Partial victory at the Federal Court: AstraZeneca must provide information.

As a dentist, it was important for her to be able to treat her patients again through direct contact. "Then I was vaccinated and I immediately felt the side effects at the vaccination center. Tingling in my little and ring fingers, numbness in my arm. Afterwards, I experienced side effects such as fever and pain." Pia Aksoy says she accepted these side effects. But three days later, the dentist suddenly suffered hearing loss and permanent deafness. She is certain that the Vaxzevria vaccine was the cause. Nothing else is possible. Pia Aksoy holds the vaccine manufacturer AstraZeneca responsible for her hearing damage. She has filed a lawsuit and is demanding comprehensive information about the known risks of the coronavirus vaccine. She is also demanding 150,000 euros in damages and further compensation. She took her case through the courts all the way to the Federal Court of Justice (BGH) and has now achieved a partial victory. The BGH ruled that plaintiffs need information from pharmaceutical companies about known vaccine risks. Otherwise, potential vaccine victims would never have a chance to get lucky in a lawsuit. The obstacles to asserting the right to information should not be too high. This was also the legislator's intention. Stephan Seiters, president of the Sixth Civil Senate, emphasized during the judgment: The injured party must show more than just a suspicion that the vaccine was the cause of the health damage. However, it is sufficient if there are "indications" of a causal connection. The requirements should not be too strict. Even if the evidence against a vaccine causing health problems outweighs the evidence for it, the manufacturer must be able to provide information. It is sufficient that the health problems resulting from the vaccination are plausible. The Federal Court of Justice (BGH) has now referred the case back to the lower courts. Pia Aksoy is convinced: "We have come this far, and now we will continue on this path with full strength and confidence, so that justice will ultimately prevail." Today’s decision does not automatically mean that Pia Aksoy will win. In any case, the Federal Court’s decision has general implications for what information vaccine manufacturers must disclose. The Federal Court rules that if there is a right to information, pharmaceutical companies must also provide comprehensive information about the risks of a vaccine – and not just information about a plaintiff’s individual case of illness. Benefits and risks must be weighed. Whether AstraZeneca ultimately has to pay damages and compensation depends on a balancing of interests – between the benefits and risks of an AstraZeneca vaccination during the COVID-19 pandemic. Were the vaccine risks acceptable at the time, given the dangers of the pandemic? In other words, was the benefit-risk assessment justified in favor of AstraZeneca? This is the essential question that a court must answer in Pia Aksoy’s case in order for any monetary claims to be made. In its ruling, the Federal Court (BGH) stated that the lower courts had also made legal errors in this case. The requirements for what the applicant had to provide in connection with the risk-benefit assessment were also considered to be too strict.