In a legal dispute about harmful side effects of a corona vaccine, the Federal Court of Justice (BGH) has corrected the previous case law on claims for information against pharmaceutical manufacturers: in favor of patients who have allegedly suffered damage to their health from a drug. In the future, the courts will no longer be allowed to set the hurdles for information from pharmaceutical manufacturers as high as they did in the case decided. The statutory right to information about potentially disproportionately risky medications is a tool for injured patients to enforce liability claims, emphasized the presiding judge of the Sixth BGH Senate, Stephan Seiters, in the verdict on Monday.
The highest civil court also made it clear that the right to information against the pharmaceutical companies should be understood “comprehensively”: all effects and findings about the drug must be disclosed, regardless of the individual plaintiff’s clinical picture. According to the will of the legislature, injured parties should be able to obtain “all the facts” so that it can be assessed whether a drug has unacceptable risks, explained Seiters.
Verdict could have a positive impact on claims for damages
After the BGH ruling, it could theoretically become easier for injured parties to enforce claims for damages against pharmaceutical companies. The plaintiff’s lawyer, Volker Loeschner, praised the BGH’s decision on the right to information as “groundbreaking”. With regard to his client’s claim for compensation and pain and suffering, he spoke of a “stage won”. The BGH has decided: If the pharmaceutical company is convicted in further proceedings of providing information about the vaccine, it cannot be ruled out that the plaintiff “can present further facts to justify her claim for damages”.
The 45-year-old dentist Pia Aksoy filed the lawsuit. She is demanding at least 150,000 euros in damages and compensation from the pharmaceutical manufacturer Astra-Zeneca because she went deaf in one ear after her corona vaccination. Aksoy is convinced that this is a corona vaccination damage caused by the pharmaceutical company’s Vaxzevria vaccine. Three doctors and a report confirmed this. So far her lawsuit has been unsuccessful. Now the Koblenz Higher Regional Court must negotiate their claims again. However, it could still be years before it is decided whether Aksoy can demand compensation for damages and pain and suffering from Astra-Zeneca. The comprehensive overall assessment of the vaccination benefits and health risks of the vaccine required by the BGH is a complex task. As the presiding judge Seiters explained, the severity, reversibility, duration and frequency of health risks must be taken into account, among other things.
Deaf in the right ear three days after vaccination
Aksoy was vaccinated against the coronavirus with Vaxzevria on March 5, 2021. Three days later she could no longer hear in her right ear. The medical diagnosis the following day revealed that she was deaf. Healing is no longer expected. What Aksoy didn’t know at the time: After vaccinations with Vaxzevria, rare cases had been reported in which blood clots appeared in unusual places. Two weeks after the plaintiff’s vaccination appointment, Astra-Zeneca added a reference to a risk of thrombosis in the specialist information, which must contain all information about the vaccine that is relevant to the specialist staff. Around three weeks later, the Standing Vaccination Commission changed its recommendation for Vaxzevria: In principle, people aged up to 60 years should no longer be given the vaccine. Unusual cases of thrombosis have been documented, especially after corona vaccinations in people up to this age.
In the trial against Astra-Zeneca, the plaintiffs argued that the vaccine was disproportionately risky and that the information that Astra-Zeneca published about the vaccine at the time did not correspond to the current state of scientific knowledge. The company also violated labeling requirements. Attorney Loeschner was convinced that this will now be proven with the help of expert reports after the BGH ruling was announced. The lower courts had refused to obtain expert opinions. With the approval of the vaccine, it is already clear that the benefits of the vaccine outweigh the health risks. The BGH has now decided that this conclusion was inadmissible.
In the Sixth Senate’s opinion, the OLG’s assumption that the plaintiff’s corona vaccination must be “predominantly likely” to cause the hearing loss in order for her to be entitled to a claim for information against the pharmaceutical manufacturer was also erroneous. The BGH decided that this would impose requirements that were too strict. The fact that there are more arguments against than for the drug as a cause of damage is no reason to withhold information from those who have been injured.
Astra-Zeneca is convinced that Vaxzevria has consistently shown “an acceptable safety profile”. Regulatory authorities around the world have unanimously determined that the benefits of the vaccination outweigh the risks of extremely rare potential side effects, the company said after the verdict was announced. According to Astra-Zeneca, more than three billion doses of the vaccine have been administered around the world. In the first year of use alone, more than six million lives were saved. The number of cases of hearing loss related to the vaccine is less than 2,000. “We are proud of the role that Vaxzevria has played in ending the global pandemic,” emphasizes the company.
