The recent ruling emphasizes the important role of judicial review in assessing the benefit-risk balance of medicines. Despite regulatory approval, this does not preclude the court from independently reviewing the benefit-risk balance. This decision reinforces the legal clarification that the approval of a drug does not automatically exclude the manufacturer's liability, especially when new findings subsequently emerge.
Judgment of the Itzehoe Regional Court
(aa) The approval of a medicinal product or vaccine by the competent authorities does not preclude judicial review as to whether a negative benefit-risk balance is to be assumed. According to Section 25 (2) No. 5 AMG, the competent authority may refuse approval if, among other things, the benefit-risk ratio of the medicinal product is unfavorable. However, the assessment of this question within the framework of the approval procedure is subject to full judicial review; in this respect, the authority has no independent discretion (Kügel et al./Kügel, 3rd ed., Section 25 AMG marginal no. 69). Furthermore, Section 25 (10 AMG) stipulates that the granted approval "does not affect the civil and criminal liability of the pharmaceutical entrepreneur." This means that, in principle, the company cannot exculpate itself by arguing that pharmaceutical damage was caused by an approved preparation (Erbs/Kohlhaas/Pfohl, Ancillary Criminal Laws, 254th Edition October 2024, Section 25 AMG, marginal no. 2; Weber/Kornprobst/Maier/Weber, Narcotics Act, 6th Edition, Section 25 AMG, marginal no. 9). The approval of a medicinal product generally has no excluding or justifying effect (Erbs/Kohlhaas/Pfohl, 254th Edition October 2024, Section 25 AMG, marginal no. 4).
(bb) However, according to the opinion predominant in the literature, when examining a claim under Section 84 AMG, marketing authorisation is a “significant indication” of a positive benefit-risk balance (Kügel et al./Brock, Section 84 AMG, marginal no. 85; cf. also Bergmann et al./Brixius, Gesamtes Medizinrecht, 4th ed., Section 84 AMG, marginal no. 6) and thus of an exclusion of liability under Section 84, paragraph 1, sentence 2, no. 1 AMG. And according to an opinion held in some case law, the positive benefit-risk balance should even be established with the marketing authorisation of a medicinal product (OLG Koblenz, judgment of 10 July 2024 – 5 U 1375/23, 2nd guiding principle, cited according to juris).
In the Chamber's opinion, the latter view, in particular, is too far-reaching. It is inconsistent with the provision of Section 25 (10) of the AMG, according to which the marketing authorization leaves the pharmaceutical company's civil and criminal liability unaffected and is not intended to limit it, and the assessment of the benefit-risk balance within the framework of the marketing authorization procedure is subject to full judicial review (see Kügel et al./Kügel, 3rd ed., Section 25 AMG, marginal no. 69). Furthermore, it should be considered that – as already explained above – the question of the benefit-risk balance is correctly assessed based on the time of the last oral hearing, and the findings available at that time must be projected back to the time the medicinal product was placed on the market (cf. Schleswig Higher Regional Court, judgment of December 20, 2013 – 4 U 121/11 – Juris, marginal no. 45). However, the decision to approve a medicinal product may not have taken into account further findings that emerged later. Therefore, the approval of a medicinal product alone cannot be used to conclude that the benefit-risk balance is positive, since the further findings that only became known later, after the medicinal product's approval and marketing, up until the oral hearing in the liability proceedings would be ignored.
However, even if one fundamentally follows the opposing view and assumes a positive benefit-risk balance due to the approval, the prospects of success for a claim under Section 84 (1) AMG cannot be denied in the present case. This is because this view, which is particularly advocated by the Koblenz Higher Regional Court, is not established higher court case law. Of the higher courts, the Koblenz Higher Regional Court is the only one to have taken the view that the approval of a medicinal product also establishes its positive benefit-risk balance. While this view is also held by numerous regional courts, other higher regional courts and in particular the Federal Court of Justice have not yet – as far as can be seen – ruled on this issue. However, if there is no established (higher court) case law on a legal issue such as the one presented above, the prospects of success for a claim for damages cannot be denied in the context of proceedings aimed at providing coverage. Rather, this legal question must then be clarified in the main proceedings, in this case the reference proceedings (cf. BGH, judgment of 20 April 1994 – IV ZR 209/92 – cited according to Juris at para. 14; Piontek, in: Prölss/Martin, VVG, 35th ed. § 1 ARB 2010 para. 9).
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Conclusion
Overall, the ruling underscores the need for thorough judicial review in connection with the approval and marketing of medicinal products. It emphasizes that a positive benefit-risk balance is not proven by the approval alone, especially when new information subsequently emerges. This clarification contributes to legal certainty and underscores the importance of comprehensive judicial review in liability cases pursuant to Section 84 of the German Medicines Act (AMG).
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