A Landmark Ruling: India’s Supreme Court Addresses Post-Vaccination Adverse Events
The journey for families seeking answers and accountability following severe adverse events after COVID-19 vaccinations has reached a significant juncture in India. The nation’s Supreme Court has mandated the establishment of a system to compensate individuals who experience serious health issues post-immunisation, a move that offers a glimmer of hope to those grappling with loss and unanswered questions.
For Rithaika Sri Omtri, a bright 18-year-old with dreams of becoming a renowned architect, a persistent headache was the first sign of a devastating turn of events. What began as a mild discomfort escalated rapidly, progressing to tingling in her fingers and ultimately leading to a coma. Her mother, Rachana Gangu, recounted the harrowing experience, describing Omtri’s constant pain and persistent vomiting. By the time doctors in Hyderabad performed an MRI, it was too late. A massive brain haemorrhage had occurred, a stroke so severe that Omtri slipped away within hours.
Omtri’s illness began in June 2021, coinciding with India’s rollout of its COVID-19 vaccination program. She had received a dose of Covishield, the Indian version of the Oxford University-AstraZeneca vaccine, just days before her symptoms manifested. Tragically, she passed away on June 20, 2021.
While Omtri’s case represents a severe adverse event, it’s crucial to note that such occurrences were exceptionally rare within India’s vast vaccination drive. Across the administration of 2.2 billion doses, only 2,782 cases of side effects leading to severe illness were reported, equating to approximately one in 800,000. The number of fatalities following immunisation was even lower, at 1,171 cases.
However, these statistics offer little solace to families like Omtri’s, who have not only endured profound grief but also a prolonged struggle for recognition, answers, and accountability. This arduous pursuit has now culminated in a landmark order from India’s Supreme Court.
A “No-Fault” Framework for Compensation
The Supreme Court has directed the Indian government to implement a system where patients or their families can receive compensation for serious adverse events following COVID-19 vaccinations. This proposed “no-fault” framework aims to streamline the process by not requiring families to prove negligence or for the state or healthcare providers to admit wrongdoing.
Justices Vikram Nath and Sandeep Mehta, in their ruling, observed that India lacked a uniform or structured policy mechanism for redressal in such situations. They highlighted that this gap could not be overlooked, especially when vaccination programs are undertaken as public health measures under state authority. The concern becomes even more pressing given the unprecedented scale of immunisation during the COVID-19 pandemic, undertaken as a collective societal necessity.
Despite the promise of compensation, a central question remains for families like Gangu’s: will any amount be truly enough to alleviate their suffering and loss?
The Path to Vaccination and Unforeseen Risks
In early 2021, as India navigated the first wave of the pandemic, vaccination was presented as the primary pathway back to normalcy, a means to escape lockdowns, loss, and pervasive uncertainty. Omtri, who had just turned 18, was at a pivotal moment in her life, contemplating higher education in India and the United States. Her acceptance into Georgia Tech underscored her ambition to become a successful architect.
While vaccination was technically optional, it was practically a necessity for Omtri to pursue her educational aspirations, with colleges and international travel requiring immunisation. Gangu recalls being assured by at least three physicians that the vaccine was entirely safe, with no foreseeable issues. As a healthy young individual, the possibility of adverse side effects had never crossed their minds.
Omtri received her first dose of Covishield on May 29, 2021. When she fell ill a few days later, Gangu notes that even medical professionals were initially unaware of a potential link to the vaccine, attributing her symptoms to other causes.
Escalating Symptoms and Emerging Scientific Context
As Omtri’s condition deteriorated, blood tests revealed a drastic drop in her platelet count, far below normal levels. Doctors suspected dengue, but her rapid decline continued. The stroke that ultimately proved fatal followed.
Subsequent studies began to shed light on cases like Omtri’s. A study published in the British Medical Journal in August 2021 confirmed an association between certain COVID-19 vaccines and an increased risk of rare blood-related conditions, including potentially dangerous clots known as thromboembolism. The research indicated a higher incidence of venous clotting and low platelets with the AstraZeneca vaccine and an elevated risk of arterial clotting with the Pfizer shot.
It’s important to note that the same study highlighted that contracting COVID-19 itself posed a significantly higher risk of dangerous blood clotting than the vaccine. Public health experts consistently emphasised that the benefits of protection against the virus far outweighed the risks of extremely rare adverse events.
At the time, AstraZeneca acknowledged clotting as an “extremely rare side effect” and stated its commitment to exploring ways to mitigate this risk. A spokesperson for Oxford University mentioned their keen interest in new developments and investigations into potential causes for these very rare side effects, while also expressing reassurance from real-world effectiveness data.
Even earlier in 2021, concerns about blood clotting led some European countries, including Germany, France, Italy, Spain, and Denmark, to restrict or review the use of vaccines similar to Covishield.
In the Indian Supreme Court, government lawyers presented arguments that vaccines approved in India had undergone rigorous scrutiny by multiple expert bodies and that systems for monitoring adverse events were robust, decentralised, and transparent. They reiterated that serious side effects were extremely rare, with clotting events occurring at a fraction of a case per 100,000 doses. Furthermore, they claimed that studies by national health agencies had found no direct causal link between COVID-19 vaccines and sudden deaths.
Omtri never regained consciousness after her stroke. Following the devastating news of her brain death, her family faced the heart-wrenching decision of organ donation.
