COVID-19 vaccine manufacturer AstraZeneca faced intense scrutiny in May after admitting in a UK court that its vaccine might cause a rare side effect known as Thrombosis with Thrombocytopenia Syndrome (TTS). More than 50 individuals have claimed that the vaccine led to deaths and severe injuries from TTS.
This revelation quickly led to legal actions in India. The parents of Karunya, who died after receiving the vaccine in 2021, filed a lawsuit against the Serum Institute of India (SII), which produced AstraZeneca’s vaccine locally. Additionally, an advocate filed a public interest litigation with the Supreme Court of India, requesting the formation of a medical board to investigate the vaccine’s potential adverse effects under the oversight of a former Supreme Court judge.
Lawyers anticipate that this could trigger a wave of litigation against AstraZeneca and SII, particularly given the lack of penalties for filing unfounded claims.
Himanshu Vidhani, a partner at Chandhiok & Mahajan’s dispute resolution practice, suggests that victims, representative bodies, local associations, concerned individuals, and the government have several legal avenues to pursue against AstraZeneca and SII. Under the Consumer Protection Act, 2019, victims can file a product liability class action case seeking damages for the defective vaccine. Complaints can also be lodged under the Drugs and Cosmetics Act against the manufacturer and the approving authority.
Vidhani notes that public interest litigation could be filed in writ courts to investigate the vaccine’s health effects and potentially direct the government to establish a compensation mechanism for those severely affected by the vaccine during the pandemic.
However, Vidhani cautions that the UK court admission alone is insufficient evidence in Indian courts. Plaintiffs must prove their cases with concrete evidence showing a direct link between the vaccine and adverse health effects or death. An impact assessment of the vaccine’s alleged faults will also be necessary. In India, over 1.75 billion doses of Covishield have been administered.
The standard for establishing criminal charges is even higher, requiring proof of criminal intent. This might involve revealing communication and pre-market test results to determine if the manufacturers were aware of the side effects and what steps they took to mitigate such risks.
Medical negligence claims pose another challenge. Given the urgent need for a vaccine and its significant role in saving lives, the benefits of the vaccine likely outweigh its adverse effects on a small number of individuals.
Vidhani explains that the vaccine companies will likely defend themselves on two grounds. First, from a medical perspective, they might argue that despite some adverse effects, the rapid deployment of the vaccine was necessary for the greater public good. The urgency of the situation justified the vaccine’s circulation despite potential risks.
Second, they may emphasize the rarity of TTS cases among vaccine recipients. AstraZeneca has stated in the UK court that TTS occurs in “very rare cases.”
SII might also argue that it was not informed of any potential adverse effects, raising questions about whether the government and SII should have conducted their independent analysis of the Covishield vaccine to identify potential side effects.
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