The Burden of Proof in Vaccine Adverse Reaction Cases: An Analysis of Prakash Bang vs. Glaxo Smithkline Pharmaceuticals Ltd.

Introduction

The case of Prakash Bang (s) v. Glaxo Smithkline Pharmaceuticals Ltd. And Another (s) (2023 INSC 794) adjudicated by the Supreme Court of India on September 5, 2023, addresses critical issues surrounding consumer liability, product safety, and the burden of proof in cases alleging adverse reactions to pharmaceutical products. The appellant, Prakash Bang, sought compensation alleging that the vaccine Engerix-B, manufactured by Glaxo Smithkline Pharmaceuticals, caused him to develop myositis, resulting in permanent disability. The case escalated from the National Consumer Disputes Redressal Commission (NCDRC), which dismissed the complaint, leading to the appellant's appeal to the Supreme Court.

Summary of the Judgment

The Supreme Court upheld the NCDRC's decision to dismiss Prakash Bang's complaint against Glaxo Smithkline Pharmaceuticals Ltd. The NCDRC had found that the appellant failed to provide sufficient evidence to establish a defect in the vaccine or negligence on the part of the manufacturer that could be attributed to his alleged adverse reaction of myositis. The Court emphasized the appellant's inability to substantiate the causal link between the vaccine administration and his medical condition, especially in light of the minimal incidence rate of myositis related to the vaccine and the absence of corroborative medical evidence.

Analysis

Precedents Cited

The appellant's counsel referenced several Supreme Court decisions to bolster the argument for compensation:

Malay Kumar Ganguly v. Dr. Sukumar Mukherjee (2009) 9 SCC 221: This case highlighted the reliability of notarized expert opinions when not contested by the opposing party.
Jacob Punnen v. United India Insurance Company Limited (2022) 3 SCC 655: Cited regarding the deficiency on the respondent’s part.
Chanda Rani Akhouri v. M.A. Methusethupathi (2022) SCC OnLine SC 481: Referenced for aspects related to negligence and deficiency of service.

However, the Supreme Court in Prakash Bang (s) v. Glaxo Smithkline Pharmaceuticals Ltd. found that these precedents were not directly applicable. The Court stressed the importance of factual and evidentiary context over rigid adherence to past judgments, especially in cases involving scientific causation and minimal adverse reaction rates.

Legal Reasoning

The Court undertook a meticulous examination of the evidence presented. Key aspects of the legal reasoning include:

Burden of Proof: The appellant bore the initial burden to establish both that he suffered myositis and that it was caused by the Engerix-B vaccine. The Court found his evidence insufficient to meet this burden.
Causation: Given the minimal incidence rate (0.02 per million doses) of myositis related to the vaccine, the Court required more concrete medical evidence to establish a direct causal link.
Evidence Evaluation: The affidavits submitted by the appellant’s family doctor and uncle lacked substantive medical testimony or data correlating the vaccine to myositis. The absence of a muscle biopsy further weakened the appellant's case.
Deficiency of Service: The non-mentioning of myositis as an adverse reaction in the drug literature was deemed insufficient to constitute a deficiency of service, especially given the rarity of the reaction and lack of evidence showing causation.

The Court also noted procedural lapses, such as the lack of cross-examination of the affidavits and insufficient medical documentation, which contributed to the dismissal of the complaint.

Impact

This judgment reinforces the stringent requirements for plaintiffs in product liability cases, particularly in establishing causation and overcoming the burden of proof. Key impacts include:

Strengthening Evidentiary Standards: Plaintiffs must present robust medical evidence and clear causal links to succeed in similar consumer disputes.
Clarification on Minimal Adverse Reactions: The case sets a precedent that extremely rare adverse reactions, especially those not widely recognized, may not suffice for establishing negligence or product defect.
Responsibility of Medical Professionals: The judgment underscores the duty of prescribing physicians to be thoroughly informed and judicious in administering vaccines, potentially increasing accountability.

Complex Concepts Simplified

Several legal and medical terms are pivotal to understanding this judgment:

Burden of Proof: The obligation of a party to prove their claims. In consumer cases, the plaintiff must demonstrate that the defendant's product caused harm.
Myositis: An inflammation of the muscles, which can cause muscle weakness and pain.
Causation: The requirement to show that the defendant's action directly caused the plaintiff's harm.
Deficiency of Service: Failure to meet the standard of service or product quality expected by the consumer.
Adverse Reaction: An unintended and harmful reaction to a drug or vaccine.
Affidavit: A written statement confirmed by oath or affirmation, used as evidence in court.

Conclusion

The Supreme Court's decision in Prakash Bang (s) v. Glaxo Smithkline Pharmaceuticals Ltd. And Another (s) underscores the critical importance of evidentiary rigor in consumer liability cases. By requiring substantial proof of both harm and causation, the Court ensures that compensation claims are founded on solid grounds. This judgment serves as a significant reference point for future cases involving alleged adverse reactions to medical products, emphasizing the necessity for detailed medical evidence and clear causal relationships. Ultimately, it reinforces the principle that while consumer protection remains paramount, the mechanisms for claiming redress must balance fairness with factual substantiation.