“The doctor said if we could donate her organs, somebody else would live,” Gangu recounted. “My husband told me, you’re the mother. You decide. If she can’t be with us, at least let her provide life to others.” The family agreed, and an autopsy, legally required before organ donation, was conducted. According to the family, it confirmed cerebral venous sinus thrombosis, a rare type of clotting linked to the vaccine.
While this confirmation brought clarity, it did not provide closure. The ensuing struggle involved difficulties in obtaining medical records from the hospital and a lack of information from district immunisation officers. It took multiple right-to-information requests for the family to finally receive a reply in November, stating that her death was indeed caused by the vaccine.
Health authorities typically do not publicly confirm causation findings in individual cases, and the classification of adverse events remains a complex issue. The Independent has reached out to AstraZeneca, the Indian health ministry, and the Serum Institute of India for comment.
The Supreme Court itself declined to delve into the scientific determination of causality in individual cases, deferring such matters to “domain experts.” The court cited extensive studies by the Indian Council of Medical Research and the All India Institute of Medical Sciences that, it argued, had “conclusively established no linkage between Covid vaccines and sudden deaths.” For families like Gangu’s, however, this distinction can feel abstract, leading to the poignant question: “Why are we hiding the facts? Don’t people have the right to know?”
A Broader Legal Challenge and Shared Grievances
This question became central to a broader legal challenge that extended beyond Omtri’s individual case. In Coimbatore, hundreds of kilometres away, a similar tragedy unfolded. Venugopalan Govindan lost his 20-year-old daughter, Karunya, a data science student and musician, after her vaccination. Govindan described her as having built “an accomplished life” and being “very charming, everybody remembers her fondly.” He now feels compelled to prevent others from enduring similar fates.
Like Gangu, Govindan found himself navigating what he described as an “opaque system.” He lamented the difficulty in even registering an adverse event, likening it to a “black hole” once reported. The government contended that adverse events could be reported through official channels and reviewed by expert committees. However, petitioners argued that in practice, the system was inconsistent, with cases being underreported, misclassified, or delayed. Their collective experiences formed the basis of the joint petition that led to the Supreme Court’s recent ruling.
India’s vaccination drive was immense, with nearly 2.2 billion doses administered by late 2022, according to government data presented in court. Approximately 92,000 adverse events were reported, including 1,171 deaths. The majority of recorded events were classified as minor, with only about 2,700 deemed serious or severe.
The petitioners pointed out that other countries had restricted vaccines like Covishield due to blood clotting concerns in 2021. Gangu summarised their core question: “Why didn’t our government inform the public?”
Government lawyers argued that India-specific data supported the safety and efficacy of COVID-19 vaccines. They also contended that differences in population, genetics, and epidemiology made direct comparisons with other countries difficult. Authorities insisted that decisions were guided by domestic data and expert reviews. The court ultimately avoided adjudicating on scientific causation, distinguishing between medical debates and legal remedies.
The Court’s Mandate and Lingering Concerns
Instead, the court focused on a critical systemic deficiency: India’s lack of a uniform, structured system for compensating individuals who suffered serious adverse events following vaccination, particularly within a nationally orchestrated program. The absence of such a mechanism, the court stated, could not be ignored.
Consequently, the court directed the government to establish a framework for affected individuals or families to receive financial compensation without the burden of proving negligence or liability.
Crucially, the court clarified that this scheme should not be construed as an admission of fault by the government or any authority. It also declined to establish an independent body to investigate adverse events, stating that existing expert systems should continue. Individuals, the court added, would retain the freedom to pursue other legal avenues, including consumer courts.
Gangu expressed dissatisfaction, stating that while she anticipated the ruling would not assign blame to the government, she had hoped for clearer directives on informed consent. She questioned the very meaning of compensation and whether individuals would possess the time or resources to pursue consumer courts if they were unsatisfied.
The “no-fault” framework is still under development, and key details remain unclear. Questions persist regarding how claims will be assessed, how compensation amounts will be determined, and the accessibility of the system for families across diverse socioeconomic backgrounds.
Govindan was more direct, calling the ruling “too little, too late.” He believes that in the absence of a functional system, the framework will not adequately serve all affected individuals.
For both families, the core issue transcends mere financial compensation. It is about recognition, transparency, and the restoration of trust. At the heart of this struggle lies a fundamental tension that characterised the pandemic years: the disparity between official public messaging and the lived experiences of individuals.
The affected families argue that government communication fostered an “effective compulsion” where vaccination, though officially voluntary, became practically indispensable for travel, education, and participation in public life. Gangu recalled being told that the only potential side effects were a mild headache and fever, manageable with paracetamol – advice that offered no help to her daughter.
Govindan framed the issue as one of transparency, asserting that individuals receiving vaccines should have been provided with a clearer understanding of the risks. He advocates for open communication, stating, “Don’t give only the rosy side and hide the negative side. Tell people the risks. Even if they are rare. And let them decide.”
Both families maintain that with fuller information, they would have made different choices. Govindan stated unequivocally that he would not have vaccinated his daughter if he had known then what he knows now.
Public health officials, however, have argued that clear and confident messaging is essential during a crisis to ensure widespread uptake and that scientific evidence ultimately supports the large-scale use of vaccination to reduce severe illness and death.
Regardless of the Supreme Court’s ruling and its eventual outcomes, the affected families continue to grieve. Gangu remains deeply affected by the loss of her daughter’s unfulfilled future. She insists that the legal battle was never about money but about her inability to remain silent. “If I don’t take action, who will?” she asks, her voice resonating with a pain that feels like a “bad dream.”
