Family doctor should have advised about adverse reaction of vaccine: SC rejects claim against pharma company

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The court said in the case, except for the affidavit filed by the doctors known to the appellant, there is no other evidence available on record. The family doctor, who administered the vaccine, should have advised about adverse reaction, instead of claiming to have become wise in hindsight, it added

The Supreme Court has rejected a plea by a man against the National Consumer Disputes Redressal Commission's order which dismissed his allegations of deficiency of service on part of a drug company for shoulder pain and 'myositis’ suffered on account of adverse reaction due to the administration of vaccine 'Engerix-B'.

A bench of Justices A S Bopanna and Prashant Kumar Mishra found no ground for interference with the NCDRC's order which, it said, has not committed any error in rejecting claim of Prakash Bang, then working as CEO of M/s Quicksel Communications for compensation of over Rs 90 lakh.

"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 said.

It also pointed out even muscle biopsy which was required by the drug maker was not furnished so as to enable them to take an ultimate decision in the matter, so the appellant cannot be heard to complain that they have not attempted to redress his grievance. 

The court further noted there is no documentary evidence placed on record to indicate the very basic issue of the purchase and administering of the vaccine.

It also said non-mentioning of ‘myositis’ as an adverse reaction in the literature accompanying the injection or on the ‘vial’ could not be termed as ‘deficiency of service’, more particularly when the adverse reaction was minimal only to the extent of 0.02 in one million.

The appellant contended that he had developed sudden permanent disability in his shoulder due to adverse reaction of the vaccine Engerix-B, manufactured by Glaxo Smithkline Pharmaceutical, which was administered on August 10, 1998 to protect him from Hepatitis B.

He claimed that he learnt that the pain being suffered by him was due to ‘myositis’ which is a condition occurring as an adverse reaction due to the administration of Engerix-B.

The court, however, held the matter of such nature is required to be viewed with circumspection. 

"The onus to discharge the initial burden was heavy on the appellant to establish his case. Except for the affidavit filed by the doctors known to the appellant, there is no other evidence available on record. The second witness (doctor) on behalf of the appellant is his uncle who is stated to have been consulted by the appellant," the bench said.

Therefore, though the affidavit of doctors had been filed in the instant case, they are not of any evidentiary value whatsoever, the bench said.

"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," the bench said.

The court said the burden was on the appellant more particularly in a circumstance when all the family members had got administered the same vaccination from the same source and the appellant himself did not undergo any difficulty when the first two doses were administered. In such circumstance the muscle biopsy not being furnished despite being asked to do so should be held adversely against the appellant, it added.

The court further said in facts of the case, the allegations as made by the appellant would also make the said family doctor responsible and ideally he ought to have been a party respondent to the proceedings rather than filing his

"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," the bench said. 

"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 bench added. 

Case Title: Prakash Bang Vs. Glaxoline Smithline Labs & Ors


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