In mid-January 2021, the world was rocked by the news that Norway had registered 29 deaths after the Pfizer/BioNTech coronavirus vaccine was made. Deaths were in people over 75, suggesting that vaccination carries risks for older and critically ill people.
Avoiding risks: how vaccination works
As a member of the Ukrainian Bar Association, medical lawyer Zinaida Chuprina said in a comment to , if we talk about the vaccination process in general, and not just about vaccination against COVID-19, we need to understand that this is a complicated procedure.
Vaccination is essentially a medical intervention. Before it is carried out, the doctor must provide the patient with a document for signing—voluntary informed consent. Before the patient signs the consent, the doctor is obliged to tell what infection is being vaccinated against, what is the name of the vaccine that will be used, about the presence and possible adverse reactions. The doctor must also answer all the patient's questions about vaccination. Zinaida Chuprina emphasizes that the vaccination procedure is absolutely voluntary and, if there is any doubt, the patient has every right to refuse to be vaccinated.
"Before being vaccinated, the patient must go to the family doctor and undergo an examination. This is necessary because preventive vaccination can be given to a conditionally healthy person. The doctor is obliged to measure the temperature, pulse, pressure, respiratory rate, and make sure that there are no health complaints. In addition, the doctor must find out if the patient has chronic diseases, allergies to drugs, find out what was the body's reaction to previous vaccinations," she said.
This data, as well as the signed voluntary informed consent, must be reflected in the patient's medical record.
Member of the Ukrainian Bar Association, lawyer Rostislav Litvinov recalled that the European Medicines Agency (EMA) on December 21, 2020, certified a coronavirus vaccine produced by BioNTech and Pfizer. This means that these companies’ vaccine can be used not only in the United States and Great Britain, but also in the countries of the European Union.
"US law provides legal immunity to companies that produce coronavirus vaccines. And that means that such companies are exempt from any liability if patients develop any adverse reactions to vaccines," he added.
Zinaida Chuprina advises not to leave the hospital within the first 30 minutes after vaccination. This is a precautionary measure in the event of an unexpected reaction to the vaccine. In this case, the patient can receive immediate medical care.
If side effects do happen, it is needed to look at what exactly happened and what caused them.
"If these complications were described by the manufacturer in the annotation to the vaccine and the patient was informed about them by the doctor, then, most likely, no one will be held responsible, or the responsibility can be equally imposed upon both the doctor and the patient. Here it is needed to deal with each case individually. If it is determined that the doctor allowed the patient to be vaccinated provided that there were direct contraindications, then this is the doctor's direct fault. If complications appear that have not been described by the manufacturer and a direct causal relationship is established between the vaccination and the negative health effects that have occurred, then it will be the manufacturer's fault. If the vaccine turned out to be of poor quality because of the improper storage or transportation, then it will be necessary to determine who is to blame," she said.
But if, because of the vaccine, the patient has serious health consequences, then they have the right to contact the police and initiate a criminal case. As part of the criminal case, appropriate expertises will be carried out and the investigation will have to identify the persons who are guilty of the consequences that have occurred.
How the vaccines registration is carried out in Ukraine
According to Rostislav Litvinov, in order to use vaccines in Ukraine, an individual or legal entity that is responsible for the quality, safety, and efficacy of a medicinal product (applicant) must submit an application for state registration of a vaccine to the Ministry of Health (Clause 3 of the Resolution of the Cabinet of Ministers of Ukraine dated May 26, 2005 No.376 "On Approval of the Procedure for State Registration (Re-registration) of Medicines and the Amount of Fee for Their State Registration (Re-registration), Procedure No.376".
The fact of a medicinal product’s state registration is certified by a registration certificate for a medicinal product, the fact of a medical immunobiological product’s state registration is confirmed by a registration certificate for a medicinal product (medical immunobiological products).
During the validity period of the registration certificate, the applicant is responsible for the effectiveness, safety, and quality of the registered medicinal product, takes measures to improve the production scientific and technical level and guarantee the quality of the registered medicinal product that are established in Ukraine (clause 7 of Order No.376).
According to the current legislation of Ukraine, individual or legal entity applying to the Ministry of Health for medicinal product registration, hereinafter referred to as the applicant, (and during the entire period of the medicinal product registration certificate validity), and in our case, the coronavirus vaccine is also a medicinal product according to Art. 2 of the Law of Ukraine "On Medicines"), is responsible for the effectiveness and safety of this medicinal product.
In the case of negative consequences from such a vaccine, the applicant is responsible.
Is it possible to sue for side effects?
According to Rostislav Litvinov, similar norms are reflected in the Law of Ukraine "On liability for harm caused as a result of a defect in products." They establish that the product is defective if it does not correspond to the level of safety that the consumer or user has the right to rely on based on all circumstances, in particular those related to development, production, circulation, transportation, storage, installation, maintenance, consumption, use, elimination (disposal, recycling) of these products, as well as the provision of reservations and other information about such products (Article 5 of the Law of Ukraine).
Article 7 of the Law of Ukraine "On liability for harm caused as a result of a defect in the product" provides that the manufacturer is responsible for the harm caused as a result of a defect in the product.
Any person who imported products into the customs territory of Ukraine for the purpose of selling, renting, leasing or distributing in any other form in the course of economic activity, in accordance with this Law, is responsible as a manufacturer.
"In our case, vaccine manufacturers have legal immunity, besides, the coronavirus vaccine will be imported into the territory of Ukraine by an individual or legal entity who will apply to the Ministry of Health for medicinal product registration, therefore, the applicant will be liable as a manufacturer," he said.
Person affected by vaccination or their relatives can go to court with a claim for moral and material harm compensation to individual or legal entity who applied to the Ministry of Health for medicinal product registration.
Before going to court, it will be necessary to collect a package of documents (certificates, medical reports, expertises results that would confirm the harm to life and health, a vaccine defect, and a causal relationship between vaccination against coronavirus and the negative consequences of it (side effects in the form of severe harm to health, death).
In turn, you can also go to court with a claim to the Ministry of Health to prohibit the use of a coronavirus vaccine in the case of previously unknown dangerous vaccine properties.
Practical example: how to sue with a vaccine manufacturer
Rostislav Litvinov cited the US Supreme Court as an example. In 2011, it made a decision providing strong protection to vaccine manufacturers from lawsuits filed by parents whose children had been affected by vaccines.
"The Supreme Court ruled that such claims against medicinal product manufacturers were effectively blocked by Congress in 1986, when a special judicial body was created to deal with such complaints. At that time the court ruled in favor of Wyeth currently owned by the world's largest pharmaceutical company Phizer," he said.
The court rejected the claim of the American married couple Russell and Robalie Brusewitz who demanded compensation for material damage. The couple said that after their daughter received routine vaccinations at the age of six months, she developed seizures that led to serious cerebral impairment. She is now 19 years old, but she still has the vocabulary of a young child.
Plaintiffs insisted that this all happened to their daughter because of this diphtheria, pertussis, and tetanus vaccine, but Wyeth denied this. The vaccine was withdrawn from the market in 1998.