• 作者：Alain Gorny ; ^{agorny@lexcase.com} (Avocat associ&eacute ; ) ; Agnè ; s Lerolle ^{agnes.lerolle@gmail.com} (Juriste)
• 关键词：Question pr&eacute ; judicielle ; Dispositif m&eacute ; dical (responsabilit&eacute ; du fabricant) ; Produits d&eacute ; fectueux (responsabilit&eacute ; ) ; Fournisseur (responsabilit&eacute ; ) ; Hô ; pital (responsabilit&eacute ; )
• 刊名：Medecine et Droit
• 出版年：2012
• 期刊代码：194_12467391
• 类别：med
• 出版时间：May-June, 2012
• 卷：2012
• 期：114
• 页码：67-75
• 文件大小：356 K

Who聽鈥斅爃ospital or manufacturer?聽鈥斅爄s liable to compensate no-fault damage caused by defect in a medical device used in a hospital, or supplied by it to a patient? Rulings handed down over almost six years by the Conseil d鈥櫭塼at (Council of State) and by the Administrative Courts of Appeal of Bordeaux and Nancy initially upheld the liability of the hospitals as 鈥渦sers鈥?or 鈥渙r suppliers鈥?of medical devices where they were defective. The Lyon Administrative Court of Appeal then opposed this reasoning, applying EEC directive 85/371聽of 25聽July 1985聽relating to defective products. In this context of contradictory case-law, the Conseil d鈥櫭塼at, to which the issue was referred, made a referral to the ECJ (European Court of Justice) on 4th October 2010, posing a double preliminary question as to whether the 1985聽directive authorises specific independent rules regarding user liability for a defective product. The main issue rests in the difficulty of distinguishing between: the defective product rules arising from EEC directive 85/371; the judicial rules on no-fault liability of public health institutions as established by the Marzouk ruling (EC, 9th July 2003), and Article L.聽1142-1-I of the Public Health Code, which poses, in principle, that the liability of health institutions (public or private) may only be upheld in cases of wrongdoing or due to a defect in a health product. To this issue of distinction should be added the question of the respective definitions of 鈥渟upplied鈥?equipment and 鈥渦sed鈥?equipment. By decision issued on 21st December 2011, the ECJ ruled that the member States may organize a regime of liability specific to the public hospitals due to the defective nature of the devices that they used in the course of healthcare services provided to patients. The decision of the ECJ also gives rise to the opportunity to look at the arguments in defence which may be used by manufacturers and health institutions depending on whether they have only used the devices or also provided them to the patient. This specific regime is an alternative to the regime arising from the directive: patients may, at their choice, either sue the hospital on the ground of the no-fault liability or sue the manufacturer on that of the directive. The ECJ ruling keeps silent on the liability of the hospital that supplies the device to the patient (ortheses, implantable devices like prostheses). Only the directive regime should apply to this situation.