Luxembourg, 30/05/2005 (Agence Europe) - Following a hearing in the Declan O'Byrne case against the company Aventis Pasteur over the company's liability for an anti-haemophilia vaccine that the child's family claims was defective and led to serious brain damage, Advocate General Geelhoed is expected to publish his conclusions on 2 June. The case revolves around the exact date the product was put into circulation and whether this falls outside the ten-year period for bringing an action against the manufacturer for strict liability for the product. A European directive of 1985 establishes 'liability without fault' whereby it is sufficient to prove that damage was caused by the defective product without the alleged victims having to find out where the fault lies in the manufacture of the product in question.
On 18 September 1992, Pasteur Merieux Serums et Vaccins, which subsequently changed its name to Aventis Pasteur SA (APSA), sent a consignment of units of the vaccine, including that administered to the victim, to Merieux UK, which subsequently changed its name to Aventis Pasteur MSD (APMSD), a wholly-owned subsidiary of APSA that acted as a distributor in the UK of products manufactured by APSA. On an unknown date after 7 October 1992, part of the consignment appears to have been sold by APMSD to the Department of Health of the UK and supplied directly to a hospital, which in turn supplied it to the surgery where the victim was vaccinated on 3 November 1992. On 2 November 2000, the victim brought proceedings for compensation against APMSD, claiming it was the producer of the product, bringing a second action on 7 October 2002 against APSA since it was not until the summer of 2002 that it became clear to the victim's family that the producer of the product was in fact APSA, and not APMSD, its distributor in the UK. In the second proceedings, APSA contended that since it had placed the product on the market by consignment to its subsidiary on 18 September 1992, which received it on 22 September 1992, the action brought on 7 October 2002 was commenced after the expiry date of the period for bringing an action (ten years from the date when the product was put into circulation). The child's lawyer, the British government and the European Commission responded that putting a vaccine into circulation involves the manufacturer 'losing control' of its product, i.e. transferring it to a person or institution over which the manufacturer has no authority, namely the hospital, which happened after 7 October 1992. They claim that this means the case against APSA was indeed brought within the ten year time period.
The High Court of Justice in the UK requested that the European Court of Justice interpret Article 11 of the 1985 European directive which stipulates that the right to take manufacturers to court expires ten years after the date when the product is put into circulation, unless victims launch judicial proceedings during this ten year period.
Another issue to be settled by the European Court of Justice is the fact that the Commission claims the 1985 directive allows national courts (the High Court of Justice in this case) to decide that action brought against a distributor is the equivalent of action against the manufacturer if the distributor (APMSD) knew that the manufacturer was its parent company and APMSD could have informed the victim's family of this within a reasonable time period, in any event, before the expiry of the ten year period. Advocate General Geelhoed will review the matter on Thursday.