while devices supplied before then remain under the Liability for Defective Products Act 1991. One change is especially relevant to medical devices: because some injuries from implants take many years to emerge, the new rules extend the long-stop from ten years to twenty-five years in cases of latent personal injury, where symptoms are, on the medical evidence, slow to appear. The new regime also widens the range of businesses that can be held liable and eases the burden of proof in technically complex cases. We can advise on which regime applies to your situation.
“From Start to Finish, John and his team were extremely professional. Knowing it would be a long road, he took on my case and saw it out to the end with a positive result. The guidance and care that I was shown got me through the process. I would recommend McCarthy + Co. to all my family and friends for any future business. I will forever be indebted to John and his team for changing my life circumstances.”
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Types of Defective Products
Some of the key areas where our experienced medical negligence team provide guidance:
Hip Replacement Devices
Assisting clients who have sustained injuries and financial losses as a result of being fitted with a defective hip replacement implant.
Knee Replacement Devices
Assisting clients who have suffered ongoing health problems and incurred financial losses following the fitting of a defective knee replacement implant.
Spinal Cord Stimulators
Assisting clients who have suffered significant harm, such as nerve damage and chronic pain, following a spinal cord stimulator implant.
Defibrillators and Pacemakers
Assisting clients who have suffered heart health issues or related problems due to be fitted with a defective pacemaker or defibrillator.
Surgical Mesh Implants
Assisting clients affected by complications from surgical mesh implants used in hernia or pelvic organ prolapse procedures.
Breast Implants
Assisting clients who have suffered due to implant rupture, leakage, or illness linked to breast implants, such as BIA-ALCL.
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Meet John McCarthy
John McCarthy is a partner at McCarthy + Co Solicitors LLP, with more than 20 years of experience in medical negligence and product liability claims. He has represented dozens of clients fitted with defective devices in high-value cases at the High Court and Supreme Court levels.
John holds a diploma in civil litigation from the Law Society of Ireland and is a member of Action Against Medical Accidents (AvMA), the leading patient safety charity. He is also the author of A Patient’s Guide to Bringing a Claim for Medical Negligence. If you have suffered as a result of a defective medical device, you can contact John directly at john@mccarthy.ie.
Frequently Asked Questions
Some of the questions often posed to our medical negligence team.
What is a defective medical product?
A defective medical product refers to any medical device or pharmaceutical that fails to perform as intended, leading to harm or injury to the patient. This can result from design flaws, manufacturing errors, or inadequate instructions for use. Such defects can compromise patient safety, leading to adverse health outcomes, including physical injury, illness, or worsening of an existing condition.
Is this a product liability claim or a medical negligence claim?
Usually a product liability claim. If the harm was caused by the device itself being faulty, the claim is against the producer under the Liability for Defective Products Act 1991, on a strict liability basis. If the harm was caused by how a doctor or hospital treated you, that is a medical negligence claim. Sometimes both apply, and we will advise on the best approach.
Who can I claim against?
The ‘producer’, which is wider than just the manufacturer. It includes the maker of the device or a component within it, a business that placed its own brand on it, and the importer who brought it into the European Union. Identifying the correct party, sometimes more than one, is part of what we do.
What is the HPRA, and do recalls matter to my claim?
The Health Products Regulatory Authority is the Irish body that regulates medical devices and medicines, and it issues safety notices and recalls when a problem is identified. A recall or field safety notice affecting your device can be useful evidence in a claim, though you do not need to wait for one, or rely on one, in order to bring a claim if you have been injured.
How can a solicitor help me bring a claim?
A defective device claim can be technical, so a solicitor takes that work on for you: tracing the correct manufacturer or importer, gathering the medical records and expert evidence needed to show the product was defective and caused your injury, checking the time limits, and dealing with the manufacturer and its insurers to secure the compensation you are owed.
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Examples of products we have brought claims against
Useful resources
Some links relating to this topic that you may find useful.
- HPRA – Quality Defects and Recalls
- National Library of Medicine – Drug and medical device product failures and the stability of the pharmaceutical supply chain
- Medical Device Network – The world’s biggest medical device recalls
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