Manfuacturer responsibility under European Union law - prevention and prophylaxis in ECJ jurisprudence

Prevention and prophylaxis as obligations of the manufacturer under Union law: The recent jurisprudence of the European Court of Justice (ECJ) on product liability law has foregrounded prevention and prophylaxis as fundamental obligations of manufacturers under EU law. The measures necessary thereto are determined by the objectives of Union law, not national jurisprudence on legal semantics. As a consequence, a product is deemed "defective" as defined by product liability law if it belongs to a series in which defects have occurred with significant frequency and, due to its potential for damage, it can be so classified despite this product's individual defectiveness not having been established. The European Court of Justice will soon – complementary to the aforesaid – address the legal relevance of quality management systems and the liability of those responsible for them. It would not be surprising if the Court were to hold that a manufacturer's declaration of conformity, provided within the context of the organization of a certified quality management system and confirming compliance with the requirements of harmonized EU legislation and standards, constitutes "presentation" within the meaning of Section 3 of the German Product Liability Act (Article 6 of Directive 85/374/EEC). By that logic, an inaccurate declaration of conformity would meet the elements of "defect" and give rise to liability according to the German Product Liability Act.