FIRST PRODUCT LIABILITY CASE BROUGHT BEFORE THE EUROPEAN COURT
Court decision-update
By: Yvonne Halpaus - QNET LLC
Case C-203/99, Henning Veedfald vs. Arhus Regional Authority concerns a Danish patient who was intended to receive a kidney transplant donated by his brother during an operation that was publicly funded.
The kidney was removed from the brother and preserved pending implant in fluid made by another public hospital within the same authority. (Placing the fluid on the market?)
Before the implant it was noticed that the fluid contained microscropic crystals that, after the kidney had been implanted, would have made the kidney unviable and would have clogged the patient's arteries. The kidney could not be implanted.
The patient has filed a claim against the regional authority responsible for both the manufacture of the fluid and the explant of the kidney.
The Official Journal of the European Community reported that the following questions were submitted by the Danish Supreme Court to the Court of Justice of the European Communities, for a preliminary ruling:
(All questions refer to the: "The European Council Directive 85/374/EEC of July 25th 1985 on the approximation of the laws, regulations and administrative provisions of the Member States concerning liability for defective products".)
Question 1
Must article 7(a) of the directive be construed as meaning that a defective product is not put into circulation if the producer of the defective product, in the course of providing a specific medical service, produces and uses the product on a human organ which, at the time when the damage occurred, had been removed from a donor's body in order to be prepared for transplant into another person's body, with resulting damage to the organ?
Judgment of the Court:
The answer to be given to the first question must accordingly be that Article 7 (a) of the Directive is to be interpreted as meaning that a defective product is put into circulation when it is used during the provision of a specific medical service, consisting in preparing a human organ for transplantation, and the damage caused to the organ results from that preparatory treatment.
Question 2
Must article 7 (c) of the directive be construed as meaning that a publicly owned hospital is free from liability under the directive for products produced and used by that hospital in the course of providing a specific publicly financed service to the person suffering injury and in respect of which that person has not paid any consideration?
Does Community Law impose requirements as to how Member States should define the expressions 'damage caused by death or by personal injuries' and 'damage to, or destruction of, any item of property' in article 9 of the directive, or are individual Member States free to decide what meaning is to be attached to those expressions?
Judgment of the Court:
The answer to be given to the third question must therefore be that Article 9 of the Directive is to be interpreted as meaning that, save for non-material damage whose reparation is governed solely by National law and the exclusions detailed in that article as regards damage to an item of property, a member State may not restrict the types of material damage, resulting from death or from personal injury, or from damage to or destruction of an item of property, which are to be made good.
Question 4
Must article 9(a) of the directive be construed as meaning that damage to a human organ which, at the time when the damage occurred, had been removed from a donor's body for immediate transplant into certain other person's body is covered by the expression 'damage caused by … personal injuries' in relation to the intended recipient of the organ?
Question 5
Must article 9 (b) of the directive be construed as meaning that damage to a human organ which, at the time when the damage was occasioned, had been removed from a donor's body for immediate transplant into certain other person's body is covered by the expression ' damage to, or destruction of, any item of property' in relation to the intended recipient of the organ?
Judgment of the Court (questions 4+5)
The national (Denmark) court is required, under Directive 85/374, to examine under which head the circumstances of the case are to be categorized, namely whether the case concerns damage covered by point (a) or by point (b) of the first paragraph of Article 9 or non-material damage which may possibly be covered by national law. The national court may, however, not decline to award any damages at all under the Directive on the ground that, where the other conditions of liability are fulfilled, the damage incurred is not such as to fall under any of the foregoing heads.