During proceedings instituted incorrectly against the supplier of a defective product, the producer can be substituted for him only within a period of 10 years from the putting into circulation of the product, according to a Council directive. However, it has been ruled by the European Court that a substitution is possible after the expiry of this period where the supplier is wholly-owned by the producer.
The European Court of Justice has highlighted an exception to the directive of the 10 year expiry period, following an action brought about by a victim of a defective vaccine.
The French company Aventis Pasteur SA (APSA) produces pharmaceutical products, including an antihaemophilus vaccine. Mérieux UK Ltd, a wholly-owned subsidiary of APSA acting as distributor in the United Kingdom, sold a consignment of vaccine units to the United Kingdom Department of Health for the purposes of a hospital which in turn supplied part of those units of vaccine to a medical surgery.
Subsequent to the administration of a unit of the vaccine at issue, a patient suffered from severe brain damage. He brought, initially, an action for damages, within the 10-year period, against the United Kingdom subsidiary Mérieux UK Ltd, now Aventis Pasteur MSD (APMSD).
The patient applied for an order that APSA be substituted for APMSD by arguing that, at the time of bringing the action, he wrongly believed that the manufacturer of the vaccine at issue was APMSD. However, due to the application for substitution being made outside of the of the 10-year expiry period, the existing directive rendered his request for substitution invalid.
In response, the European Court determined that a producer can be substituted for its subsidiary outside of the 10 year expiry period, on condition that the putting into circulation of the product in question was determined by that producer.
European court of Justice – Justice and Application – full texts
