The world’s largest vaccine producer as measured by volume, Pune-based Serum Institute of India (SII), has found itself in a potential lawsuit in India due to the claim from a 40-year-old volunteer for the ‘Covishield’ COVID-19 vaccine study that the investigational product triggered a neurological impairment that’s led to an inability to get back to a normal life since the inoculation. The plaintiff, who was seen at a trial site location at Chennai’s Sri Ramchandra Institute of Higher Education and Research, had attorneys send legal notices to Serum Institute of India as well as the study’s ultimate sponsor AstraZeneca and even the original maker of the vaccine Oxford Vaccine Group. Involving 1,600 volunteers, the Covishield study in India has apparently completed recruiting patients. The trial site organization’s ethics committee concluded that the adverse reaction was not associated with exposure to the vaccine candidate and communicated these findings to the Drugs Controller Genera India (DCGI), India’s drug regulator. Although Serum Institute of India argues, the facts of the situation reveal that the volunteer is driven by outright malicious intent. The potential litigant nonetheless seeks compensation totaling Rs 5 crore (US$676,156) in addition to a halt in testing, manufacture, and distribution of the investigational product. The Serum Institute of India plans on hitting back hard, with exponentially higher damages claims in a counter lawsuit. This vaccine candidate, called Covishield in India but in the West known as AZD1223 or originally ChAdOx1 nCoV-19, was associated with a previous incident involving a study volunteer in the UK who purported experienced a neurological injury possibly associated with the clinical trial. The overall study was placed on hold for a few days in the UK and India and for several weeks in the United States while the U.S. Food and Drug Administration (FDA) looked into the matter. The study and associated investigational product was deemed safe, and hence, the FDA gave the green light to resume the trial in America, which continues on presently.
A Touchy Subject
The ‘Covishield’ study in India is actually based on the vaccine candidate developed originally by University of Oxford scientists and thereafter licensed by Anglo-Swede pharmaceutical giant AstraZeneca. In India, AstraZeneca partnered with the prominent Serum Institute of India, the world’s busiest vaccine manufacturer. Known as AZD1222, this investigational product was the subject of controversy in the UK back in September when a volunteer experienced some neurological issues purportedly associated with the clinical trial. Apparently, the UK-based study volunteer experienced symptoms that were strikingly similar to a serious inflammatory disorder known as transverse myelitis.
That event triggered a global pause of AstraZeneca’s Phase 3 COVID-19 vaccine trials; the UK, India and others resumed quickly, but the FDA looked into the matter for several weeks, delaying the study. The Gold Standard regulatory agency then allowed the trial to commence, declaring the situation was safe enough to proceed. Undoubtedly, the agency factored in global pandemic conditions in their risk-based analysis.
The Facts Appear to Differ Based on Point of View
The Hindu recently interviewed the primary investigator treating the volunteer, Dr. S.R. Ramakrishnan. Leading the Covishield study’s Chennai arm at Sri Ramchandra Institute of Higher Education and Research, Dr. Ramakrishnan told the news outlet that the “subject was now alright” but directed any further questions to the Serum Institute of India, the sponsor of this study in the world’s second-most populous nation. The potential plaintiff declares a very different reality.
The volunteer signed the study’s Informed Consent form on September 29, 2020, and proceeded to participate in the clinical trial with a jab on October 1. As reported in The Hindu, the Covishield vaccine, involving a double dose study, was randomized and controlled, with some volunteers receiving the vaccine candidate with others receiving a placebo 28 days apart.
As a test revealed the presence of antibodies in the volunteer, this was the “proof” according to the plaintiff that he received the Covishield vaccine and not a placebo. Just 10 days after the first jab, the plaintiff reported severe headaches and other symptoms such as vomiting and severe fatigue. But the plaintiff’s “legal notice” also declared that other behavioral changes and symptoms were present. For example, the notice litigants declared, “He showed irritation towards light and sound, and was resisting any effort to make him get up from bed.”
Hospitalization & Treatment
The study volunteer was apparently taken via ambulance to the Sri Ramachandra Medical College and Hospital emergency department. The Hindu’s reporters were able to view the hospital’s discharge summary, which included notes that the patient was “in an altered mental state” while also “disoriented.” He was hospitalized from October 11 to October 26. After a series of tests, he was moved to the Intensive Care Unit.
