Qobalia v. Ministry of Labour, Health and Social Affairs

The plaintiffs alleged violations of the statute on the Protection of Consumers’ Rights for the failure of the respondents to develop standards of evaluation regarding imported vaccinations and the failure to notify the public about the risks associated with the imported vaccinations.

G. Qobalia was a 12 year-old healthy child. He was vaccinated against Hepatitis B using a vaccine that was imported from Korea by UNICEF as part of a humanitarian mission. On the third day after the vaccination, Qobalia suffered from paralysis of the upper and lower limbs and fell into a coma. A later examination diagnosed him with encephalomyelitis.

Plaintiffs claimed a violation of section 2 of article 3, and sections 1 and 2 of article 6 of the statute on the Protection of Consumers’ Rights, due to the vaccine not being labelled with any potential side effects. If there had been proper notice, the parents claimed they would not have allowed their child to take the vaccination. They contended that the respondents, the Disease Control and Medical Statistics National Center and the Ministry of Labour, Health and Social Affairs, acted negligently. Specifically, they had not developed a safety standard developed for the vaccine and had not delayed its sale until the standard was established.

The plaintiffs sought payment for Qobalia’s damages and prohibition on the import and sale of the vaccine. The respondents claimed that there was no strong link between the vaccination and the disease, therefore the plaintiff’s application should not be satisfied.

The circuit court held the respondents were liable to pay as the causal relationship between the vaccination and the consequence was established. The court found a causal relationship as encephalitis was one of the possible side-effects of the vaccination. The court required a one-time payment of 1000 GEL and 50 GEL monthly until 1 June 2054.

The Court held that the decision of the circuit court was to be changed to increase the amount of compensation for the plaintiff and to include “Green Cross Vaccine Corporation” as one of the parties liable for the amount awarded in the judgment.

The Court held that there was in fact a causal relationship between the vaccination and the consequences suffered. The Court notes the reports from a children’s hospital and two clinics both that point to the vaccine as the cause. The relationship was not excluded because of a lack of data about the exact biological mechanisms that caused the harm. Based on this, the Court found that the existence of damage itself gave rise to the obligations of the respondents.

The Court did not agree with the circuit court in releasing “Green Cross Vaccine Corporation” from liability. The damage was caused by their inactivity in failing to provide notification of the potential side-effects of the vaccination. Therefore, liability should be imposed on “Green Cross Vaccination Company”, the Ministry of Labour, Health and Social Affairs of Georgia, and the Disease Control and Medical Statistics National Center jointly.

“[T]aking into account the fact that the Ministry of Labour, Health and Social Affairs’ object is the development of state health and strategic-prophylaxis governing; implementation and development of state medical standards; provision of safe environment for human health – the Ministry had an obligation to study and analyze the information which existed for that period on Hepatitis B vaccinations and to deliver it to the population in order to minimize the harmful results and provide information on possible results for the child’s legal representatives.” Page 4.

“With section 2 of article 3 of the Statute on Consumers Rights a consumer has the right to know that the product’s preservation, transportation and its use in common condition is harmless to one’s life, health and environment in addition to not being harmful to his/her property. According to section 1 article 6 of the same statute the manufacturer has an obligation to deliver necessary and true information about the product which will give the consumer a proper choice. By section 2 of article 6 the information about products should contain the notice on harmful substances and its side effects in case of particular diseases.” Page 6.