Previously, in the article “Legislative requirements for preventive vaccinations (vaccinations),” we examined the basics of legal regulation of preventive vaccinations (vaccinations). It should be noted that vaccination belongs to the category of medical interventions and, like any medical intervention, allows for voluntary informed refusal. At the same time, in case of refusal to vaccinate, we have an obvious conflict between the rights of one person and public benefit (since refusal to vaccinate reduces herd immunity and increases the likelihood of epidemics). This forces us to pay special attention to the legal aspects of obtaining consent (or refusal) from preventive vaccinations (vaccination) and the legal consequences of refusing vaccination.
The rapid development of immunoprophylaxis over the past two decades, associated with the creation of new combined vaccines and advances in immunology, has made it possible to understand many aspects of the vaccine process and change traditional approaches to vaccine prevention: to narrow the list of exemptions from vaccinations, highlighting as a priority the immunization of sick, weakened, and or other chronic pathology.
Despite evidence of the high effectiveness of vaccination, the necessity and procedure for its implementation are causing fierce debate around the world. In this regard, in recent years, against the backdrop of significant successes in the fight against a number of infectious diseases in developed countries, supporters of the anti-vaccination movement have become more active.
In their activities, they operate with a set of cleverly packaged false information that discredits vaccination in general and individual vaccines in particular. It is precisely due to its mythical nature that anti-vaccination disinformation circulates in the minds of the population despite and at the same time with the facts refuting it.
However, the value of vaccination cannot be questioned simply because the media, the Internet, and anti-vaxxer groups continually feed and amplify parental fears and refusals with sensationalized and biased information about complications ranging from autism to diabetes, without any proper scientific evidence of the relationship. No child should die from a preventable cause, and all children should have the opportunity to achieve their full potential for health and well-being. The return of dangerous infectious diseases at the present time suggests that it is very important for people to educate themselves in the field of immunization problems and its legal regulation, weighing all the benefits and risks only through obtaining objective information based on scientifically proven, substantiated and official facts and documents.
Of course, vaccination is not without its drawbacks and requires improvement, since, like any other medical intervention, it is associated with the risk of complications. But their percentage is so small that it pales in comparison to the high effectiveness and significant success of preventive vaccinations in reducing morbidity and mortality from infectious diseases.
It should be noted that the practice of vaccination, akin to any mass event, is inevitably associated with certain organizational, methodological and legal difficulties. This, in turn, leads to unfounded claims being made against medical organizations by supporters of the anti-vaccination movement and, as a result, to inspections by supervisory authorities and litigation.
Judicial practice related to post-vaccination complications
The driving force behind the anti-vaccination movement is post-vaccination reactions and complications. It is the psychology of their perception, or rather, its anomalies among traffic participants, that become the subject of litigation and litigation. Conventionally, all judicial practice in such cases can be divided into two groups:
- Real cases of post-vaccination reactions and complications (decision of the Industrial District Court of Stavropol dated November 17, 2010 in case No. 2-3050/2010; Resolution of the Volgograd Regional Court No. 44G-98/2019 4G-1286/2019 dated March 29, 2021 on case No. 2-16/2018; decision of the Megion City Court of the Khanty-Mansiysk Autonomous Okrug - Ugra dated June 27, 2021 in case No. 2-453/2018), caused by violations by employees of medical organizations of the requirements for preventive vaccinations against infectious diseases. In 2018, the court recovered 1,200,000 rubles from doctors in favor of the parents of a 3-month-old boy, who was vaccinated (against polio and DPT) in violation of the requirements and contrary to a medical exemption (the boy had a primary immunodeficiency state - clause 2 of the List medical contraindications to preventive vaccinations, approved by the Chief State Sanitary Doctor of the Russian Federation, First Deputy Minister of Health of the Russian Federation on January 09, 2002).
According to the child’s mother, approximately 4 days after vaccination, her son developed loose stools, a fever, and completely immobilized his limbs. The boy was hospitalized with a diagnosis of “acute viral myelitis, flaccid tetraparesis with moderate motor impairments in the arms, severe motor impairments in the legs.” The child was in hospital for four months, including preventive treatment, after which the final diagnosis was established: “a polyviral infection caused by type 3 vaccine virus in a recipient of oral polio vaccine, widespread spinal form, lower paraparesis,” and the child was recognized as disabled.A forensic medical examination carried out during the consideration of the claim confirmed the existence of a cause-and-effect relationship between the actions of doctors and the deterioration of the child’s condition: vaccination was carried out in violation of clause 9.1 SP 3.1.2951-11 “Prevention of Poliomyelitis”, Order of the Ministry of Health of the Russian Federation dated March 21, 2014 No. 125n, where it is stated that the first vaccination against polio is carried out with a vaccine for the prevention of polio (inactivated), and the pediatrician prescribed a live polio vaccine, which is regarded as a defect in the provision of medical care. Moreover, the boy’s general blood test showed signs of eosinophilia, which could indicate a decrease in immunity, and a slight increase in the erythrocyte sedimentation rate - one of the signs of the body’s inflammatory response. All this could contribute to a decrease in the child’s immunity and, as a result, to his illness with polio as a result of vaccination, since under normal conditions the live polio vaccine does not cause such complications, but only if the patient has immunopathological conditions. The guilty medical workers were subject to disciplinary action.
