EU court rules on no-fault liability for medical services with medical devices

The judgment in the Centre hospitalier universitaire de Besançon v Thomas Dutrueux, Caisse primaire d’assurance maladie du Jura case that I wrote about earlier has been handed down by the EU Court on 21 December and as expected, the EU Court followed its Advocate General. For a summary of facts and the judgment, see the EU Court’s press release.

As expected the EU court makes a very clear distinction between the field of no-fault product liability under EU directive 85/374, the product liability directive, and other sources of no-fault and fault-based liability and finds that no-fault liability for medical services involving defective medical devices is not precluded by the EU product liability directive, provided that such liability does not adversely affect the useful effect of the product liability directive. In the words of the EU Court:

it must remain possible for the producer’s liability to be put in issue when the conditions for such liability to exist are fulfilled. The service provider must therefore also be able to use a legal mechanism – such as that of bringing third-party proceedings as provided for by [national] legislation – allowing the producer’s liability to be put in issue.

The EU Court explicitly states that additional recourse for the consumer against the medical treatment provider in the form of no-fault liability for medical services involving a defective medical device is a welcome addition to no-fault product liability as it can contribute to enhancing consumer protection.

From a patient perspective and from a manufacturer’s perspective this development is to be welcomed, as it will prompt medical treatment providers to manage risks with respect to medical devices better. They may become more vigilant in detecting defects in device (whether or not those a manufacturing defects or defects caused by hospital use or adaptation) that otherwise might have been used on patients. Such risk management sometimes leaves a lot to be desired and can be complicated, especially when it involves implementation of software or networked medical devices in the hospital’s infrastructure.

Other solutions than no-fault liability for medical services are also possible: hospitals in the Netherlands have recently signed the Convenant Medische Technologie (Agreement Medical Technology), in which each hospital agrees to implement appropriate life cycle management systems under the direct responsibility of the hospital board. The report “Medische Technologie at Risk?” (“Medical Technology At Risk?”) identifies a number of areas where hospitals and medical devices producers could cooperate to reduce patient risk, e.g. in usability engineering and standardization of connections/interfaces of devices. Such cooperation would clearly fit in better risk management for the benefit of patients, as improvements to usability of devices are both part of the hospitals’ obligations to patients and of manufacturers’ clinical evaluation of their devices.


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