2023INSC794 REPORTABLE

IN THE SUPREME COURT OF INDIA

CIVIL APPELLATE JURISDICTION

CIVIL APPEAL NO. 6791 OF 2013

Prakash Bang .… Appellant(s)

Versus

Glaxo Smithkline Pharmaceuticals

Ltd. & Anr. …. Respondent(s)

J U D G M E N T

A.S. Bopanna, J.

1. The appellant is before this Court assailing the order

dated 25.04.2012 passed by the National Consumer

Disputes Redressal Commission, New Delhi (‘NCDRC’ for

short) in Consumer Case No.178 of 1999. Through the said

order the NCDRC has held that the complainant has

miserably failed to establish his case in regard to either any

defect in the drug in question or any negligence amounting

Civil Appeal No.6791 of 2013 Page 1

to deficiency in service on the part of the respondent who is

the manufacturer of the drug. In that view, the complaint

filed by the appellant was dismissed by the NCDRC.

2. 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. Satyajit Pathak for administering the repeat dose of the

vaccine Engerix-B, along with his family members. The

appellant contended that he had purchased four single dose

vaccines which were administered by Dr. Satyajit Pathak,

one each to him, his wife and two sons. The family members

of the appellant had no adverse reaction to the said drug

but insofar as the appellant, after four days of being

vaccinated, the appellant felt severe pain in his left shoulder

at the site of the injection and he suffered pain while

moving his shoulder. It was noticed that the skin at the

place where he was injected was found shiny with a bit of

erythema with local tenderness. The appellant took certain

analgesics under medical advice and visited an orthopaedic

Civil Appeal No.6791 of 2013 Page 2

surgeon on 17.08.1998. The orthopaedic suggested certain

radiological tests like X-ray and C.T. Scan of the left

shoulder but no orthopaedic abnormality was detected.

3.The appellant thereafter contacted a general physician

named Dr. Madan Phadnis and a general surgeon Dr.

Makarand Paranjpe who examined the appellant had

referred him to a neuro physician. After taking treatment

from 13.09.1998 he was admitted in Ruby Hall Clinic where

he was examined by neuro physician and the nerve

conduction test was carried out and a dose of steroids was

administered. The appellant contended that he developed

sudden permanent disability in his shoulder which

according to him was caused due to adverse reaction of the

vaccine Engerix-B manufactured by the respondents and

administered on 10.08.1998. The appellant was working as

a Chief Executive of M/s Quicksel Communications, which

effected his performance and as such he had taken up the

issue with the respondent company. Since his grievance

was not redressed but in the process since the appellant

Civil Appeal No.6791 of 2013 Page 3

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. Since the response of the

respondents was not satisfactory and according to the

appellant since the same amounted to deficiency due to

negligence which had also caused suffering to the appellant,

he filed the above noted complaint before the NCDRC

claiming compensation of Rs,90,20,557/- (Rupees Ninety

Lakhs Twenty Thousand Five Hundred and Fifty Seven

Only).

4.The respondents appeared before the NCDRC and filed

their version disputing the claim as put forth by the

appellant. The very allegation of the purchase of the said

drug or its administration was denied for want of

knowledge and also since no proof in that regard had been

produced along with the complaint. However, insofar as the

very nature of the drug and about its quality and purity

details, they were referred to. It was explained with regard to

Civil Appeal No.6791 of 2013 Page 4

‘myositis’, since it can occur for various reasons and in

different circumstances. Hence it was contended that the

appellant had failed to establish that he suffered with

‘myositis’ on account of any adverse reaction due to the

administration of Engerix-B.

5.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. Satyajit

Pathak who is said to have administered the vaccine as also

the affidavit of Dr. V.L. Chandak who is the uncle of the

appellant. The appellant is said to have consulted Dr.

Satyajit Pathak and Dr. V.L. Chandak after suffering the

discomfort due to the vaccination. The said affidavits were

Civil Appeal No.6791 of 2013 Page 5

filed in lieu of evidence. 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. Catherine

Ghislain, the Vice-President, Associate General Counsel of

the respondent referring to details with regard to the

procedure followed for manufacture and as also the

certification of the drug.

