A 33-year-old woman’s health was severely impaired after her Covid vector vaccination in March 2021: Shortly after the shot, she suffered an intestinal vein thrombosis and had to have more than three meters of her intestines removed. The consequences will accompany you throughout your life. She went to court and sued the manufacturer for damages and damages. But the lawsuit was dismissed because the risk-benefit ratio of the vaccination was impeccable, the court found.
The plaintiff’s story of suffering is affecting. She received her Covid vaccination on March 10, 2021 and had to be on sick leave for the following two days due to fever, headache and body aches. On March 20, malaise, diarrhea and pain in the lower abdomen set in, the 33-year-old, like her family doctor, initially assumed a gastrointestinal infection. On March 25, the plaintiff noticed blood in her stool and called an ambulance. From that day until May 3, she was hospitalized.
Three meters of intestine removed – lifelong impairments
Intestinal vein thrombosis was diagnosed. “Whether the intestinal vein thrombosis occurred in combination with thrombocytopenia syndrome (TTS) is disputed between the parties,” the court said. The further process is described as follows:
On March 25, 2019, more than 3 m of the intestine was removed from the plaintiff in the course of a small intestine resection due to a thrombectomy. The plaintiff was in the period from 25.03. until 03/29/2021 in a coma and was ventilated invasively, until 04/07/2021 the plaintiff was in the intensive care unit. On April 7th, 2021, the plaintiff was transferred to the normal ward. The plaintiff suffers permanent damage as a result of the small bowel resection. She remains disabled to this day and may not be able to return to her job. The plaintiff is extremely restricted in her diet, she has to follow a strict diet and observe numerous dietary requirements. It may not be possible for the plaintiff to become pregnant. The plaintiff suffers from pain, massive diarrhea with high loss of fluids, fatty stools, weight loss, loss of electrolysis, deficiency symptoms, lactose intolerance and osteoporosis. She needs to go to the bathroom more than 16 times a day. There are also insomnia, fatigue, concentration problems and depression.
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“Positive risk-benefit ratio”
Thrombosis is a side effect of the AstraZeneca/Vaxzevria vaccine that is well known today. At the time the plaintiff was vaccinated, however, only eleven reports of thromboembolic events after the injection were reported in Germany. Despite the later recognition of this side effect by manufacturers and authorities, the allegedly positive risk-benefit ratio of the vaccination was always emphasized – and the court is now insisting on this:
According to S. 84 Para. 1 S. 2 No. 1, the pharmaceutical entrepreneur is liable if the medicinal product has harmful effects that go beyond what is justifiable according to the findings of medical science. In other words, liability only exists for medicines that have a negative benefit-risk ratio. […] There is no indication of a negative benefit-risk profile. In this context, it is not decisive whether there was a negative benefit-risk profile for the plaintiff personally, since it depends on all potential users.
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“Undisputed” effect of vaccination
The court explained that the EMA, among others, had repeatedly found a positive benefit-risk ratio. The specific case of the plaintiff, on the other hand, seems irrelevant:
The plaintiff counters the fact that a positive benefit-risk profile was repeatedly established, stating that for the plaintiff an almost complete bowel loss is a disproportionate consequence of the vaccination and that intestinal vein thrombosis and TTS can lead to death. Irrespective of the fact that – as already explained – the focus should be on all potential users, it should also be noted that the risk that can be classified as acceptable depends on the indication of the medicinal product and its therapeutic effectiveness. The better the therapeutic efficacy of the drug and the more serious the indication, the more severe adverse effects can be tolerated. If the drug z. B. used to treat a disease with a high mortality rate, particularly serious and potentially fatal side effects may also have to be accepted as long as their probability of occurrence is rather low (cf. Kügel/Müller/Hofmann, loc.cit., marginal number 83). A double vaccination with V. undisputedly protects against Covid-related hospitalization and death with an effectiveness of over 90%. In contrast, the EMA and the PRAC have repeatedly stated that a TTS can (only) occur in very rare cases.
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The fact that a 33-year-old from Covid-19 never posed any significant danger is ignored. The court continued to find no information error and no decision conflict: the product information at the time of vaccination would have corresponded to the state of the art and it is assumed that the (exaggerated) risk of serious Covid consequences would still increase even if all side effects of the vaccination had been explained vaccination decision could have led.
Therefore, taking into account the applicant’s reasoning that she probably would not have been vaccinated because she was very cautious, the Chamber cannot form the corresponding conviction that there was a decision conflict, since a cautious patient who, like the plaintiff is in training and has professional contact with numerous different people, it is obvious that in the case of a highly contagious disease such as COVID-19, the lower thrombosis risk of a vaccination would be chosen instead of the higher thrombosis risk in the event of an infection, without her being in get into a decision conflict.
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The young woman’s claim is therefore dismissed. She is left with the costs of the lawsuit.