Overview
- The Federal Court of Justice heard a case brought by Pia Aksoy, who alleges she suffered hearing loss three days after a March 5, 2021 Vaxzevria shot, seeking at least €150,000 and access to AstraZeneca’s data.
- Lower courts in Mainz and Koblenz rejected her claims, pointing to EU regulators’ finding of a positive benefit–risk balance and deeming the product information sufficient.
- At the hearing, presiding judge Stephan Seiters questioned the Koblenz court’s refusal of an information claim, stressing that plausibility of a causal link can suffice, and the panel noted a possible referral to the European Court of Justice.
- Under Germany’s Medicines Act, manufacturers face liability only if harmful effects exceed what is scientifically justifiable or if labeling failed to reflect the state of knowledge at the time.
- Vaxzevria’s EU authorization was withdrawn in 2024, PEI logged roughly 350,000 suspected adverse-reaction reports without proving causation, and a rarely cited procurement regulation could bar claims, though courts have not applied it.