6.In the above background, the NCDRC has considered

the rival contentions in detail and on the aspect of the drug

in question causing ‘myositis’ had taken into consideration

that the same is an adverse reaction to the minimal level

and not indicating the same as an adverse reaction in the

literature accompanying the vaccination or on the ‘vial’ does

not amount to deficiency. To arrive at such conclusion the

relevant observations in the order of the NCDRC are as

hereunder:-

“On the basis of their worldwide safety database, the

opposite parties could search out such nine cases

involving four female and four male patients of the age

Civil Appeal No.6791 of 2013 Page 6

range of 23-51 years. Based on the number of doses

distributed worldwide, the reported frequency of this

adverse reaction could be calculated to a minimal

incidence i.e. 0.02 per million doses. At the same time

they explained that the relationship of such cases to

the vaccine was difficult to establish. The opposite

party therefore recommended that the complainant

undergo muscle biopsy so as to establish the cause of

his suffering with myositis. In this case the muscle

biopsy was never sent to the opposite party. In any

case, it is brought on record that there could be many

other causes leading to the myositis. That apart there

are several attenuating circumstances which would

rather indicate that the alleged adverse reaction

suffered by the complainant was not on account of the.

administration of the above named drug. The

circumstances are that before taking third repeat dose

on 10.8.1998, the complainant and his family

members had already taken two doses but neither the

complainant nor his family members suffered with any

such symptoms or reaction on those occasions.

According to the complainant's own showing on

10.8.98 the other two family members of the

complainant i.e. his wife and sons were also given the

similar single dose besides to the complainant but

neither the wife nor the sons of the complainant

suffered any such adverse reaction. The drug used in

all the cases was from the same batch. Had the drug of

that particular batch had any such defect or deficiency,

the reaction should have been common ·for other

members also. 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.”

Civil Appeal No.6791 of 2013 Page 7

“That by not mentioning Myositis as one of the adverse

reaction, which was too minimal i.e. 0.02 in one

million, it was not necessary for the opposite parties to

mention the same under the heading "Adverse

Reaction". ln any case, despite such minimal

incidences it was not established with certainty that

myositis could be a direct cause arising out of the

adverse reaction of the said· drug. We find force in this

contention because the opposite party could not have

mentioned myositis as one of the expected adverse

reaction unless it was so established by Laboratory or

other tests.”

7.In that background we have heard Ms. Anita Shenoy,

learned senior counsel for the appellant, Shri Ujjwal A.

Rana, learned counsel for the respondents and perused the

appeal papers including the records received from the

NCDRC.

8.In that circumstance, what is necessary to be taken

note and consider herein is as to whether the conclusion as

recorded by the NCDRC and noted above can said to be

erroneous or perverse so as to call for interference. 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

Civil Appeal No.6791 of 2013 Page 8

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.

The second aspect is as to whether even if ‘myositis’ being a

minimal cause is accepted, the non-mentioning of the same

as an ‘adverse reaction’ in the literature or ‘vial’, if could be

considered as ‘deficiency of service’, more particularly in the

instant facts and circumstances of the case.

9.As noted, there is no documentary evidence placed on

record to indicate the very basic issue of the purchase of the

vaccine and the same being administered. Be that as it may,

the fact remains that the family doctor of the appellant

namely Dr. Satyajit Pathak has filed his affidavit stating that

the Engerix B injection was administered by him to the

appellant on 10.08.1998 at the deltoid muscle on the left

arm. The said doctor has stated that the vaccine was a

single dose adult vaccine bought from a chemist in Pune.

There is no details indicated as to whether he had advised

and on his prescription the said vaccine was purchased. In

Civil Appeal No.6791 of 2013 Page 9

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. Hence the onus to discharge

the initial burden was heavy on the appellant to establish

his case in a fact of the present nature. Except for the

affidavit filed by the doctors known to the appellant, there is

no other evidence available on record. The second witness

on behalf of the appellant is his uncle who is stated to have

been consulted by the appellant. The statements as

contained in the said affidavit are more to refer with regard

to the advice that they have tendered to the appellant and

also to state with regard to similar complaint having come to

their knowledge.

10. The learned senior counsel for the appellant in order

to contend that the said affidavits would be sufficient for the

Civil Appeal No.6791 of 2013 Page 10

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. Sukumar

Mukherjee & Ors. (2009) 9 SCC 221 with reference to para

45 wherein it is observed that the opinions of the experts

rendered on the basis of their expertise, which were

notarised would be reliable more so when the respondents

did not question the correctness thereof either before the

Court or the Commission and when the respondents did not

examine any expert to show that the opinions are not

correct.

