Medical Device Liability & Claims

Replacement hip and knee joints, pacemakers, contraceptive devices, cosmetic implants, surgical tools, and insulin pumps are all types of medical products and devices. If you have been injured as a result of a defect in such a medical product or device then you may have a potential claim.

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The Consumer Protection Act 1987, provides both protection and a method of seeking redress when someone has been injured and/or damage has been caused by a (medical) product or device.

For a claim to succeed it needs to be proven that (1) the product / device was defective and (2) it was that defective product / device that was wholly or in part responsible for the damage or injury.

The procedures for testing medical products and devices, used by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) and European Agencies are extremely rigorous. Unfortunately; and even with these stringent tests and checks, some clinical negligence claims can arise as a result of defective medical devices and products.

The failure of a medical product or device (however so caused) can have varying and sometimes catastrophic effects on the individual concerned. Injuries arising from defective medical products and devices can vary from pain and discomfort when mobilising (e.g. in the case of a defect in a knee joint replacement) through to, in rare cases, fatalities (e.g. in the case of a defect in a heart device such as a pacemaker).

Those who manufacture medical products and devices have a responsibility and a legal duty to ensure that their products are safe for their intended use. Under the Consumer Protection Act 1987, if there is a defect in a particular device / product then the manufacturer would be automatically liable for any harm that the device / product causes whether he or she was at fault or not, subject to certain statutory defences set out in the 1987 Act. This is a concept called strict liability.

If you have been harmed or injured by what you believe may have been a defective medical product or device, then you at least deserve answers to explain what has happened. This is where Access legal could help.

I want to know

How do I make a claim about a defective medical device / product

If you believe that you have suffered injury or harm as a result of a defective medical product or device, then we would suggest that you should contact Access Legal which specialises in this sort of work as soon as is practicable to discuss your potential claim.

It is important to bear in mind, that there is a distinction between bringing a claim for injury/damage arising as a result of an inherent “defect” in medical product / device itself (i.e. a product liability claim); and bringing a claim, where for example, the product / device has malfunctioned or failed for another reason (e.g. where a surgeon has fitted a knee replacement joint negligently such that it does not work properly).

Where personal injury or death has occurred, there are strict time limits in place for making such a product liability claim; and in general this is within 3 years of the injury or death, subject to a long-stop period of 10 years from the date of supply. Because these time limits are so important and a failure to comply with these time limits could result in a loss of the right to claim we would suggest that you seek help and advice as soon as practicable.

How long will my claim about a defective medical device / product take

It is not possible to give an exact answer. 

The time taken to conclude a defective product claim will vary from case to case. Some claims, where for example the Defendant does not seek to defend the claim, may be settled relatively quickly whereas others can take years to conclude especially if they are defended. The time taken to conclude such a claim depends on its own specific facts and although it is rare, some of these cases can and do go to Trial.

In addition, it will take time for your solicitor to gather all of the necessary evidence and information required to prove your case. However this information and evidence gathering exercise is vital to allow us to properly investigate your claim and recover the proper amount of compensation to which you may be entitled as a result of the injuries that you may have suffered as a result of a defective product or device. Access Legal's experienced solicitors will advise you of the best strategy during the course of your case. We will always aim to settle your case without delay, but our priority will be to take the necessary time so as to ensure that we achieve the best possible outcome for you based on the evidence.

If I have a case about a defective product

Making any compensation claim, can be a lengthy and complex process and product liability claims are no different. For example, errors can be made by those performing the medical procedure (e.g. the surgeon may fit a pacemaker incorrectly) which may cause the device to fail or it could be inherent defects (which may not be immediately evident) in the particular type of product / device used that has caused the injury and the onus will be on you to prove which (if any) was responsible for your injuries and damage.

Product liability claims have often received wide coverage in the press, like hip resurfacing systems, such as the De Puy Orthopaedics' ASR™ system leading to their worldwide recall. The Articular Surface Replacement™ (ASR™) metal-on-metal hip system was also withdrawn by the manufacturer in 2008/early 2009.

The UK regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), issued a product recall for the DePuy ASR™ in 2012, but anyone who underwent an operation using this system since 2008 and who has experienced problems could have a case for compensation.

To make a successful product liability claim it is not sufficient to prove that a product has simply failed. It must be shown that the product / device  was less safe than you were entitled to expect it to be; and that it caused injury or harm as a result of a defect in that product or device. This can be particularly difficult in cases where the medical devices are innovative or in situations where a failure cannot be entirely prevented.

It can also be difficult to prove that the outcome would have been different if a different device had been used or if the device had worked as expected. If you have suffered injury or harm due to a defective medical device or product, then our team will work with you and guide you through this complex area of law so as to try to ensure the best possible outcome for you.

More about defective product claims

It must be remembered that in general, medical products and devices are extremely safe, and play a vital part in medicine, helping people of all ages to live healthier, happier and pain-free lives.

On the occasions that such devices are found to be defective, product liability claims can arise from the use of a wide range of medical products / devices including heart valves, pacemakers, ICD defibrillators, corneal implants and contraceptive devices.

Proving that a medical product or device is defective and that this defect has caused you harm can be an enormously complex and challenging area of law requiring specific expertise and experience. As we have said if you believe that you may have been injured by a defective medical product or device then we would suggest that you call Access Legal for a free, confidential discussion about your potential claim.

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