Prakash Bang vs Glaxo Smithkline Pharmaceuticals Ltd. & Anr.
Background
The appellant took a repeat (third) dose of the Hepatitis-B vaccine Engerix-B along with his wife and two sons in 1998, administered by his family physician. Only the appellant developed shoulder pain and, eventually, a permanent disability, which he attributed to "myositis" caused by an adverse reaction to the vaccine; his family members who took the same batch had no reaction at all. He filed a consumer complaint before the National Consumer Disputes Redressal Commission (NCDRC) seeking roughly Rs. 90 lakh in compensation from the manufacturer, which the NCDRC dismissed for lack of proof of any drug defect or negligence.
Decision Breakdown
The Supreme Court upheld the NCDRC's dismissal, holding that the appellant had failed to discharge his initial burden of proving, even on a preponderance of probability, that he actually suffered myositis and that it was caused by the vaccine. The affidavits filed by his family doctor and his doctor-uncle were found to carry no real evidentiary value since they made bare assertions without any medical-record correlation, research, or expert basis, and the appellant had also failed to provide a muscle biopsy that the manufacturer had asked for to help establish causation. The Court also held that the vaccine manufacturer's failure to list myositis as an adverse reaction did not amount to "deficiency of service," since the reaction, per the manufacturer's global safety data, occurred in only about 0.02 per million doses: too rare and unproven in this specific case to establish negligence.
Lesson Learnt
In consumer complaints alleging harm from a medicine or vaccine, the burden is on the complainant to establish, with real medical evidence (records, tests like a requested biopsy, or genuine expert opinion), both that the claimed injury occurred and that the product caused it: vague, unsupported doctor affidavits and the mere fact that symptoms followed treatment are not enough.