Not Fully Recovered
Now the patient’s wife reported to The Hindu that he is not fully recovered and, consequently, unable to go back to work, commenting, “We are consulting another neurologist at the Apollo Hospital, and his tests confirm dysfunction in the brain. He is recovering slowly and is better than what we were , but he is unable to work as before, and he is passionate about his work.”
Trial Site Principal Investigator Point of View
Dr. Ramakrishnan, again with Sri Ramchandra Institute of Higher Education and Research and the investigator at the Chennai arm of the Covishield study, shared that from his observation, the patient was recovering, noting, “He recovered very well and we treated him as per protocol and he even came back for a follow-up. All the expenses were borne by the hospital,” the doctor continued.
Ethics Committee: Illness not Connected to Vaccine Candidate
According to Shubashree Desikan and Jacob Koshy, writing for The Hindu, the hospital’s ethics committee had concluded that the adverse reaction wasn’t associated with the vaccine candidate known around the world as AZD1222 but in India as Covishield. They communicated this finding to the Drug Controller General of India (DGCI), India’s equivalent of the FDA.
The Serum Institute of India is on record that while the prominent vaccine manufacturer is “sympathetic with the volunteers’ medical condition, there is absolutely no correlation with the vaccine trial and the medical condition of the volunteer.”
Highlighting the findings of the ethics committee, they went on to declare that this volunteer was “specifically informed by the medical team that the complications he suffered were independent of the vaccine trial he underwent.” Because the diagnosis led to the conclusion that the condition was not correlated whatsoever with the vaccine and that this was clearly communicated to the volunteer, the actual claims are malicious and subject to a major countersuit.
Serum Institute of India: False Allegations
Other Indian media picked up on the potential for false allegations and, consequently, noted the potential for a countersuit involving exponential damages against the Serum Institute of India. The National Herald of India reported on additional commentary that the study volunteer and potential plaintiff could very well not be acting in good faith but rather, as suggested by the Serum Institute of India, is engaged in “malicious and misconceived” activity based on lies and fabrications. From this point of view, the rationale is obvious: in an attempt to lay blame on others for his medical problems and gain a large sum of money, the clinical trial volunteer turned aggressive plaintiff.
Into the Courts?
In the United States, as in other common law countries, litigants can use the courts in a bid to extract payment for alleged civil wrongs. Often, the cost of fighting at what times can be predatorial forms of litigation isn’t worth any benefit. Hence, the settlement is secured—the plaintiff ends up getting paid despite their less than underlying noble intentions directing the litigation in the first place. While the hapless defendant essentially pays for the privilege of the bad actor to just go away. Attorneys take on these cases because they can charge 30% or more of the total settlement amount—what can become a lucrative sum.
Is this current situation in India a variety of this kind of legal scenario? Although The Hindu interviewed the plaintiff’s wife who told reports that he signed up for the clinical trial in the “spirit of public service” based on “categorical assertions” made that the vaccine was safe and would not cause serious reactions. This apparently convinced the plaintiff that the study was safe and to proceed with volunteering.
The volunteer appeared to become violently sick just ten days after the vaccine inoculation and was admitted to the emergency department at the same institution where the study occurred. According to the Serum Institute of India, he (the volunteer and now patient) was advised after a thorough medical analysis that his health issue wasn’t associated with the study vaccine candidate. However, the volunteer didn’t take the institution’s diagnosis to heart and consequently went ahead and apparently filed an action.
Serum Institute of India plans on countersuing the litigant in the amount of over $13.5 million (Rs) 100 crore in a bid to defend the organization’s good name. They believe the potential plaintiff is attempting to tarnish their good name, evidenced by a clear attempt to spread malicious information, driven by “oblique pecuniary motive.”
Standard SAE investigating
The Economic Times in India reported that a standard process is followed for any serious adverse event finding during a clinical trial. India’s apex research agency, Indian Council of Medical Research (ICMR), has been appraised of the situation and will continuously monitor things, reports Samiran Panda, head of epidemiology and communications. However, the only agencies responsible for the investigation are the institutional ethics committee (at the hospital) and India’s drug regulator known as DCGI.
ICMR’s Mr. Panda was quoted, “Any SAE needs to be examined for their causal association or link with the vaccine or the investigational product. In any trial, that is the way to go, and the institutional ethics committee of the institute, which were responsible for the site-specific vaccine administration would give the report within 48 hours to the drug controller. Adverse events do happen and SEA also happens but all over the world, it is the causal link which needs to be assessed.”