BodyTech - a new wave of medical devices product liability litigation?
Summary
Medical devices cover an enormous range of products from plasters you can buy from a pharmacy or supermarket to cardiac pacemakers and MRI scanners. The EUs current product liability regime dates from 1985, and concerns have been raised that it is no longer fit for purpose, particularly in the context of technological advancements. Multiple defendants – does liability lie with the medical devices manufacturer, designer of the system, software or network provider, user (patient or hospital) or even a third party hacker? If a claimant alleges that they have become incapacitated as a result of an injury, is the data on their fitness tracking device showing their activity levels discloseable in litigation? The existing regime is undergoing a significant upheaval with the introduction of two new EU Regulations which will increase the responsibilities of manufacturers and brings a new classification rule applicable to software.