Pharmaceutical products have been in the spotlight of the Council of the European Union’s Product Liability Directive since its adoption in 1985. Despite the amount of time that has passed, some legal uncertainties remain that strike directly at the notion of defectiveness, as well as the causal link between the defect and the damage (which proved to be even more important in the case of pharmaceutical products). Establishing such causal link in cases involving vaccines is notoriously difficult, especially from the perspective of a lay consumer. This has led some EU member states, such as France, to introduce case law aimed at facilitating the burden of proof in specific sectors.
The European Court of Justice has, for example in the Novo Nordisk Pharma GmbH v. S case, limited such potential circumventions of the Product Liability Directive by allowing only those alternative systems that existed prior to the Product Liability Directive. Such a distinction seems to be especially important for Slovenia and Croatia, as both introduced product liability into their legal systems even before the introduction of the Product Liability Directive.
National legislators in these countries, however, did not take the additional step of facilitating the burden of proof, which, pursuant to the Product Liability Directive, lies with the consumer. The European Court of Justice held in several landmark cases that the nature of the Product Liability Directive is in full harmonization with national legal systems, preventing the shift of the burden of proof away from the consumer to the producer of a specific product.
One relatively recent decision by the European Court of Justice, Boston Scientific Medizintechnik GmbH v. AOK Sachsen-Anhalt, has led some commentators to conclude that the Court is apparently relativizing its strict position regarding the burden of proof by widening the notion of the defect. Pursuant to the Product Liability Directive, a product is defective when it does not provide the degree of safety which a person is entitled to expect. This has generally been interpreted to mean that the plaintiff must prove that a specific product had a defect, which caused damage. In the Boston Scientific Medizintechnik case, however, the Court held that, if an entire series of products suffers from a defect that increases the risk of damage, there is no need to establish a defect in each individual product pertaining to the same batch. Such reasoning has important consequences for pharmaceutical products as well, since they are generally produced in batches.
However, the most recent case law of the European Court of Justice from 2017 does not support the trend of facilitating the consumer’s burden of proof. In this case, a person developed symptoms of multiple sclerosis shortly after being vaccinated against hepatitis B. Following his death in 2011, members of his family brought an action for damages against Sanofi Pasteur, which was the manufacturer of the vaccine. Following the initial success of the plaintiffs, and the subsequent overturning of the decision by an appellate court, the plaintiffs relied on the case law of the French Court of Cassation, according to which the proof of a causal link in the case of pharmaceutical products between the defect and the damage can be derived from serious, specific, and consistent presumptions.
The question for the European Court of Justice was, therefore, whether such presumptions under national case law for pharmaceutical products are in line with the Product Liability Directive’s burden of proof, which lies with the consumer. Importantly, the court observed that even if the ambition of the Product Liability Directive is full harmonization, the directive itself does not regulate all matters. For example, procedural aspects, including evidentiary rules, are governed by national legislation, which is bound by the principle of effectiveness. Therefore, national legal systems cannot undermine the total effectiveness of the system of liability introduced by the Product Liability Directive.
The court held that only rebuttable presumptions which are based on factual evidence constitute serious, specific, and consistent evidence that there is a defect and a causal link between the defect and the disease. Importantly, the Product Liability Directive precludes evidentiary rules according to which a causal link is proved if medical research neither establishes nor rules out the existence of such a link, and only certain predetermined causation-related factual evidence is presented.
Recent case law in product liability confirms that plaintiffs cannot succeed by relying on national evidentiary rules that effectively result in the reversal of the burden of proof. Considering strong objections from the professional public, it remains to be seen whether the anticipated reform of the Product Liability Directive will bring any changes to these issues.
By Igor Angelovski, Partner / Independent Attorney at Law in cooperation with Karanovic & Partners
This Article was originally published in Issue 6.6 of the CEE Legal Matters Magazine. If you would like to receive a hard copy of the magazine, you can subscribe here.