Defective Medical Device Claims: Mesh, Hip Implants and Faulty Devices

What is a defective medical device claim?

This matters because a device can cause serious harm even where every clinician involved in your care acted entirely properly — the surgery may have been performed skilfully, with full and proper consent, and the harm can still trace back to a flaw in the product itself.

What examples of defective device claims exist in the UK?

Who do you actually claim against?

There are two distinct routes, and a claim can pursue either or both:

1. The manufacturer, under the Consumer Protection Act 1987. This creates strict liability: if the device was "defective" — meaning its safety fell below what people are generally entitled to expect, judged against comparable products — and that defect caused your harm, the manufacturer is liable regardless of how careful they were.
2. The surgeon, clinic or NHS trust, under ordinary clinical negligence. If the device itself was sound but it was the wrong choice for you, was implanted incorrectly, or you weren't properly warned of its risks under the Montgomery consent standard, that is a standard breach-of-duty claim against the clinician or trust — not a product claim.

Does a device causing harm automatically mean it was defective?

No — and this is where defective device claims differ most from standard clinical negligence. The courts have applied a demanding test for what counts as a "defect". In the 2018 Pinnacle metal-on-metal hip group litigation (Gee and others v DePuy International Ltd), the High Court held that a known, disclosed risk of a device shedding metal debris in ordinary use was not, by itself, a defect — the correct test was whether the product had an abnormal tendency to cause harm compared with similar products on the market. The claimants in that group action did not succeed on that issue.

This doesn't mean device claims are weak — pelvic mesh and PIP breast implant claims have succeeded in the UK — but it does mean the "defect" question turns on detailed regulatory and engineering evidence, not simply on the fact that harm occurred.

What is the time limit for a defective device claim?

The standard rule is the same three years from the date of knowledge that applies to other personal injury and clinical negligence claims. But product liability claims carry an additional rule: an absolute 10-year longstop from the date the manufacturer last put that device into circulation, under section 11A of the Limitation Act 1980 (inserted by the Consumer Protection Act 1987). Unlike the ordinary three-year limit, the courts have no discretion to extend the 10-year longstop, however reasonable the delay. If more than ten years have passed since the device was supplied, a product liability claim against the manufacturer is barred — even if your symptoms only appeared recently. A parallel clinical negligence claim against the clinician or trust may still be possible on the ordinary three-year rule, so it's worth having both routes checked.

What is a Group Litigation Order, and does my claim need one?

Where many people have been harmed by the same device, the court can make a Group Litigation Order (GLO) under CPR Part 19, Part III to manage the claims together — sharing the cost and evidence of establishing common issues, such as whether a particular device was defective, while each claimant's individual damages are still assessed separately. Metal-on-metal hip implants and pelvic mesh have both been the subject of GLOs in England and Wales. Not every device claim needs a GLO — it depends on how many other people were affected by the same product.

What evidence does a defective device claim need?

• Your full medical and surgical records, including the operation note recording exactly which device was used.
• The device's batch or serial number and implant card, where you have one — manufacturers are required to keep traceability records even where patients don't.
• Any MHRA (Medicines and Healthcare products Regulatory Agency) safety alerts, field safety notices or recalls relating to that device.
• Independent expert evidence — typically both a clinical expert (on your treatment) and, for the product liability limb, engineering or regulatory expert evidence on the device itself.

How is a defective device claim funded?

As with other clinical negligence and product liability claims, these are almost always funded on a Conditional Fee Agreement — no win no fee. You pay nothing upfront and nothing if the claim fails. Where a Group Litigation Order is in place, the costs of establishing the common issues are typically shared across the group.

Frequently asked questions

Related guides

• Medical negligence claims — complete guide
• Surgical negligence claims
• Solicitor vs claims management company