Case T-265/25: Action brought on 17 April 2025 – IW v Commission and EMA
Date: 2025-04-17
Institutions: General Court
Subjects: contract, coronavirus disease, drug surveillance, epidemic, health risk, liability, market approval, transparency in decision-making, vaccine








C_202503308EN.000101.fmx.xml












Official Journal of the European Union


EN
C series













C/2025/3308


24.6.2025






Action brought on 17 April 2025 – IW v Commission and EMA


(Case T-265/25)

(C/2025/3308)
Language of the case: Italian

Parties


Applicant: IW (represented by: G. Passalacqua, lawyer)

Defendants: European Commission, European Medicines Agency

Form of order sought

The applicant claims that the General Court should:






—


find that the European Commission and the European Medicines Agency (EMA) have incurred non-contractual liability for the damage caused to the applicant within the meaning of paragraph 2 of Article 340 TFEU, arising from the unlawful acts and conduct of the defendants in connection with the approval, purchase and deployment of the vaccine against Covid-19, known as the ‘Covid-19 Vaccine AstraZeneca’, and consequently order the defendants to pay compensation.





Pleas in law and main arguments

In support of the action, the applicant relies on three pleas in law.






1.


First plea in law, alleging that the vaccine authorisation/marketing procedure was unlawful.
The Commission and EMA authorised the marketing of the AstraZeneca vaccine in the healthcare system without prior scientific assessment of the composition and side effects. In particular, the applicant alleges that there was a failure to evaluate and report the thrombolytic risks for vulnerable individuals. The lack of such information in the information leaflet undermined the adequacy of the information. Proper knowledge of the risk profile would have prevented potentially harmful administration of the vaccine.










2.


Second plea in law, alleging infringement of the transparency obligations.
The Commission infringed transparency requirements when it concluded the contracts for the supply of vaccines, as found by the General Court of the European Union (T-689/21, Auken and Others v Commission and T-761/21, Courtois and Others v Commission), even refusing the European Parliament access to information.
The applicant criticises the presence of (or failure to exclude) waiver of liability clauses for the benefit of producers, which prevented full disclosure of the risks and precluded the Commission’s resulting liability for placing a defective product on the market.
The AstraZeneca vaccine was administered to certain individuals subject to mandatory vaccination – such as teaching staff – without information as to the serious thrombolytic risks, later recognised by EMA.
The update to the information leaflet came late, after serious events had already occurred, including the one related to lot ABV5811.
The Commission disregarded the duty of vigilance concerning evolving scientific knowledge and the duty to provide adequate information.
That conduct amounted to liability for damages resulting from dangerous activity within the meaning of Article 2050 of the Civil Code, aggravated by the failure to adopt precautionary measures.










3.


Third plea in law, alleging proof of a causal link.
In the context of criminal proceedings before the Public Prosecutor’s Office, Latina, Italy, two technical specialist consultants (in infectious diseases and forensic medicine) established the plausibility of the causal link between the administration of the AstraZeneca vaccine (Vaxzevria) and the thrombolytic event suffered by the applicant. The forensic doctor’s expert report, submitted on 10 January 2022, attributed the ischaemic stroke of 14 March 2021 to an adverse reaction to the vaccine. The CMO reached similar conclusions at the medical assessment, which recognised the debilitating effects of the event and the related link with the vaccine. Those technical-scientific findings amount to material evidence of liability resulting from the drug authorisation and distribution chain, aggravated by the failure to anticipate and communicate the risks.






ELI: http://data.europa.eu/eli/C/2025/3308/oj
ISSN 1977-091X (electronic edition)