Spain: Causation-Related Factual Evidence: ECJ Judgment Interpreted By Spanish National Court

Last Updated: 16 January 2020
Article by Carolina Revenga and Jorge Etreros Arnanz


Until recently, the Spanish courts had neither applied nor referenced the 21 June 2017 ruling by the European Court of Justice (ECJ) on the Hepatitis B vaccine. However, that changed in June and July 2019 when the Spanish National Court handed down judgments in two separate cases (for alleged damages following administration of an HPV vaccine), both of which referred to and interpreted the ECJ ruling. This article provides an overview of the conclusions reached by the National Court, as well as the potential implications of its interpretations of the 2017 ECJ judgment.

The 2017 ECJ judgment summarised

By way of background, the European Court of Justice concluded in 2017 that when medical evidence neither establishes nor rules out the existence of a link between a vaccine's administration and the occurrence of a disease, the existence of a causal link between the defect attributed to the vaccine and the damage suffered by the victim could be considered to be established on presentation of certain predetermined causation-related factual evidence, that is when "solid, concrete and concordant evidence" concurs.

In the 2017 case, an expert report had concluded that the weight of the scientific literature did not clearly establish a direct relationship between the vaccine and the disease. However, such a relationship could not be ruled out, given the temporal coincidence between the administration of the vaccine and the onset of the disease. A scientific study supporting the association between the disease and the vaccine was also produced as evidence, along with a decision from the French administration.

Background to the recent Spanish cases

Separate contentious-administrative actions were brought by two girls against the Spanish Ministry of Health and a manufacturer of HPV vaccines. Each plaintiff sought economic compensation for alleged suffering following administration of the vaccine. Both alleged adverse neurological adverse reactions that had not been mentioned in the patient information leaflet nor in the summary of product characteristics of the vaccine.

The plaintiffs also alleged (i) the liability of the Spanish Ministry of Health for financing the vaccine and including it in the Spanish vaccination calendar, (ii) a lack of safety studies into the vaccine, (iii) the vaccine's ineffectiveness and (iv) lack of compliance by the laboratory with its pharmacovigilance obligations.

The plaintiffs' medical records did not evidence a causal relationship between the alleged diseases and the administration of the vaccine but did indicate that the onset of the alleged diseases happened after the administration of the vaccine. There was therefore an apparent temporal coincidence between the administration of the vaccine and the onset of the alleged diseases.

A large number of clinical trials, studies and papers by worldwide health authorities evidencing the safety and positive risk-benefit profile of the vaccine were filed in support of the lack of causal relationship.

An expert report issued by a neurologist evidenced (i) errors in the medical diagnoses and (ii) the absence of causal relationship on the basis that none of the following three criteria were met: temporal, biological and epidemiological. In relation to the temporal criteria, the expert concluded that the onset of the diseases was either too early or too late to be linked with the administration of the vaccine.

The Spanish judgments in focus

Once it had reviewed the evidence, the National Court issued two 2019 judgments dismissing the actions brought by the plaintiffs on the basis that (i) some of the diseases were incorrectly diagnosed, (ii) the weight of the scientific evidence supported the vaccine's safety and positive risk-benefit profile of the vaccine and (iii) the expert report clearly ruled out a causal relationship between the alleged diseases and the administration of the vaccine.

In relation to the ECJ's June 2017 ruling, the National Court concluded the following (in both its 2019 judgments) "Finally, the ECJ dated 21 June 2017 (Case C-621/15), provided by the plaintiff, does not obstruct the conclusion reached, since in this case the facts alleged in the lawsuit do not constitute "solid, concrete and concordant evidence" that would allow us to conclude that the vaccine suffers from a defect and that there is a causal relationship between the defect and the disease."

So although temporal coincidence and the lack of any previous history of related diseases were argued, the National Court reasonably decided not to apply the ECJ judgment. This was because the evidence was not solid enough to conclude both that the vaccine was defective and that there was a causal relationship between the vaccine's administration and the disease.


The recent judgments issued by the Spanish National Court, interpreting the ECJ's 2017 ruling offer helpful guidance in two areas, providing (i) criteria on what can be considered as solid evidence of defect and causal relationship and (ii) the premise used to justify the absence of a causal link between the administration of the vaccine and the onset of the diseases.

Where criteria on what constitutes solid evidence of defect or causal relationship is concerned, the only evidence produced in the two cases before the National Court was (a) an apparent temporal coincidence between the administration of the vaccine and the onset of disease and (b) the absence of any history of related disease in the plaintiffs prior to the administration of the vaccine in question.

Although both facts could have been considered as solid evidence, in light of the ECJ's ruling, the National Court did not consider them to be solid enough to find the presence of either a causal relationship or a defect. This could be viewed as a positive outcome of the interpretation of the ECJ Judgment for manufacturers given that both judgments set a reasonable standard when interpreting facts and evidence.

On the other key issue – the premise used to justify the absence of any causal link – the Spanish National Court based its interpretation on a lack of solid evidence rather than on the premise that medical evidence ruled out the existence of a link between the administration of the vaccine and the occurrence of disease. This had also been the premise on which the ECJ's 2017 ruling was based:

"(...) notwithstanding the finding that medical research neither establishes nor rules out the existence of a link between the administering of the vaccine and the occurrence of the victim's disease".

This raises two questions (i) what would the National Court have concluded if the evidence had been more solid and (ii) would solid evidence have been enough to discredit the weight of scientific evidence?

In our opinion, even if there had been more solid evidence, the National Court would have reached the same decision on the basis of the weight of the scientific literature and the expert report. This view is based on the fact that, prior to analysing the 2017 ECJ judgment, the National Court clearly ruled out the causal relationship based on the scientific evidence filed on behalf of the manufacturer.

For the moment, this first interpretation of the ECJ's judgment is positive and suggests that a similar line of reasoning would be followed by the courts in future.

Click here to read the full publication

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

To print this article, all you need is to be registered on

Click to Login as an existing user or Register so you can print this article.

In association with
Related Topics
Related Articles
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of

To Use you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.


The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.


Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions