Insufficient Evidence in Vaccine Injury Case

The brief facts leading to the complaint is that the appellant in order to achieve immunity against contracting Hepatitis B, on 10.08.1998 approached his family physician Dr. The appellant took certain analgesics under medical advice and visited an orthopaedic surgeon on 17.08.1998.

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Since his grievance was not redressed but in the process since the appellant learnt that the pain being suffered by the appellant was due to ‘myositis’ which is a condition occurring as an adverse reaction due to the administration of Engerix-B, he again contacted the respondents.

Before the NCDRC, though no documents were placed on record on behalf of the appellant with regard to the purchase of the vaccine or with regard to the nature of the treatment undergone by the appellant relatable to the shoulder pain experienced by the appellant immediately after being vaccinated so as to connect the two incidences and establish that the appellant had suffered ‘myositis’ due to the administration of vaccine, the appellant in addition to his own affidavit had also filed the affidavit of Dr. The respondents, apart from producing the certificate for release of the vaccine and the details thereof had filed the affidavit of Shri Ajay Nadkarni, the Company Secretary as also that of Ms. The opposite party therefore recommended that the complainant undergo muscle biopsy so as to establish the cause of his suffering with myositis. Besides no other person from the city of Pune, who must have taken such injection have reportedly suffered from any adverse reaction as complained of due to the administration of the said drug.” “In any case, the opposite parties have put on record detailed analysis of the various kinds of examination/ tests conducted in the laboratory of the opposite party on the sample drug of the particular lot and found that all the values had passed the requisite standard and the drug of that lot suffered from no defect of any kind which could possibly lead to a reaction of the kind which the complainant had allegedly suffered.”

“That by not mentioning Myositis as one of the adverse reaction, which was too minimal i.e. Though the matter was heard at length, the position as it exists if taken into consideration, the aspect to be determined in the instant case, firstly is as to whether there is sufficient evidence to establish that the appellant in fact had suffered ‘myositis’ and if so whether the cause for same was the vaccination Engerix-B being administered to the appellant.

In a matter of the present nature where the appellant contends that he and his family members had taken the vaccination and his family members had no complaint whatsoever and also insofar as the appellant, since the earlier two doses had not caused any problem or discomfort but the pain was noticed only after final dose, the matter requires to be viewed with circumspection. The learned senior counsel for the appellant in order to contend that the said affidavits would be sufficient for the Court to come to a conclusion with regard to the case put forth by the appellant has relied on the decision of this Court in Malay Kumar Ganguly vs Dr. In the instant case, though in the summary procedure before the NCDRC the cross-examination in the nature as done in the Civil Court would not be followed, it is no doubt true that in a normal circumstance it would be open to file interrogatories relating to the statements made in the affidavit. Neither the affidavit of the doctors who had subsequently treated the appellant with specific reference to the shoulder pain has been filed nor has the said doctor who has filed the affidavit indicated any reference in medical terms or with regard to his medical research on the subject to place it on affidavit that the vaccination was the cause due to which the appellant had suffered ‘myositis’ and had led to the disablement in the nature as stated by the appellant seeking for compensation. Therefore though the affidavit of doctors had been filed in the instant case, they are not of any evidentiary value whatsoever and the legally trained mind who was representing the respondents would well be aware that an affidavit of such nature did not warrant any cross- examination as the affidavit on the face of it had not indicated anything to establish the case of the appellant.

As already noted, 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.

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On this aspect, at the outset we note that the affidavit filed on behalf of the respondents would indicate the detailed procedure that is followed for certification of the drug.

If these aspects of the matter are kept in view, in fact 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 affidavit.

In that view of the matter, the judgment relied on by the learned senior counsel for the appellant in Jacob Punnen and Another vs United India Insurance Company Limited (2022) 3 SCC 655 with reference to para 43 to contend that there was a deficiency on the part of the respondent would not be of any assistance.

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Therefore in the facts on hand, if the matter is looked at from its correct perspective it is seen that 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 on preponderance of probability. Applications if any pending are also disposed of.

Case Title: PRAKASH BANG Vs. GLAXO SMITHKLINE PHARMA. LTD.

Case Number: C.A. No.-006791-006791 / 2013

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