In a landmark development, BioNTech SE, the German biotechnology company that partnered with Pfizer Inc. to produce one of the first COVID-19 vaccines, is now facing its first legal challenge in Germany over vaccine side effects.
In an unprecedented case that could potentially spark hundreds of similar claims across Germany, the plaintiff – a woman who has chosen to remain anonymous due to Germany’s privacy laws – is suing BioNTech for a minimum of €150,000 ($161,500) in damages.
According to Reuters, she cites “damages for bodily harm as well as compensation for unspecified material damage,” as detailed by Hamburg’s regional court and the law firm representing her, Rogert & Ulbrich.
Side effects listed in the suit include upper-body pain, swollen extremities, fatigue, and sleeping disorders attributed to the BioNTech Pfizer vaccine.
The landmark case’s first hearing will take place on Monday.
More lawsuits are coming in Germany. Rogert & Ulbrich reports filing about 250 cases for clients seeking damages for COVID-19 vaccine side effects. Another law firm, Caesar-Preller, claims to represent 100 cases, collectively covering almost all such cases in Germany. A few similar cases have been filed in Italy.
Tobias Ulbrich, a lawyer at Rogert & Ulbrich, told Reuters he aimed to challenge in court the assessment made by European Union regulators and German vaccine assessment bodies that the BioNTech shot has a positive risk-benefit profile.
German pharmaceutical law states that makers of drugs or vaccines are only liable to pay damages for side-effects if “medical science” shows that their products cause disproportionate harm relative to their benefits or if the label information is wrong.
BioNTech, which holds the marketing authorisation in Germany for the shot it developed with Pfizer , said it concluded after careful consideration that the case was without merit.
“The positive benefit-risk profile of Comirnaty remains positive and the safety profile has been well characterised,” the biotech firm said, referring to the vaccine’s brand name.
It noted about 1.5 billion people had received the shot across the world, including more than 64 million in Germany.
The European Medicines Agency (EMA) also claimed that BioNTech’s Comirnaty, the most prevalent vaccine in the Western world, is “safe for use.”
EMA claimed that vaccines have helped save almost ’20 million lives globally’ in the first year of the pandemic alone. While acknowledging a ‘rare’ risk of myocarditis and pericarditis, two types of heart inflammation, primarily in young males post-vaccination, the EMA affirms that safety monitoring was not compromised during fast-track assessments.
Reuters reported that the liability issue remains uncertain, especially regarding who would pay legal costs or compensation if the plaintiff wins. EU’s bulk purchase agreements with vaccine manufacturers, including BioNTech-Pfizer, reportedly contain full or partial liability waivers for legal costs and potential compensation, which could force EU governments to bear some costs.
Germany, like many countries, has a no-fault compensation program for individuals who suffer permanent harm from vaccines. However, participation in this program does not preclude an individual from seeking damages separately.
In contrast, the United States has granted manufacturers immunity from liability for COVID vaccines receiving regulatory approval.