The Supreme Court, while upholding an order of the National Consumer Disputes Redressal Commission (NCDRC) that the Appellant-Petitioner was not able to establish the minimal evidence required to prove a preponderance of possibility of his case, has held that while cross-examination similar to that in Civil Court would not be followed in summary procedures before the NCDRC, it would be permissible in normal circumstances to file interrogatories related to statements made in an affidavit. The Court, however, held that the failure on the part of the Appellant to adopt that course of action to discredit an expert opinion against him was not detrimental to his case.

The Court dismissed a Civil Appeal filed by an individual claiming that the suffered from ‘myositis’ due to an adverse reaction to the vaccine Engerix-B and challenging the order of the NCDRC. The NCDRC had dismissed his claim seeking Rs. 90 lakh as compensation from the Respondent company that formulated the Engerix-B vaccine.

"In the instant case, though in the summary procedure before the NCDRC the cross-examination in the nature as done in the Civil Court would not be followed, it is no doubt true that in a normal circumstance it would be open to file interrogatories relating to the statements made in the affidavit", the Bench of Justice AS Bopanna and Justice Prashant Kumar Mishra held.

The Court noted that the Respondents provided a detailed affidavit outlining the certification process that the drug went through before it was released to the market. Additionally, the Court noted that there was no evidence suggesting that the drug was available without a prescription. The Court held that the family doctor who administered the vaccine had a responsibility to the patient and should have been aware of more information about the vaccination prior to giving it.

The Court noted that the burden of proof lies heavily on the Appellant to establish his case. Apart from the affidavit filed by the Appellant's known doctors, no other evidence was submitted to support his claim, the Court asserted.

The Bench held that, “Therefore in the facts on hand, if the matter is looked at from its correct perspective it is seen that except for the appellant assuming that he has suffered ‘myositis’ and the cause for the same was the Engerix-B vaccine being administered, the same has not been established with the minimal required evidence to conclude even on preponderance of probability. That apart, as noticed, even muscle biopsy which was required by the respondents was not furnished so as to enable the respondents to take an ultimate decision in the matter. As such the appellant cannot be heard to complain that the respondents have not attempted to redress his grievance”.

Senior Advocate Anita Shenoy appeared for the Appellant, and Advocate Ujjwal A. Rana appeared for the Respondent.

The Appellant sought protection against Hepatitis B and went to see his family doctor. Both the Appellant and his family members received multiple doses of the Engerix-B vaccine. However, the Appellant later filed a complaint with the NCDRC, praying for compensation of Rs 90 Lakh, alleging that the vaccine caused a severe allergic reaction leading to myositis. The NCDRC dismissed the complaint. Aggrieved by the order, the Appellant approached the Court by way of a Civil Appeal.

The Appellant contended that he had received four single-dose vaccines. Although his family members had no adverse reactions, the Appellant experienced severe pain in their left shoulder four days after receiving the injection. The Appellant claimed that he suffered a permanent disability in their shoulder as a result of an adverse reaction to the vaccine, which the Respondent manufactured. This disability affected his work as the Chief Executive at M/s Quicksel Communications.

The Court noted that the issue to ascertain was "whether there is enough evidence to prove that the Appellant actually suffered from 'myositis' and if the cause of this condition was the administration of the Engerix-B vaccine And whether the non-disclosure of 'myositis' as an adverse reaction in the vaccine literature or vial can be considered a deficiency of service".

The Court observed that it was unclear whether the doctor advised and prescribed the vaccine. As the Appellant's family did not experience any discomfort until after the final vaccine dose, the Court emphasized on the careful examination of evidence. The Court held that the burden of proof lies heavily on the Appellant to establish their case.

The next aspect for consideration would be as to whether the non-mentioning of ‘myositis’ being suffered as an adverse reaction in the literature accompanying the injection or on the ‘vial’ amounts to ‘deficiency of service’, more particularly when the adverse reaction was minimal only to the extent of 0.02 in one million. On this aspect, at the outset we note that the affidavit filed on behalf of the respondents would indicate the detailed procedure that is followed for certification of the drug. It is only after such certification the drug is available in the market. Nothing has been placed on record to indicate that this is a drug which was available ‘of the shelf’, without prescription”, the Bench noted.

After reviewing the evidence, the Court held that the Appellant's assertion of experiencing 'myositis' as a result of the Engerix-B vaccine lacked sufficient proof. The Appellant cannot argue that the Respondents failed to address his concerns since he did not submit the required muscle biopsy report.

Accordingly, the Court dismissed the Appeal and affirmed the impugned order.

Cause Title: Prakash Bang v Glaxo Smithkline Pharmaceuticals Ltd. & Anr. (2023 INSC 794)

Click here to read/download Judgment