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Germany’s Top Court Orders Rehearing in AstraZeneca Vaccine Case, Lowers Bar for Data Access

The ruling clarifies that a plausible causal link can trigger a manufacturer’s duty to disclose internal safety information.

Overview

  • The Federal Court of Justice set aside parts of an OLG Koblenz ruling and sent the case back for a new hearing.
  • The judges said the lower court applied excessively strict standards to the plaintiff’s right to information, finding plausibility of causation can suffice even if contrary evidence is stronger.
  • The court did not decide whether the AstraZeneca shot caused the claimant’s hearing loss, but it directed the lower court to reassess potential damages under the corrected standard.
  • The plaintiff, dentist Pia Aksoy, reports complete hearing loss in one ear three days after a March 2021 Vaxzevria dose and seeks at least €150,000 plus detailed company-held data.
  • Earlier courts leaned on the EMA’s positive benefit–risk assessment of the vaccine; PEI figures note roughly 350,000 suspected reports through 2024 are temporal associations rather than confirmed causal reactions.