Earlier this year, Andreas Eustacchio at BOKS member firm, EUSTACCHIO Rechtsanwälte, provided a guest commentary in the Austrian newspaper, Die Presse, on how the liability for COVID-19 vaccine damage has been delegated to the EU.

In the article, translated into English below, Andreas considers how liability would ultimately have to be borne by the EU member states in the event of a causal connection between the vaccination and complications. Yet, he argues why it would not have been necessary to assume liability from a legal point of view. According to the product liability rules, at least for the EU-member states, but also other countries (e.g. for the UK see the Consumer Protection Act), manufacturers are not liable if they can prove that they have developed and produced their products in accordance with the state of scientific and technical knowledge. The article triggered a discussion in Austria, but also in Germany, about the necessity of assuming liability. wallstreetonline.de also reported: Haftungsfrage bei Astrazeneca – Anwalt sieht EU-Länder in der Pflicht – 19.03.2021 (wallstreet-online.de)

Vienna. When the EU Commission was criticized at the beginning of the year because it had not made any commitments with the pharmaceutical company AstraZeneca for the delivery of certain quantities of its corona vaccine, but only an “effort”, it made the contract public to prove the opposite. In addition, under blackened passages, parts of an EU promise to reimburse the Group for compensation payments to victims of vaccinations, including any legal costs in the future, came to light. 

Something similar can be found in the – also partially published – contracts with competitors Curevac and Sanofi. Thus, the EU and its member states are contractually cushioning at least some manufacturers from the entrepreneurial risk of possible vaccine damage and related compensation. Why?

So far, based on studies by the European Medicines Agency (EMA), the EU Commission has approved the corona vaccines from AstraZeneca and other manufacturers for the EU. In the meantime, one hears about vaccine reactions, side effects, physical intolerances and other symptoms about various vaccines. Occasionally people have died after vaccinations. So while other countries are suspending the AstraZeneca vaccination, Austria is sticking to it because the advantages outweigh possible risks.

First of all, we are interested in whether the EMA checks carefully enough, despite time pressure and political pressure. In the approval process, a vaccine is examined to determine whether its benefits outweigh the risk of damage to health. Neither 100 per cent safety nor absolute effectiveness is required, let alone producers claim this. The manufacturer bears the liability risk despite approval.

According to the Vaccination Damage Act (Austria), the Republic of Austria pays compensation for treatment and rehabilitation costs in the event of an obligation or recommendation to vaccinate and a one-off compensation in the event of serious bodily harm; there is a vaccination recommendation for corona vaccines in Austria. However, claims for other vaccinations have been denied in most cases in recent years.

The Product Liability Act (PLA for Austria), as an implementation of the EC Product Liability Directive 85/374, directed against manufacturers and independent of fault, could offer injured parties more opportunities. However, product liability suits also sometimes fail because the injured party cannot prove that a specific product caused the damage. A mere temporal connection between vaccination and damage is usually insufficient to prove that the product is defective. But why is the EU stepping into the breach by assuming liability for AstraZeneca

ECJ (European Court of Justice) supports injured parties supports injured parties

The reason could be a spectacular ECJ decision from 2017 (C-621/15 ), which significantly lowered the hurdle for the burden of proof in favour of vaccine victims under the EU Product Liability Directive: A patient with no previous illness was vaccinated against hepatitis B vaccination. He contracted multiple sclerosis shortly afterwards. Although there was no scientific evidence of MS as a sequelae of hepatitis vaccination, According to the ECJ, “clear and consistent” circumstantial evidence is also sufficient to establish a causal link between the vaccination and the disease. Such indications are the absence of previous illnesses and a significant number of similar cases.

It is possible that, in view of this reduced standard of proof in the sense of “prima facie” evidence in favour of injured parties, AstraZeneca was particularly concerned to wring an assumption of liability from the EU. However, according to the ECJ, the injured party is not entitled to compensation if the manufacturer proves that the vaccine is not the cause of the alleged disease (reversal of the burden of proof).

What is the state of scientific and technical knowledge?

And the PLA also provides for a special feature. Even if the injured party succeeds in proving that the product is the cause of the vaccine damage and thus has a defect, the manufacturer is exempt from liability if he can prove that he developed and produced the vaccine according to the state of scientific and technical knowledge. It is conceivable that years after approval, scientific methods that today are not yet known may show a causal connection with vaccine damage. In this regard, manufacturers would consequently be protected from liability under the PLA. If manufacturers were to take the incalculable risk of developing a vaccine – despite adhering to all the latest scientifically known and available methods today – this would nip the willingness of many research companies to innovate in the bud. Such a balance of interests is understandable, especially when fighting a global pandemic. Especially against the background of this exclusion of liability, which benefits manufacturers in Europe according to the EC-Product Liability Directive, an assumption of liability by the EU for Covid 19 vaccine companies must be questioned. In any case, it could be interesting to see what the current state of scientific and technical knowledge in the development of a corona vaccine represents.

In any case, the contractual liability regulation does not change the fact that AstraZeneca would first have to defend itself against claims for damages in a lawsuit. Only in the event of a final conviction or a settlement made with a person suffering from a vaccination with the consent of the EU Commission would a payment by the EU member states become effective.

Dr. Andreas Eustacchio, LL.M., is a partner at Eustacchio Lawyers in Vienna.

You can read the original article in German here.

If you would like to discuss this article with Andreas, or indeed make contact with EUSTACCHIO Rechtsanwälte for anything else, please do so at [email protected] or by calling 0043 1 319 97 00.