Supreme Court Refuses To Hold Pharma Company Liable For Not Mentioning Adverse Reaction Of Vaccination, Says Doctor Should've Advised Patient

The Supreme Court has upheld an order of the National Consumer Disputes Redressal Commission (NCDRC) where the Commission had held that no case of deficiency of service or defect was made out against drug-manufacturer, Glaxo Smithkline Pharmaceuticals Ltd, in relation to administration of vaccine Engerix-B.

It was the case of the complainant that he along with his family members had got the vaccine administered by their family doctor, and that the complainant had allegedly developed ‘myositis’ as an adverse reaction due to the administration of the vaccine.

Firstly, the Court noted that the complainant had failed to establish that he had suffered the adverse reaction due to the vaccination.

“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,” the bench of Justices A.S. Bopanna and Prashant Kumar Mishra said while dismissing the appeal.

The top court further held that non-mentioning of ‘myositis’ as an adverse reaction in the literature accompanying the injection or on the ‘vial’, did not amount to ‘deficiency of service’ on part of the pharmaceutical company, more particularly when the adverse reaction was to the minimal level, i.e., 0.02 in one million. Also, the court took into account the affidavit of the manufacturer which indicated that detailed procedure was followed in the certification of the drug.

The Court further noted that the drug was not available for administration without the doctor's prescription. Further, the court said the family doctor also owed a duty to his patient, adding that if the family doctor had prescribed the said drug, it was incumbent on him to know more details about the vaccination before prescribing or administering the same.

In view of the facts of the case, the court said, the allegations raised in the complaint would also make the said family doctor responsible and therefore, ideally, he ought to have been a party to the proceedings rather than filing his affidavit.

Further, if the same drug was administered to all the family members and after the third dose was administered to the appellant he had suffered the present discomfort complained of, it would also raise a question as to whether it had been administered in the manner and at this spot where it ought to be administered.

“In a circumstance as in the instant case, it is not just the manufacturer and the consumer are involved but the medical professional who ought to have knowledge of the product and before administering had an opportunity to advice the appellant on these aspects had not made any efforts. He cannot claim to become wise in hindsight,” said the court.

The NCDRC, vide order dated 25.04.2012, had dismissed the consumer complaint seeking compensation of over Rs. 90 Lakhs from drug-manufacturer, Glaxo Smithkline Pharmaceuticals. The NCDRC had concluded that the complainant had failed to establish his case, both with respect to the alleged defect in the drug or any negligence amounting to deficiency in service on part of the pharmaceutical company. The Commission was also of the view that not indicating ‘myositis’ as an adverse reaction in the literature accompanying the vaccination or on the ‘vial’ did not amount to deficiency since it was an adverse reaction to the ‘minimal level’.

In the appeal filed against the decision of the NCDRC, the top court observed that there was no documentary evidence placed on record to indicate the very basic issue of purchase of the vaccine and it being administered, except for the affidavit of the family doctor stating that the injection was administered by him to the complainant.

Perusing the affidavit, the court held that there was no material based on which the family doctor had reached the conclusion of the complainant suffering reaction of the Engerix-B vaccine. The court thus found that the affidavit of doctors filed in the case were not of any evidentiary value.

“The said doctors, except vaguely stating about the incident have not authentically provided any details based on their medical expertise or on their research on the subject from medical literature or commentaries about the adverse reaction of the vaccine in question nor have they brought on record any authentic material. In the absence of such medical evidence, the Courts on their own will lack the expertise to come to a conclusion, more particularly in a case of the present nature where the cause itself is required to be unravelled,” said the court.

Thus, the court held that the complainant had failed to discharge the initial burden of substantiating the allegations made in the consumer complaint.

“The affidavit filed by the family doctor and the uncle of the appellant who is also a doctor, except referring to the fact of the vaccine being administered to the appellant and the appellant complaining of the discomfort subsequent thereto does not bring on record the aspect in medical terms or with reference to any medical records to co-relate that the pain suffered by the appellant was in fact ‘myositis’ and it was due to the vaccine being administered,” said the court.

The bench added that the burden was on the complainant to substantiate the allegations, more particularly since the entire family had got the same vaccination administered from the same source and the complainant himself did not undergo any difficulty when the first two doses were administered.

The court further found that the muscle biopsy was not furnished by the complainant despite being asked to do so by the pharmaceutical company, and thus the same should be held adversely against the former.

The court thus upheld the order of the NCDRC and dismissed the appeal.

Case Title: Prakash Bang vs Glaxo Smithkline Pharmaceuticals Ltd. & Anr.

Citation : 2023 LiveLaw (SC) 764

Counsel for the Appellant: Senior Advocate Anita Shenoy, Ms. Aparna Jha, AOR

Counsel for the Respondent: Mr. Ujjwal A. Rana, Adv. Mr. Himanshu Mehta, Adv. M/S. Gagrat and Co, AOR

Consumer Protection Act, 1986: The Supreme Court has upheld the order of the National Consumer Disputes Redressal Commission (NCDRC) where the Commission had held that no case of deficiency of service was made out against drug-manufacturer, Glaxo Smithkline Pharmaceuticals Ltd, in relation to administration of vaccine Engerix-B.

The court found that the complainant had failed to prove the allegations with the minimal required evidence even on a preponderance of probability. The top court further held that non-mentioning of ‘myositis’ as an adverse reaction in the literature accompanying the injection or on the ‘vial’, did not amount to ‘deficiency of service’ on part of the pharmaceutical company, more particularly when the adverse reaction was to the minimal level, i.e., 0.02 in one million.

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