Faulty medical device claims

The advancement of modern medical care has been incredible.

People can now move thanks to hip replacements. Sufferers of diseases can monitor their vital signs and administer medicine as needed. Asthmatics can breathe thanks to inhalers. And other devices like bed hoists simply make life easier.

All these devices have one thing in common – before they were made available to the public they were put through rigorous testing.  

With such strict and stringent measures millions of people assume their medical devices, and indeed their own wellbeing, are safe.

But unfortunately things can go wrong. Sometimes with serious consequences.

So when you are injured by faulty medical equipment, what are your options? Here, we aim to shed light on defective medical device claims to help you understand the process, address common queries and leave you feeling assured of your options.

What is a medical device and what is classed as a defect? 

A medical device can be any instrument or appliance involved in the diagnosis, prevention, treatment, monitoring or alleviation of a disease, injury, handicap or conception. 

Medical device claims commonly associated with defective medical products include:

• Metal-on-metal hip replacements
• Contraceptive implants
• Faulty implants (including cosmetics, like those used in breast augmentations)
• Prostheses, artificial limbs and wheelchairs 
• Disease management devices such as inhalers, epi-pens etc
• Oculentis implants     
• Pacemakers 

A device may be deemed defective if it failed to work as intended then caused injury to the user and a defect can be anything that does not conform to specification. It could also be that the ordinary risks of using the device turn out to be statistically much greater than for alternative devices available at the time you received yours. 

Mechanical components fail over time. Software can become dated and malfunction. Improper maintenance can cause failures. And some devices cause adverse reactions to the user. 

What to do after being injured by a defective medical product

In the immediate aftermath of an injury many people may need a medical professional to help treat their wounds. Your physical and mental wellbeing should always be the first priority.

We also recommend you do NOT immediately contact the maker or provider of the device for one very good reason:

A key piece of evidence in any defective product claim is the product itself.

If you raise the alarm then 99% of the time you will be asked to return it. If the fault relates to a medical device that was surgically implanted then the maker of the device may arrange for an operation to remove it. 

Sometimes when a manufacturer of a medical device has agreed to provide a free operation to resolve the issue it may only be carried out on the condition that you also waive your right to any future legal action. This is why it’s important to seek expert legal advice BEFORE making any decisions on your next steps. 

As returning an item can result in potential hurdles we recommend people retain or search for other key pieces of evidence that can help with an injury claim:

• Proof of purchase – either a receipt or email. In many cases an operation to implant a device or provision of the device will take place through the NHS. We will need the details of your GP and any hospital involved  so that we can obtain product labels from your records 
• If an operation is carried out privately then the details of the hospital or treatment centre used  and details of the payment method (eg credit card)
• Photograph and write down any unique ID markings like serial, warranty, batch or license numbers; barcodes or QR codes; other identifying marks
• Any readings from digital displays 
• Images or footage that clearly illustrates the fault during (attempted) intended use
• Have a look for any original packaging, manuals or instructions (including any email updates that may have come from the maker/provider following online warranty activation)

Don’t worry if you’ve already returned the item before speaking to us – it’s not the end of the world and a claim is still possible. A solicitor will be able to review the circumstances of your case and give you the right legal advice.

Defective medical product claims process

Generally speaking, the legal process around defective medical product claims is similar to that of any other claim.

First we gather evidence relating to the issue. Then we assess your injuries and the impact they have on your life. Then we calculate your financial losses such as lost earnings or incurred expenses. And finally we seek to recover your losses from the liable party in the form of a compensation claim.

For this approach to be successful we have to prove two things: 

1. The medical device was faulty
2. That fault then caused your injury 

We do this by gathering the right evidence, working with the right experts and applying the right laws and regulations. 

We will carry out a comparison with the performance of other medical devices or treatment methods available at the time your received your medical device. Being able to achieve this is possible due to our no win, no fee funding model.

The Consumer Protection Act 1987 is the key piece of legislation that protects people. It makes clear that the manufacturers of any product have a legal duty to ensure their goods are safe for intended use. If they are not then those manufacturers may be held strictly liable – and victims of injury are entitled to recover compensation.  

But as simple as it seems it is no easy task as many things can impact a product liability case.

Faulty medical devices from foreign manufacturers

Medical devices are frequently made outside of the UK. This means dealing with foreign manufacturers. 

Different countries also have different levels of safe certification for different devices so understanding foreign regulations (which often differ from that of the UK or Scotland) is of paramount importance. 

Then, in addition to all that, there is the need to effectively navigate foreign legal processes in case there is a need to raise a legal action in a foreign court. 

Thankfully Mark Gibson, the head of our Product Liability team, is also the head of our Foreign & Travel department. His expertise combined with the team’s global reputation and network of contacts, it means we can confidently say your medical compensation claim is in the best possible hands.

Defective medicines and incorrect prescriptions

Similar considerations apply when someone is injured due to a medicine or drug prescribed by their healthcare provider. Digby Brown has many years of experience distinguishing the common and accepted side effects of the drug or medicine with risks that have not been accepted by the patient. 

Furthermore, side effects listed in the warnings that accompany the medication may not be acceptable if they arise substantially more frequently than with equivalent medications that could have been described and which also treat the condition effectively. 

In extreme cases, we have seen patients receive the wrong medication from their healthcare provider or pharmacy. In such cases, there is nothing wrong with the product but they have simply been given to the wrong patient who may react to their injury or simply obtain no therapeutic benefit. In such cases the pharmacy or healthcare provider may be professionally negligent.

At Digby Brown, our defective medical product team are able to work in partnership with our clinical and professional negligence teams to establish whether the product was defective or whether it was simply provided to someone it was not suitable for. 

Do class actions happen in Scotland?

While such circumstances are rare, many people can experience the same injury as a result of the same defective product.

Recent changes to the law in Scotland mean that it is possible to raise a “so-called” class action where one single claim is raised on behalf of multiple people in relation to a common issue. 

Alternatively, multiple cases can be raised in Court at the same time and the Court would be asked to select a “test case” to answer legal questions common to all the cases. The product team at Digby Brown has vast experience in raising group actions in relation to all types of medical and consumer products.

However as your case may require the need to act in a foreign court it could be possible for you to join a class action if that foreign court allows. We have the legal expertise to let you know if this is a viable option for you. 

How to report faulty medicine or defective medical equipment 

The integrity of medical devices and the monitoring of their safety for public use is chiefly overseen in UK by the Medicines & Healthcare products Regulatory Agency. If you have any concerns about a device then you can contact the MHRA directly:

Email: aic@mhra.gov.uk

Call: 020 3080 7080

Online: Report problem with medicine or medical devices