Full Judgment Text
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
Signature Not Verified
Digitally signed by
Rajni Mukhi
Date: 2023.09.06
12:49:36 IST
Reason:
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
(2009) 9 SCC 221 with reference to para
Mukherjee & Ors.
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
(2022) 3 SCC 655 with reference to
Company Limited
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