PhD student: Mrs A.E.M. Verjans

Promotors: Mrs Prof S. Stijns, Prof H.L. Nys, Mrs Prof I. Samoy

Duration: 1/6/2012 - 30/9/2016

PhD defence: Leuven, 23/10/2018

Abstract:

This project aims to address the specific issues that arise concerning liability for implantable medical devices. Patients who have been injured by (defective) implantable medical devices experience a lot of difficulties when attempting to recover damages. Several parties are involved in the chain of distribution and the implantation of the injury-causing device: the hospital, the manufacturer, the distributor, the doctor, the patient, the representative of the manufacturer, In addition, the applicable rules are highly fragmented and a heavy burden of proof is placed on the victim. Therefore, we will examine which (product) liability regimes are applicable and we will determine who can be held responsible for the injury. Furthermore, we will address several issues concerning liability for medical devices, among which the obligation to inform the patient, the burden of proof, the (juridical) role of medical device company representatives, product recall.

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