11.In our opinion, the said observation in the judgment

cannot read as a provision in the statute but will be to

assess the evidentiary value keeping in view the overall

nature of the case and the evidence that is brought on

record and if the affidavit is in support of such material. 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

Civil Appeal No.6791 of 2013 Page 11

that in a normal circumstance it would be open to file

interrogatories relating to the statements made in the

affidavit. In the instant case it is true that no such effort

has been put forth by the respondents but in our view it is

not detrimental.

12. As against what was considered in the case which has

been cited by the learned senior counsel for the appellant

wherein it is clearly indicated that the medical records had

been referred to in the affidavit filed by the doctor, a close

perusal of the affidavit filed by Dr. Satyajit Pathak would

indicate that he has stated only about administering the

vaccine and the fact of the shoulder pain being reported to

him subsequently. The advice he had given in that regard

and the medication prescribed is also stated. He thereafter

states the names of the doctors to whom he had referred the

appellant for further treatment. 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

Civil Appeal No.6791 of 2013 Page 12

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.

The only averment in this regard is contained in para 24 of

the affidavit wherein he states that he being the family

doctor of the appellant is of the opinion that it is nothing

but the reaction of the Engerix-B vaccine because of which

the complainant has suffered a lot. As already noted there is

absolutely no material based on which such conclusion has

been reached by the said doctor except to opine in that

manner. In such circumstance, the non cross-examination

or tendering interrogatories was wholly unnecessary in

respect of the affidavit filed by him.

13. Insofar as the affidavit of doctor V.L. Chandak,

admittedly he is the uncle of the appellant with whom the

appellant has made certain correspondence about the pain

suffered in his left arm. Though in the affidavit he refers to

Civil Appeal No.6791 of 2013 Page 13

one Dr. Sham Karwa, an Eye Specialist known to him

having suffered a similar problem because of reaction on

administration of vaccine Engerix-B and that he had

suffered for about 2 to 3 months, the same can only be

noted as hearsay since neither the affidavit of said Dr. Sham

Karwa has been filed nor is there any material to indicate

that the said doctor had taken vaccine and had suffered

similarly. The other instance referred in the affidavit is also

to the same affect. 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.

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

Civil Appeal No.6791 of 2013 Page 14

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.

14. If that be so, in our opinion, we find that the initial

burden to be discharged by the appellant has not been

discharged to substantiate the allegation which was made in

the complaint. 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. The burden was on the

appellant more particularly in a circumstance when all the

Civil Appeal No.6791 of 2013 Page 15

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 by the

respondents should be held adversely against the appellant.

15. The next aspect for consideration would be as to

whether the non-mentioning of ‘myositis’ being suffered as

an adverse reaction in the literature accompanying the

injection or on the ‘vial’ amounts to ‘deficiency of service’,

more particularly when the adverse reaction was minimal

only to the extent of 0.02 in one million. 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. It is only after such

certification the drug is available in the market. Nothing has

been placed on record to indicate that this is a drug which

was available ‘of the shelf’, without prescription. In the

instant facts, the very affidavit filed on behalf of the

Civil Appeal No.6791 of 2013 Page 16

complainant by Dr. Satyajit Pathak, the family doctor refers

to the purchase of the vaccine and the same being

administered by him. The said family doctor also owed a

duty to his patient and if he has prescribed the said drug it

was incumbent on him to know more details about the

vaccination before prescribing or administering the same.

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. 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.

16. In that view of the matter, the judgment relied on by

the learned senior counsel for the appellant in Jacob

Civil Appeal No.6791 of 2013 Page 17

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. Further,

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. 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. Hence the decision relied on by the learned

senior counsel for the appellant in the case of Chanda

Rani Akhouri and Ors. vs. M.A. Methusethupathi and

Ors. (2022) SCC Online SC 481 with specific para 24 is

also not of any assistance.

Civil Appeal No.6791 of 2013 Page 18

17. 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 even on

preponderance of probability. That apart, as noticed, even

muscle biopsy which was required by the respondents was

not furnished so as to enable the respondents to take an

ultimate decision in the matter. As such the appellant

cannot be heard to complain that the respondents have not

attempted to redress his grievance. Therefore, if all these

aspects are taken into consideration we are of the opinion

that the NCDRC has not committed any error so as to call

for interference with the impugned order.

Civil Appeal No.6791 of 2013 Page 19

18. Accordingly, the appeal being devoid of merit stands

dismissed with no order as to costs.

19. Applications if any pending are also disposed of.

………………...…………………….J.

(A.S. BOPANNA)

..

………………….…………………J.

(PRASHANT KUMAR MISHRA)

New Delhi,

September 05, 2023

Civil Appeal No.6791 of 2013 Page 20