Supreme Court Upholds NCDRC Decision, Says 'No Evidence of Defect or Negligence' in Vaccine Case

In a landmark judgment today, the Supreme Court of India dismissed an appeal against Glaxo Smithkline Pharmaceuticals Ltd., stating that there was "no evidence of defect or negligence" in the administration of the Hepatitis B vaccine Engerix-B. The appellant, Prakash Bang, had alleged that the vaccine led to an adverse reaction causing 'myositis' and permanent disability in his shoulder.

Justice A.S. Bopanna, in his judgment, noted, "The appellant is before this Court assailing the order dated 25.04.2012 passed by the National Consumer Disputes Redressal Commission, New Delhi ('NCDRC' for short). Through the said order, the NCDRC has held that the complainant has miserably failed to establish his case in regard to either any defect in the drug in question or any negligence amounting to deficiency in service on the part of the respondent who is the manufacturer of the drug."

The Court also emphasized the lack of documentary evidence to substantiate the appellant's claims. "As noted, there is no documentary evidence placed on record to indicate the very basic issue of the purchase of the vaccine and the same being administered," the judgment read.

The appellant had relied on affidavits from his family physician and his uncle, both doctors, to establish his case. However, the Court found these affidavits lacking in evidentiary value. "Except for the affidavit filed by the doctors known to the appellant, there is no other evidence available on record," the judgment stated.

On the issue of 'myositis' being a potential adverse reaction, the Court found it not to be a 'deficiency of service,' given the minimal incidence rate of 0.02 per million doses and the detailed certification procedure followed for the drug. "In any event, from the very details furnished by the respondents, the instance of 'myositis' being minimal to the extent of 0.02 in a million, to contend that there was negligence on the part of the respondent is also not acceptable," the Court observed.

The appeal was dismissed for lack of merit, upholding the NCDRC's decision. "We are of the opinion that the NCDRC has not committed any error so as to call for interference with the impugned order," concluded Justice Bopanna.

The judgment has set a precedent for similar cases involving allegations of medical negligence and consumer complaints against pharmaceutical companies.

Date of Decision: September 05, 2023

Prakash Bang vs Glaxo Smithkline Pharmaceuticals Ltd. & Anr.        

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