PRAKASH BANGversusGLAXO SMITHKLINE PHARMACEUTICALS LTD. & ANR.

                 [2023] 12 S.C.R. 567 : 2023 INSC 794



                           CASE DETAILS

                           PRAKASH BANG
                                    v.
   GLAXO SMITHKLINE PHARMACEUTICALS LTD. & ANR.
                    (Civil Appeal No. 6791 of 2013)
                         SEPTEMBER 05, 2023
  [A. S. BOPANNA AND PRASHANT KUMAR MISHRA, JJ.]
                             HEADNOTES
      Issue for consideration: Whether there is sufficient evidence to
establish that the complainant suffered ‘myositis’ on administration of the
vaccine Engerix-B; and 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’, could be considered as ‘deficiency of service’.
     Consumer Protection Act, 1986 – Negligence – Deficiency in
service – Complainant alleging that on account of adverse reaction
of the Hepatitis vaccine Engerix-B administered, he suffered myositis
and permanent disability in his shoulder – Natiownal Commission held
that the complainant failed to establish either any defect in the drug
or any negligence amounting to deficiency in service on the part of the
manufacturer of the drug – Interference with:
      Held: Not called for – No case of deficiency in service or negligence
on the part of the manufacturer of the drug made out – On facts, when all
the family members had got administered the same vaccination from the
same source and the complainant himself did not undergo any difficulty
when the first two doses were administered, the onus to discharge the
initial burden was heavy on the complainant to establish his case, which he
failed to do so – Except for the affidavit filed by the doctors known to the
complainant, no other evidence available on record – Affidavit of doctors not
of any evidentiary value – In the absence of medical evidence, the Courts
on their own lack the expertise to come to a conclusion – Furthermore, no
documentary evidence to indicate the purchase of the vaccine and the same
being administered – Medical professional who ought to have knowledge
                                    567
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of the product and before administering had an opportunity to advice the
complainant on these aspects had not made any efforts – He cannot claim
to become wise in hindsight – In any event, the instance of ‘myositis’ being
minimal to the extent of 0.02 in a million, case of negligence on the part of
the manufacturer not made out – Except for the complainant assuming that
he suffered ‘myositis’ and the cause for the same was the Engerix-B vaccine
being administered, the same not established with the minimal required
evidence to conclude even on preponderance of probability. [Paras 9, 12-17]

       LIST OF CITATIONS AND OTHER REFERENCES

      Malay Kumar Ganguly v. Dr. Sukumar Mukherjee & Ors. (2009) 9 SCC
221; Jacob Punnen and Another v. United India Insurance Company Limited
(2022) 3 SCC 655; Chanda Rani Akhouri and Ors. v. M.A. Methusethupathi
and Ors. (2022) SCC Online SC 481 – referred to.
       OTHER CASE DETAILS INCLUDING IMPUGNED
              ORDER AND APPEARANCES

      CIVIL APPELLATE JURISDICTION: Civil Appeal No. 6791 of 2013.
    From the Judgment and Order dated 25.04.2012 of the National
Consumer Disputes Redressal Commission, New Delhi in Original Petition
No.178 of 1999.
      Appearances:
    Mrs. Anitha Shenoy, Sr. Adv., Shantanu M. Adkar, Ms. Ayushma
Awasthi, Ms. Namrata Caleb, Ms. Pariksha, Ms. Aparna Jha, Advs. for the
Appellant.
     M/s. Gagrat and Co., Ujjwal A. Rana, Himanshu Mehta, Advs. for
the Respondents.

       JUDGMENT / ORDER OF THE SUPREME COURT

                               JUDGMENT
      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
         PRAKASH BANG v. GLAXO SMITHKLINE            569
     PHARMACEUTICALS LTD. & ANR. [A. S. BOPANNA, J.]

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 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 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 learnt that the pain being suffered by the appellant was due
to ‘myositis’ which is a condition occurring as an adverse reaction due to
570          SUPREME COURT REPORTS                          [2023] 12 S.C.R.


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 ‘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 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
        PRAKASH BANG v. GLAXO SMITHKLINE            571
    PHARMACEUTICALS LTD. & ANR. [A. S. BOPANNA, J.]

‘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 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
572          SUPREME COURT REPORTS                         [2023] 12 S.C.R.


      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. 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 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
        PRAKASH BANG v. GLAXO SMITHKLINE            573
    PHARMACEUTICALS LTD. & ANR. [A. S. BOPANNA, J.]

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 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 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 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
574          SUPREME COURT REPORTS                          [2023] 12 S.C.R.


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 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 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
        PRAKASH BANG v. GLAXO SMITHKLINE            575
    PHARMACEUTICALS LTD. & ANR. [A. S. BOPANNA, J.]

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 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 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
576          SUPREME COURT REPORTS                          [2023] 12 S.C.R.


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 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 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.
      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
         PRAKASH BANG v. GLAXO SMITHKLINE            577
     PHARMACEUTICALS LTD. & ANR. [A. S. BOPANNA, J.]

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.
     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.


Headnotes prepared by:                                         Appeal dismissed.
Nidhi Jain