Pia Aksoy lost her hearing. After an AstraZeneca vaccination in March 2021, experts diagnosed a likely irreversible unilateral hearing loss. The occupational insurance recognized the vaccine injury. But the courts? Two instances dismissed her lawsuit. She had to go all the way to Germany’s Federal Court of Justice (BGH).
“My hearing was taken from me. And I had to go to the BGH to be granted a legal hearing,” Aksoy said after the verdict.
On March 9, 2026, the BGH’s VI Civil Senate ruled in her favor — and in doing so, dismantled the entire dismissal logic used by lower courts (Case No. VI ZR 335/24).
What the BGH Decided #
1. Right to Information: Plausibility Suffices #
Until now, courts required vaccine-injured plaintiffs to nearly prove the connection between vaccination and injury — before they could even obtain information from the manufacturer. A vicious circle: no data, no proof; no proof, no data.
The BGH now states unequivocally: Plausibility is enough. Not preponderance of probability. The right to information under §84a of the German Medicines Act (AMG) can exist even when, at an early stage, more speaks against than for causation.
“That is legally erroneous,” said Presiding Judge Stephan Seiters regarding the narrow interpretation by the Higher Regional Court of Koblenz.
2. Comprehensive Right to Information #
The Koblenz court had ruled that the right to information applied only to the plaintiff’s specific medical condition. The BGH disagrees: the right extends to all effects, side effects, suspected cases, and other findings known to the manufacturer.
Why? Because the injured party must demonstrate a generally negative risk-benefit ratio — and for that, they need all the data, not just data relating to their own symptoms.
3. Information and Damages Are Interlinked #
Whoever wrongly cuts off the right to information often simultaneously cuts off the damages assessment. The BGH clarified: §84a AMG and §84 AMG are substantively interlinked. The entire appellate judgment suffered from legal errors because it had wrongly denied the right to information.
4. Approval Is Not Acquittal #
The manufacturers’ standard defense strategy: “The EMA approved it, so the risk-benefit ratio is positive.” The BGH puts a big question mark on this argument.
Article 15 of EU Regulation (EC) No. 726/2004 explicitly states: the granting of authorization leaves the civil liability of the manufacturer unaffected. And Article 17 adds: the authorization holder is personally responsible for the accuracy of submitted documents.
Approval is a regulatory interim status — not an acquittal in civil proceedings.
5. Authority Assessments Don’t Replace Expert Opinions #
PRAC, CHMP, EMA, PEI — the assessments of these bodies may not be used as “black-box evidence” when the underlying data is not disclosed. Official reports can only exceptionally replace a requested expert opinion.
6. “Idiopathic” Is Not an Argument #
The diagnosis “without identifiable cause” (idiopathic) is neither a knockout argument against plausibility nor a concrete alternative cause. Until now, this was exactly the standard defense in many proceedings.
7. Risk-Benefit Is Assessed Currently #
The risk-benefit assessment is not frozen at the time of approval. It must be reviewed according to the scientific state of knowledge at the last oral hearing — meaning current knowledge, not the knowledge of 2020/2021.
What This Means for Ongoing Cases #
The Previous Dismissal Formulas Are Dead #
Lower courts have dismissed vaccine injury cases using a predictable pattern:
- ❌ “No information if the main claim doesn’t exist” — demolished
- ❌ “Information limited to own injuries only” — demolished
- ❌ “Positive risk-benefit ratio automatically follows from approval” — demolished
- ❌ “Deny causation if no patient records” — demolished
- ❌ “Judge can make medical assessment themselves” — demolished
The BGH did not directly impose liability on manufacturers. But it removed their most convenient shields.
Over 400 Rulings May Be Unlawful #
Numerous previously used dismissal formulas are no longer the state of the law since March 9, 2026. Insofar as the Higher Regional Courts of Frankfurt and Koblenz worked with exactly this pattern — and the BGH explicitly references them — this shortcut is now branded as “legally untenable” by the highest court.
The Failure of Legal Protection Insurers #
Particularly bitter: many of the 400+ unlawfully dismissed cases are now legally final — because legal protection insurers refused to cover appeals:
- Roland: No longer covered appellate proceedings
- LVM: Reduced claim values to insignificance
- DEVK: Covered nothing in the vaccine injury area as a matter of principle
These insurers now face the risk of being sued for damages themselves due to unlawful coverage denials.
Information Asymmetry Broken #
§84a AMG is the legislator’s weapon against the information asymmetry between pharmaceutical corporations and injured individuals. The BGH clarified: when manufacturers only generically contest adverse event reports, internal assessments, or safety data, this constitutes insufficient contestation — with the consequence that plaintiff’s factual assertions are deemed admitted (§138 Para. 3 ZPO).
The Pia Aksoy Case #
- March 2021: Vaccination with AstraZeneca Vaxzevria (conditional approval)
- Afterwards: Tingling in ring finger, numbness in ear
- Diagnosis: Irreversible unilateral hearing loss
- Occupational insurance: Vaccine injury recognized
- Regional Court Mainz: Lawsuit dismissed
- Higher Regional Court Koblenz: Appeal dismissed (Sep 18, 2024, Case 5 U 1139/23)
- BGH: Judgment overturned, remanded (Mar 9, 2026, Case VI ZR 335/24)
The case now returns to the Koblenz court — this time with the BGH’s clear instruction to obtain an expert opinion.
Conclusion #
On March 9, 2026, the Federal Court of Justice did not impose liability. But it destroyed the architecture that had prevented liability until now. The protective shields of the lower courts — erected to the benefit of manufacturers, to the detriment of the injured — are branded as legally erroneous by the highest court.
Whether adequate compensation will actually follow remains to be seen. But one thing is clear: the dismissal routine that has ended every vaccine injury case in Germany is no longer the state of the law since March 9, 2026.
That is, in the legal sense, a turning point.
Sources:
- BGH, Judgment of Mar 9, 2026, Case VI ZR 335/24 (PDF)
- BGH Press Release No. 045/2026
- LTO: BGH Rules on AstraZeneca Disclosure Obligation
- LTO: COVID Vaccine Injuries — BGH Signals Partial Success for Plaintiff
- anwalt.de: Scope of Disclosure Claims Against Vaccine Manufacturers
- Juraarchiv: BGH Ruling Strengthens Disclosure Claims
- Attorney Tobias Ulbrich: Analysis of the Reasoning
- Art. 15 & 17, Regulation (EC) No. 726/2004
- §84, §84a AMG (German Medicines Act)
- §138, §423 ZPO (German Code of Civil Procedure)
