SC Dismisses Plea Alleging Deficiency in ‘GlaxoSmithKline Pharma’ Hepatitis Service

The Supreme Court has dismissed a plea by a man against an order of the National Consumer Disputes Redressal Commission (NCDRC). The NCDRC had determined that he had failed to prove a deficiency in service on the part of GlaxoSmithKline Pharmaceuticals Ltd concerning the administration of a hepatitis vaccine.

According to the case, the man sought immunity against Hepatitis B and approached his family physician for the repeat dose of the Engerix-B vaccine, along with his family members. While the family members experienced no adverse reactions to the vaccine, the appellant experienced severe pain in his left shoulder at the injection site four days after being vaccinated. He also suffered pain when moving his shoulder and developed myositis.

The appellant argued that the vaccine Engerix-B, manufactured by Glaxo, had caused a sudden permanent disability in his shoulder.

A bench comprising Justice A S Bopanna and Justice Prashant Kumar Mishra noted that drugs like Engerix-B are available in the market only after certification. There was no evidence to suggest that this drug was available “over the counter,” without a prescription.

The bench also raised questions about the administration of the vaccine to all family members and whether it had been administered correctly and at the appropriate site. It suggested that the family doctor who administered the vaccine should have been a party to the proceedings.

The apex court stated that the absence of myositis as an adverse reaction in the literature accompanying the injection or on the vial did not constitute a “deficiency of service” on the part of the pharmaceutical company.

The bench concluded that the appellant had not provided sufficient evidence to establish, even on a preponderance of probability, that the Engerix-B vaccine was the cause of his myositis.

The Supreme Court considered a plea by the appellant challenging the NCDRC’s order.

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