11 June 2014: AG Szpunar in case Novo Nordisk Pharma (C-310/13)
Today, AG Szpunar issued an opinion regarding interpretation of Article 13 of the Product Liability Directive (No 85/374). Article 13 determines the scope of the Directive's application, where it should not affect any rights that an injured person may have pursuant to a national special liability system existing at the moment of this Directive's notification to the Member States.
In the given case, Ms. S, domiciled in Germany, claimed that she was injured through the use of a medicinal product (Levemir) introduced on the market by Novo Nordisk Pharma. German law excludes the application of the Directive in cases of damage to consumer's health resulting from a use of medicines, since to these cases a special system of liability applies, as established by the Arzneimittelgesetz ("AMG") prior to the implementation of the Directive in German law (Par. 84 and Par. 84a AMG). To claim compensation under this liability system the consumer may demand from the pharma company information on the known to the pharma company side effects of that medicine, potential interactions, and all other test results as well as data about consequences of using this medicine on human health, as long as this data may influence the assessment of whether the health damage resulted from the use of the medicine in the given case. Novo Nordisk Pharma refused to comply with its obligation to provide this information and appealed the need to do so. BGH asks the CJEU whether the German system of liability applicable to damage to consumer's health resulting from the use of medicines falls outside the scope of the Directive and, therefore, may be regulated independently from its provisions. Clearly, without her right to this information Mrs. S would be unlikely to prove that she suffered any damage due to her use of the medicine, since it would be hard for her to find sufficient scientific evidence. Therefore, if the CJEU would exclude the application of the AMG's provisions to this case, consumers could be devoid of necessary protection against faulty medicines.
AG Szpunar looks at the text of Article 13 and concludes that it means to allow consumers to use an alternative compensation scheme that predated the Directive. (Par. 28) However, pursuant to AG Szpunar literal interpretation of this provision points out that with regards to the special liability systems (like AMG), the Directive limits the possibility to use them only to circumstances when the rights of consumers under such special liability systems existed at the time of the Directive's implementation. It is not, therefore, the special liability system that needed to be in force prior to the Directive's implementation but consumer's entitlement to claim certain rights under this system. (Par. 30-32) Due to such interpretation, it will not be possible for one Member State (Germany) with regards to one production sector (medicine products) to differentiate and further develop a liability system. (Par. 37) This would mean that since Mrs S rights under the AMG system arose after the Directive's implementation, she could not claim her damages using AMG's provisions.
At the same time, however, AG Szpunar remarks that the duty to inform by a pharma company as established in Par. 84a AMG has not been subject to any direct regulation in the Directive. (Par. 45) If a consumer is given a right to information it will enable her to easier prove the defect in a medicine that could have contributed to the health damage. The burden of proof is regulated by Article 4 of the Directive. This Article specifies what the consumer needs to prove to claim damages in product liability cases but it does not determine the methods thereof. The consumer's right to information as established in Par. 84a AMG does not reverse the burden of proof but is only meant to alleviate it, by balancing the information asymmetry between consumers and pharma companies. (Par. 46) As unregulated by the Directive, this matter may, therefore, be left to the national law's discretion. (Par. 47) Consequently, even if Mrs S would now be forced to claim her damages under the Product Liability Directive's scheme, she should still be able to benefit from the right of information as established in Par. 84a AMG to help her prove her damage.