Germany launches lawsuit over side effects of BioNTech vaccine

On Monday, BioNTech will be subpoenaed to respond to a woman’s allegations that she experienced serious side effects from the Covid-19 mRNA vaccine. This is the first of hundreds of lawsuits she has faced in Germany.

The plaintiff, whose details are not disclosed under privacy laws, claims that the German company’s vaccine caused her pain in her torso, swelling of her limbs, fatigue and sleep disturbances. Her lawyer, Tobias Ulbrich of Rogert & Ulbrich, told Reuters that he would dispute European and German regulators’ assessment that BioNTech’s vaccine has a positive risk-benefit profile.

The woman is seeking damages of at least EUR 150,000 for alleged damage to her health and an unspecified amount of compensation for material damage. According to German law, manufacturers of medicines or vaccines are only required to pay compensation for side effects if “medical science” shows that their products cause harm that is not commensurate with the benefits, or if the information in the product brochure is incorrect.

However, it is difficult to dispute the assessment of the positive profile of vaccines, given that last week the European Medicines Agency confirmed the safety of vaccines and indicated that in the first year of the pandemic alone, vaccines saved nearly 20 million lives worldwide. However, the EMA has recognized that the risk of myocarditis and pericarditis from the Pfizer/BioNTch vaccine is very low, especially for young men.

BioNTech response

For its part, BioNTech stated that it carefully examined the plaintiff’s allegations and considered them unfounded. “The positive benefit-risk profile of the vaccine remains positive and the safety profile has been adequately characterized,” the company said, noting that the vaccine has been administered to approximately 1.5 billion people worldwide, including 64 million in Germany.

By May, the EMA had received almost 1.7 million reports of possible side effects, which equates to about 0.2 reports per 100 doses of the vaccine. However, many of these reports are likely to refer to symptoms occurring incidentally after vaccination, which is statistically expected given the large number of vaccinations. To assess whether symptoms are indeed vaccine-related, the EMA looks at how common they are in the vaccinated population compared to the unvaccinated population.

Who will pay compensation?

It is not yet clear who will pay compensation and pay legal costs if BioNtech is found guilty, Reuters comments. Contracts concluded EUbasically exempt pharmaceutical companies from legal liability, which means that Member States will bear part of the costs.

Germany and many other countries have also set up special funds to compensate citizens who have suffered irreversible damage from vaccines, but compensation from the fund does not rule out the possibility of a separate litigation.

The situation is clearer in the US, where pharmaceutical companies are completely exempt from liability.

In Germany, the majority of plaintiffs are represented by two law firms: Rogert & Ulbrich, which said it has about 250 clients claiming damages, and Caesar-Preller, which represents another 100 cases.

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