In the Tyumen region, the court ordered to pay 800,000 rubles to the mother of a child who, a year and a half after birth, became disabled due to a vaccination that he should not have received (decision of the Ishim City Court of the Tyumen region dated February 20, 2014 in case No. 33-2200/2014 ).
The claim was filed by the mother of a baby who was vaccinated against tuberculosis on the third day after birth. A year later, the parents discovered that the boy stopped leaning on his right leg when trying to walk. Examinations showed that he had tuberculous right-sided coxitis of the hip joint. In January 2011, the child was operated on, and in April of the same year he was declared disabled.
In allowing the stated demands, the court proceeded from the fact that the vaccination was carried out by the defendant in violation of Art. 32 Fundamentals of the legislation of the Russian Federation on the protection of the health of citizens” dated July 22, 1993 and Part 1 of Art. 5 of the Federal Law “On Immunoprophylaxis of Infectious Diseases” dated September 17, 1998 No. 157-FZ. According to these standards, a necessary precondition for medical intervention is the informed voluntary consent of the citizen. The court found that the mother was not explained the possible complications when vaccinating her child. In addition, the woman had an intrauterine infection, which was a contraindication for vaccination.
As you can see, if a doctor vaccinates despite existing contraindications, or does not inform parents in writing about possible adverse consequences, he is responsible for this.
Imaginary victims of vaccination who make demands to recover compensation for lawsuits from the state and medical organizations (decision of February 7, 2013 of the Karasuksky District Court of the Novosibirsk Region in case No. 2-3/2013; decision of March 3, 2014 of the Ingodinsky District Court Chita (Trans-Baikal Territory) in case No. 2-446/2014) or vaccine manufacturing companies (for example, the unsatisfied claim in the MMR scandal amounted to 14 million pounds sterling).
Thus, in the Kurgan region, the court refused to collect 700,000 rubles of moral damages from the medical organization from the mother of the child, since there was no sufficient data indicating a violation of professional standards and rules for the provision of medical care and treatment (decision of the Kurtamysh district court of the Kurgan region dated March 26, 2009 . in case No. 2-3/2009).
In support of her claims, the mother of the minor referred to a violation of the technique of BCG vaccination, which was administered to her child on the day of discharge from the maternity ward of the hospital. After 5 months, she discovered a tumor on the back of her daughter’s head, the child’s condition gradually began to deteriorate, and a series of operations followed. A diagnosis was made of tuberculous axillary lymphadenitis. As part of this case, forensic medical and commission forensic medical examinations were carried out, the conclusions of which did not establish a cause-and-effect relationship between the quality of medical care and the development of complications in the child.
The appearance of pathological processes in the form of lymphadenitis in children in the post-vaccination period does not in itself mean the presence of a direct causal relationship between vaccination and the development of pathological processes, because the latter can arise as a result of the provoking effect of vaccinations, during exacerbation of chronic diseases, “revival” of a latent infection, or in the presence of a concomitant infection, which can change and aggravate the body’s response to vaccination. The absence of characteristic complications and their consequences in the form of a “cold abscess” (dense infiltrate at the site of vaccine administration, as a result of subcutaneous administration), or a keloid scar at the site of vaccine administration indicates compliance with professional vaccination standards. The examination did not establish any violations during vaccination, and the diagnosis “tuberculous axillary lymphadenitis on the left” made at the medical institution does not have sufficient objective justification.
Thus, the court came to the conclusion that the senior midwife of the maternity ward of the Kurtamysh Central District Hospital did not violate the vaccination technique when inoculating with the BCG vaccine, and also that the only reason for the complication in the child in the form of tuberculous axillary lymphadenitis on the left was not a violation of the vaccination technique (administration of the BCG vaccine under skin instead of intradermal injection), as well as there is no evidence that there were other actions of the medical staff of the Central District Hospital that were causally related to the disease the child received.
In 2021, the Ramensky District Court of the Moscow Region denied the child’s mother compensation for moral damages in the amount of 3,000,000 rubles (decision of the Ramensky City Court of the Moscow Region dated April 5, 2021 in case No. 2-5823/2017). In support of the requirements, the child’s mother indicated that her son, at the age of 6 months, was diagnosed with the consequences of vaccine-associated poliomelitis, flaccid paresis of the right lower limb. The child has been disabled since childhood and is deprived of the ability to move independently. She believed that the child’s illness was in a direct cause-and-effect relationship with the polio vaccination given to him by doctors at the Bronnitsy City Hospital in 2004.
