A European Perspective #1 | GERMANY
The Frankfurt Regional Court confirmed: The reduced burden of proof under Section 84(2) AMG does not apply for investigational medicinal products, leaving plaintiffs to prove causation under the strict standard of Section 286 ZPO. The decision further strengthens sponsors’ position by confirming that risk disclosure is the investigator’s responsibility.
The Case at Stake: Between 2013 and 2015, the plaintiff participated in an industry-sponsored, placebo-controlled clinical trial with an investigational drug that had not yet been approved. In 2015, he suffered a severe infection with brain abscess and permanent neurological damage. He claimed damages from the insurer and the sponsor of the clinical trial for, among others, pain and suffering, loss of earnings, and household management damages. He attributed the damages to the investigational medicinal product (IMP) and also complained of insufficient risk disclosure.
The Decision: The regional court dismissed the action in its entirety. In the court's view, the decisive factor was the lack of causality between the IMP and the damage to health that would give rise to liability. According to the general rules, the burden of proof for causality between the IMP and the damage that would give rise to liability lies with the plaintiff. Although an immunomodulatory effect of the active ingredient could not be ruled out, a definite causal link could not be established. The expert commissioned by the regional court of Frankfurt am Main considered a contributory cause to be merely possible, which was not sufficient for full proof under Section 286 of the German Code of Civil Procedure (ZPO). The court also emphasized that the reduced burden of proof under Section 84 (2) of the German Medicines Act (AMG) did not apply to investigational medicinal products, as it only applies to medicinal products subject to approval (but not for IMPs). An analogous application was also out of the question due to the independent statutory allocation of risk in the clinical trial stage. Prima facie evidence was also ruled out due to a lack of typicality; the plaintiff's predispositions (obesity, nicotine consumption, autoimmune disease) could be considered as independent causes. With regard to risk disclosure, the court clarified that this obligation applies exclusively to the principal investigator; delegation or attribution of knowledge to the sponsor (Section 278 BGB) is not possible.
This is important for sponsors of clinical trials:
The ruling by the Frankfurt am Main Regional Court strengthens the legal position of sponsors: The reduced burden of proof (presumption of causality) under Section 84(2) of the German Medicines Act (AMG) does not apply to a (in this case: unapproved) investigational medicinal product. The strict requirement of full proof under Section 286 of the German Code of Civil Procedure (ZPO) remains decisive.
In addition, the Regional Court confirms that the sponsor is not responsible for informing the trial participant of the risks, but rather the investigator; attribution of knowledge or liability is excluded. For liability cases, clear documentation of risk distribution in the study context is therefore crucial: If a sponsor provides the trial sites/investigators with an ICF template for use, the CTA must stipulate that its use does not release the investigator from his/her obligation to properly and fully inform the trial participants.
