Human Rights Commission orders Rs 20 lakh payout for administration of expired hepatitis B vaccine

Regarding the Research Fellow at the ART/COE unit of the hospital, the Commission observed that "though doctor Dr *** was later suspended from service, mere suspension does not absolve the liability of the authorities or the institution in granting adequate compensation to the affected individuals."

The history of the case goes back to 2014. Altogether, 16 victims were administered expired vaccines, and six of them later deposed before THRC and reported side effects such as "mental tension, giddiness, drowsiness, stomach pain, body pains, etc."

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They had urged the Commission to conduct a thorough inquiry and take action against the concerned Research Fellow, Dr. ***, and do justice. As per the latest media report by the South First, taking cognisance of the issue, THRC on 16th September 2014 had sought a report from the Superintendent of Gandhi Hospital. Subsequently, the report noted that the vaccine pack had "two different dates, one for expiry and one for syringe". It mentioned that the doctor, "by oversight, administered expired vaccines to the complainants."

Hospital Denies Negligence: 

In its report, the hospital had denied the allegations of negligence and blamed the manufacturer of the vaccine for the error. It mentioned in the report that "it is wrong on the part of the manufacturer to print the two different dates on the vaccine pack. Equally, the dealer of the drug is also responsible for supplying expired vaccines."

"After administering the expired vaccines, Dr *** realised her mistake and immediately informed her superiors. The subject incident was not intentional and there is no negligence on the part of the said doctor," it mentioned.

Further, the report mentioned that the vaccine was "of low potency and hence, there will be no side effects," and it also expressed doubt on the severity of the complainants' symptoms highlighting that the complainants continued attending work regularly.

Apart from this, the report also alleged that "boring grudge against the said doctor, the complainants have filed the subject complaint with baseless allegations." The hospital also cited shortages at the ART/COE as a contributing factor to the situation. 

Response from Complainants: 

Reacting to the Superintendent's report, the complainants mentioned that "it is the bounded duty of the medical officer or the doctor to check the expiry date of the drug before administering it to the patients and failure on their part in doing so would certainly constitute a negligent act."

They also emphasised that they had "suffered mental agony due to the negligent act of Dr ***."

Consequently, on 13 August 2015, the complainants submitted a memo to the Commission along with a vaccine wrapper – ‘Elovac-B’ Hepatitis Vaccine.

Later, the case was tagged with another issue for which the Commission had taken suo motu cognisance based on a newspaper report alleging irregularities in the supply of medicines at Gandhi Hospital. For this, the Commission had directed the Deputy Commissioner of Police, North Zone, Hyderabad City, to inspect the drugs at Gandhi Hospital.

THRC had also recorded that "the then Secretary & CEO of this Commission, along with the Deputy Registrar visited Gandhi Hospital on 14.08.2015" and made suggestions to improve the hospital facilities.

It was also noted by the Commission that the doctor was subsequently suspended from service.

Systemic Failure, notes Commission: 

The Human Rights Commission found the hospital's report on the incident "do not inspire confidence and does not satisfactorily address the core issue of administering expired vaccines to the complainants."

It also stressed that "it is the basic and non-negotiable duty of every medical officer to verify the validity of the drug before administering it to the patient. Claiming oversight in such a sensitive matter is unacceptable, particularly when it directly concerns the safety of the patients."

Further criticising the hospital's claim alleging that the vaccines were of low potency, the Commission called it "medically unfounded and undermines the seriousness of the issue."

Referring to the hospital's claim, the Commission termed it "the attempt to shift the onus onto the manufacturer and dealer, without fixing the accountability within the hospital system, reflects a systemic failure."

Noting that the complainants' right to health had been severely jeopardised, the Commission noted that the complainants were "subjected to unsafe and negligent medical practices leading to physical complications, severe health issues and mental anguish."

Accordingly, the Commission concluded that "the negligent act of Dr ***, besides the negligence of all higher-ups, clearly demonstrates lack of due diligence and quality control within the hospital", and that the Superintendent's report was "perverse and written with ulterior motives to save himself and other doctors."

Noting that the victims reiterated the "health issues and their long suffering" due to the expired vaccines, the Commission held that "the Government of Telangana is vicariously liable for the acts and omissions of the subject hospital authorities."

Directions to Prevent Similar Incidents in the Future: 

Apart from granting compensation to the victims, THRC also made several recommendations under Section 18 of the Protection of Human Rights Act, 1993.

It directed the hospital authorities to ensure that they "do not receive medicines which are likely to expire within a short duration, and further direct the concerned not to take delivery of expired medicines."

Further, the Commission noted that the Suppliers must also be instructed "to print the date of expiry of the medicines at a conspicuous place on the wrapper as well as on the medicine, to avoid any misuse/maladministration of medicines."

In its order, the Commission has directed that all recommendations are to be implemented within two months from the receipt of the order.

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