When they work properly, pacemakers can be lifesaving and have the potential to significantly improve quality of life even for those who are not at immediate risk of death.
Unfortunately, however, there have been a growing number of stories recently about people fitted with faulty pacemakers, which can have very serious health consequences, including the potential to be fatal for those with serious health conditions.
If you or a loved one have suffered harm to your health as a result of being fitted with a faulty pacemaker, you may be able to claim compensation depending on the circumstances. The manufacturer or retailer of the pacemaker (or anyone else involved in the production, distribution and sale of the device) may be legally responsible for the consequences of a faulty device. This could be grounds for a claim.
Who is liable for a faulty pacemaker?
This will depend on the circumstances. If the pacemaker was manufactured in the EU, you may be able to make a claim against the manufacturer or the retailer of the device. If the pacemaker was produced outside of the EU, you may be able to claim against the importer or the retailer.
It is also possible that others involved in the production, distribution and sale of the pacemaker may hold some degree of legal responsibility for the device, depending on the situation.
How have unsafe pacemakers ended up in use?
Under current EU rules, there is no single organization responsible for certifying medical devices as safe for use within the European Economic Area (EEA). Instead there are 58 different companies, known as ‘notified bodies’, who are allowed to issue CE marks approving medical devices for use in Europe.
This has resulted in varying standards between organizations for what is considered “safe”. Manufacturers, importers and retailers of medical devices are able to apply to as many of these organisations as they wish to try to secure a CE mark, meaning that even if a device is not considered safe by one notified body, companies seeking certification can simply keep trying other notified bodies until they get the result they need.
This scandal was uncovered as part of an investigation led by the International Consortium of Investigative Journalists, working in partnership with 59 media organisations around the world, including BBC Panorama, The Guardian and the British Medical Journal.
How to claim compensation for a faulty pacemaker
If you or a loved one have been harmed by a faulty pacemaker, having expert legal guidance is essential to give you the best chance of securing fair compensation. Many claims can be resolved out of court, through negotiation and Alternative Dispute Resolution (ADR), but court action may sometimes be required to achieve the right outcome for your interests.
Medical equipment failure claims can be complicated and contentious due to the high value of the potential compensation involved, so it is important to work with specialists with specific experience in these types of claims. That way you can be confident that all of the right details will be identified and considered, and no potential angle will be overlooked.