During the trial, a forensic medical examination was carried out, according to the conclusion of which it was established that before the vaccination there were no objective or subjective reasons for medical withdrawal, no defects in the provision of medical services were identified, and there was a cause-and-effect relationship between the polio vaccination and the complications that arose in the child were not established.
Moreover, the expert commission, on the basis of the presented medical documentation, established that the post-vaccination consequences that developed in the child in the form of flaccid paresis of the right lower limb with its shortening were the result of the parents’ voluntary refusal of the proposed treatment and timely hospitalization of the child, self-medication of the child and failure to comply through the fault of the parents themselves in the subsequent period, all procedures prescribed to the child in full.
Thus, fueled and multiplied by numerous anti-vaccination myths, parents’ fears lead to unfounded lawsuits and the desire to punish with rubles medical organizations that “harass the health of children for the sake of profit.”
Vaccination in the absence of informed voluntary consent
Vaccinations are always an intervention in the body, and there are contraindications recognized by doctors when they are prohibited. The pediatrician is obliged to list these cases to parents, warn about the adverse effects of vaccination, and must also sign informed consent from the parents, and only after that vaccinate the child. This procedure is provided for in Part 1 and Part 7 of Art. 20 Federal Law “On the fundamentals of protecting the health of citizens in the Russian Federation” No. 323-FZ. Even if a quarantine is declared in a region or city in the midst of an epidemic, no one has the right to force or without consent to vaccinate a child (clauses 1 - 2 of Article 5 of Federal Law No. 157-FZ). However, as experience shows, doctors, in an effort to protect the child, forget about the possible legal consequences of such good intentions, which in turn leads to the possibility of holding medical workers accountable for violating the requirements for obtaining IDS.
Thus, the Ussuriysk City Prosecutor's Office of the Primorsky Territory, during an inspection of a complaint from the mother of a primary school student in the village of Timiryazevsky, found that at the end of 2015, employees of the structural unit "Outpatient Clinic" of the regional state budgetary healthcare institution "Ussuriysk Central City Hospital" (hereinafter referred to as the KGBUZ) carried out vaccination of students of a secondary school in the village of Timiryazevsky, while the diagnosis of 2nd grade students was carried out without the informed voluntary consent of the children’s legal representatives for medical intervention and even though one of the students had a written parental refusal of all preventive vaccinations in their medical records. On these illegal facts, the prosecutor of the city of Ussuriysk made a presentation to the chief doctor of the KGBUZ.
In this part, Law No. 323-FZ contains unambiguous requirements that are subject to strict execution. Meanwhile, the situation requires a more panoramic analysis - from the position of ensuring the safety of other children in whose company there will be a person who has not undergone, for example, medical diagnosis for the presence of dangerous infectious diseases or mental disorders, as well as protecting, if necessary, the rights and legitimate interests of the children themselves from unjustified decisions and actions of their legal representatives.
Indeed, it would be unreasonable to make the observance of public interests in such a sensitive issue as health protection completely dependent on the individual preferences of individuals. A similar position is taken by the Constitutional Court of the Russian Federation, which indicated in the constitutional interpretation of the meaning of certain provisions of the legislation that the rights and legitimate interests of a person and a citizen do not have an absolute (overwhelming) nature and are balanced by the presence in the legislation of various compensating legal mechanisms that are designed to ensure the full implementation of these rights and interests and at the same time the protection of constitutionally significant values, the safety of the entire society (resolution No. 2-P dated February 10, 2017, No. 8-P dated March 17, 2017, etc.).
Based on this, the right to refuse vaccination does not mean that the person who refuses will not face negative consequences of his decision - which can be both medical (increased risk of contracting a particular infectious disease) and legal. However, the negative legal consequences for those who refuse vaccination is a separate, extensive issue, which we discussed in detail in our analytical article “Legal consequences of refusing vaccination.”
After the incident with Mantoux samples in Primorye, schools are collecting parental permission for medical intervention
After the incident in Primorye with Mantoux samples, the Ministry of Health began urgently collecting parental permission for medical intervention in schools. According to the all-Russian public organization for family protection “Parental All-Russian Resistance” (RVS), in some schools in the country they are beginning to collect so-called “informed consent” for medical intervention from parents. Representatives of the RVS encountered an illegal, in the opinion of social activists, gathering in Bryansk, Ulyanovsk, Smolensk and Tolyatti. Experts believe that such measures are related specifically to the recent incident in the Primorsky Territory.
