GERMANY —German biotechnology company BioNTech is currently embroiled in a legal dispute as it faces a lawsuit filed by a German woman who alleges that she experienced adverse effects from the company’s COVID-19 vaccine.
This lawsuit is the first of many potential cases in the country, according to Reuters.
The plaintiff, who has exercised her right to privacy and has remained anonymous, is seeking damages of at least €150,000 (US$161,500) for bodily harm and compensation for unspecified material damage.
The case is being heard by the regional court in Hamburg, with the woman represented by law firm Rogert & Ulbrich.
According to the plaintiff, she suffered from upper-body pain, swollen extremities, fatigue, and sleeping disorders as a result of receiving the vaccine. The first hearing for the case took place on Monday, June 12, 2023.
Tobias Ulbrich, a lawyer at Rogert & Ulbrich, expressed his intention to challenge the assessment made by European Union regulators and German vaccine assessment bodies regarding the positive risk-benefit profile of the BioNTech shot.
German pharmaceutical law stipulates that drug or vaccine manufacturers are only liable for damages caused by side effects if medical science demonstrates that their products disproportionately harm individuals compared to the benefits or if there are inaccuracies in the product labeling.
BioNTech, which holds the marketing authorization for the vaccine in Germany (developed in partnership with Pfizer), has deemed the lawsuit to be without merit after careful consideration.
The biotech firm asserted that the vaccine, known as Comirnaty, maintains a positive benefit-risk profile, with a well-characterized safety profile.
BioNTech highlighted that over 1.5 billion people worldwide, including more than 64 million in Germany, have received the vaccine.
The European Medicines Agency (EMA) has also affirmed the safety of BioNTech’s Comirnaty, stating that it is safe for use.
In a recent media briefing, the EMA reiterated the benefit of all approved COVID-19 vaccines, including BioNTech’s, emphasizing that vaccines have been estimated to save nearly 20 million lives globally in the first year of the pandemic.
The EMA has acknowledged a minimal risk of myocarditis and pericarditis, two types of heart inflammation, following vaccination with Comirnaty, primarily in young males.
Unforeseen side effects following regulatory approval of a drug are rare. The expedited development of COVID-19 vaccines during the pandemic may have resulted in certain uncommon side effects not being detected as readily as in traditional longer trials.
The EMA has emphasized that safety monitoring was not compromised during the fast-track assessment process.
As of May, the EMA had received approximately 1.7 million reports of suspected side effects, equating to about 0.2 reports per 100 administered doses.
Within the European Economic Area, comprising EU member states, Iceland, Liechtenstein, and Norway, around 768 million vaccine doses have been administered.
The most commonly reported temporary side effects of the vaccine include headache, fever, fatigue, and muscle pain.
The EMA continues to monitor adverse events and illnesses following vaccination, comparing frequencies with those in the non-vaccinated population.
Regarding liability, it remains uncertain who would bear the legal costs or compensation if the plaintiff succeeds in the case.
Sources indicate that some of the European Union’s bulk purchase agreements with vaccine manufacturers, including BioNTech-Pfizer, may include liability waivers, potentially placing some of the costs on EU governments.
Germany has a no-fault compensation program for individuals who suffer permanent harm from vaccines, but participation in the program does not prevent individuals from seeking separate damages.
In the United States, manufacturers enjoy immunity from liability for COVID-19 vaccines that receive regulatory approval.
Law firms Rogert & Ulbrich and Caesar-Preller have collectively filed around 350 cases on behalf of clients seeking damages for alleged side effects of COVID-19 vaccines in Germany.
A few similar cases have also been filed in Italy.
As the legal battle commences, the outcome of this case will likely set a precedent for the numerous lawsuits that may follow, as individuals seek compensation for alleged side effects of COVID-19 vaccines.
The proceedings will shed light on the legal complexities surrounding vaccine liability and the delicate balance between public health and individual rights.
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