EXPLAINER: Does Covishield’s alleged health concerns expose it to legal liability?

COVID-19 vaccine-maker AstraZeneca was in the spotlight in May following the company’s admission in a UK court proceeding of the possibility of a rare side effect, Thrombosis with Thrombocytopenia Syndrome (TTS) associated with its vaccines. More than 50 individuals have alleged the vaccine resulted in death and serious injuries from TTS.

Soon after this information went public in India, a lawsuit was filed against the Serum Institute of India (SII), which manufactured AstraZeneca’s vaccine in the country. The case was filed by the parents of Karunya, who had died after taking the shot in 2021.

Another public interest litigation has been filed by an advocate before the Supreme Court of India seeking the creation of a medical board, under the purview of a former Supreme Court judge, to examine the potential adverse health effects caused by the vaccine.

Lawyers feel this could just be the start of an array of potential litigation against AstraZeneca and SII, particularly owing to the absence of legal ramifications for filing frivolous and meritless claims.

WHAT KIND OF CASE CAN BE MADE?

There are multiple options for victims, representative bodies, local associations, concerned persons and the government to initiate action against AstraZeneca and SII, says Himanshu Vidhani, a partner in Chandiok & Mahajan’s dispute resolution practice.

Victims can file a product liability class action case against the vaccine makers under the Consumer Protection Act, 2019, seeking damages for the defective vaccine. A complaint can also be made under the Drugs and Cosmetics Act against the manufacturer and approving authority.

Vidhani adds that the companies may also be subject to public interest litigation before writ courts seeking investigation into the health effects of the vaccine, and potentially seeking directions to the Centre to establish a damage payment mechanism for those who became severely disabled as a result of a vaccination drive during the pandemic.

HOW IMPORTANT WAS THE UK VERDICT?

But Vidhani is quick to caution that an admission in a UK court, as reported in the press, will not be enough evidence in Indian courts to make a case against the vaccine-makers. Cases will need to be proven by complainants on their own merits with concrete evidence of correlation between the vaccine dose and cases of health effects, or death. Impact assessment, both actual and potential, of an allegedly faulty vaccine will also need to be done. Over 1.75 billion doses of Covishield were administered in India.

The standard to establish criminal charges is even higher with the mandatory requirement to prove criminal intent, adds Vidhani. This may involve the disclosure of communication and pre-market test results to see if the manufacturers knew of the alleged side effects associated with the vaccine, and, if so, what steps were taken to mitigate such risks.

Medical negligence is another challenging prospect, given the urgency to produce a vaccine and potential impact it had in saving lives would likely outweigh the adverse effects the vaccine may have had on a small number of consumers.

What defence can AstraZeneca and SII take?

The vaccine companies will likely defend their actions on two grounds, explains Vidhani: The first is a medical argument, that while the drug may have had adverse effects on a few, it was necessary to circulate them quickly in larger public interest. On balance, the vaccine’s urgent need outweighed any potential ramifications.

The second would be that the incidence of TTS among vaccine users is extremely minuscule. In the UK court admission, AstraZeneca has said TTS may occur only in “very rare cases.”

SII can additionally argue that any potential adverse impact was not disclosed to it, although this may open another can of worms – should the government and SII conducted their own independent analysis of the Covishield vaccine to examine any potential side effects.