6 ASIAN LEGAL BUSINESS – INDIA E-MAGAZINE MAY-JUNE 2024 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 called 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. Another public interest litigation has been filed by an advocate before the Supreme Court seeking the creation of a medical board 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. 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 vaccinemakers. 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. 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.” u u COVISHIELD’S POTENTIAL LEGAL LIABILITY BY NIMITT DIXIT Explainer Deals $2.5 BLN Vodafone Idea’s further public offering Deal Type: ECM Firms: AZB & Partners; Cyril Amarchand Mangaldas; S&R Associates; Sidley Austin Jurisdiction: India $719 MLN Brookfield India Real Estate Trust’s acquisition of stake in Rostrum Realty Deal Type: M&A Firms: Cyril Amarchand Mangaldas; Khaitan & Co; Shardul Amarchand Mangaldas & Co Jurisdictions: Canada, India $556 MLN Warburg Pincus’s acquisition of Shriram Housing Finance Deal Type: M&A Firms: Anagram Partners; Cyril Amarchand Mangaldas; Trilegal Jurisdictions: India, U.S. $370 MLN Consortium’s investment in AG&P LNG Marketing Deal Type: M&A Firms: Cyril Amarchand Mangaldas; Latham & Watkins Jurisdictions: India, Japan $296 MLN Advent International’s investment in Apollo HealthCo Deal Type: M&A Firms: AZB & Partners; Cyril Amarchand Mangaldas; Shardul Amarchand Mangaldas & Co Jurisdictions: India, U.S. $220 MLN Indigene’s initial public offering Deal Type: IPO Firms: Cyril Amarchand Mangaldas; Shardul Amarchand Mangaldas & Co Jurisdiction: India u
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