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[2014] ZAWCHC 157
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Venter v Roche Products (Pty) Ltd (A11/2014) [2014] ZAWCHC 157 (22 October 2014)
THE
REPUBLIC OF SOUTH AFRICA
IN
THE HIGH COURT OF SOUTH AFRICA
(WESTERN
CAPE DIVISION, CAPE TOWN)
Appeal
No: A11/2014
In
the matter between:
PETRUS
ALBERTUS
VENTER
.............................................................................................
Appellant
and
ROCHE
PRODUCTS (PTY)
LTD
.......................................................................................
Respondent
Coram
:
BOZALEK, DLODLO et SCHIPPERS JJ
Heard:
1 & 4 AUGUST 2014
Delivered:
22 OCTOBER 2014
JUDGMENT
BOZALEK
J:
[1]
The appellant in this matter was a
voluntary participant/patient in an international medical trial
partly conducted in South Africa.
He sued the respondent (as first
defendant) and Dr L Gouws & Partners Incorporated, an oncology
practice, (as second defendant)
for damages flowing from the
perforation of his bowel following the administration to him of
medication forming part of the trial.
[2]
The merits and quantum of the claim were
separated and the trial on the merits was conducted before Fourie J
who ultimately dismissed
the appellant’s claim with costs.
Leave to appeal was refused but on petition the Supreme Court of
Appeal granted the appellant
leave to appeal to the Full Court of the
Western Cape High Court but only on the issue of whether or not a
tacit agreement was
established between himself and the respondent.
This was the main basis upon which the appellant initially sued the
respondent,
his alternative claims being based on a
stipulatio
alteri
and, in the further alternative,
a delictual claim. Similar claims were advanced against the second
defendant.
[3]
In his final amended particulars of claim
the appellant formulated his claim based on a tacit agreement as
follows:
‘
(12)
Eiser beweer dat, in die proses van die verkryging van Eiser se
toestemming soos voormeld, Eerste Verweerder uitdruklik,
alternatiewelik
stilswyend, teenoor Eiser onderneem het om te voldoen
aan die bepalings en voorskrifte van beide die “SA Guidelines”
en die “ABPI Guidelines” vir die hou van mediese en
kliniese proewe met betrekking tot die bepaling van vergoeding
in die
geval van proefverwante beserings, soos voormeld. In die proses het
Eerste Verweerder onderneem en kontraktueel daarvoor
ingestaan
om/dat:
12.1
Op te tree ooreenkomstig die kliniese en etiese vereistes vir die hou
van sodanige proewe in Suid-Afrika, welke onder andere
vereis dat
vergoeding, in die geval van proefverwante beserings deur pasiënte
in Suid-Afrika, nie deur sodanige pasiënte
in Switserland van
die Switserse “sponsor” van die proewe so verhaal sou
moes word nie, maar in Suid-Afrika deur die
Eerste Verweerder as
aansoeker vir en “monitor” van die proef, betaal sou
word;
12.2
Die vergoeding gelyk sou wees aan die skadevergoeding wat normaalweg
deur Suid-Afrikaanse en/of Britse howe (dit is dieselfde)
toegeken
sou word in die geval van die opdoen van beserings waar
regsaanspreeklikheid daarvoor aanvaar word;
12.3
In elk geval, om self die betaling van vergoeding plaaslik (in
Suid-Afrika) te maak en te dan van Le Roche AG te verhaal.’
[4]
The respondent denied the existence of any
tacit contract and pleaded that the appellant had furnished his
informed consent to participation
in the trial in terms of a patient
information leaflet and informed consent (PIL-ICON), which he had
signed. The PIL-ICON referred
inter alia
to the payment of compensation to a volunteer/patient in the event of
a trial-related injury. Given the central importance of that
portion
of the PIL-ICON to the issues in dispute I quote the Afrikaans
version of the relevant clause in full. It reads as follows:
‘
Vergoeding
ingeval van ‘n navorsingsverwante besering
As
u ‘n problem ontwikkel wat mediese aandag verg, en wat nie
regstreeks te wyte is aan die studie – spesifieke behandeling
of prosedures is nie, sal u of u Mediese Hulpvonds gefaktureer word,
soos wat normaalweg sou gebeur;
F
Hoffman – Le Roche AG sal betaal vir die kostes van mediese
behandeling vir enige besering wat regstreeks te wyte is aan
behandeling met die studie- medikasies waar die streng volgens die
studieprotokol gebruik is. Die vergoeding sal geskied ooreenkomstig
die “Vergoedingsrigslyne vir Kliniese Proewe” wat in 1991
deur die Vereniging van die Britse Farmaseutiese Bedryf (ABPI)
gepubliseer is.
U
kan ‘n afskrif van hierdie ABPI riglyne by u dokter bekom. Geen
ander vergoeding word aangebied nie.’
[5]
The English version of the relevant clause
is to all intents the same, the only possible point of contention
being that the phrase
‘
die
vergoeding sal geskied’
is
rendered as ‘
the compensation
available …’
in the
English version.
[6]
It was common cause that the appellant had
signed the consent at the conclusion of a consultation with Dr S van
der Merwe, a medical
practitioner in the employ of the second
defendant (GVI Oncology), after he had explained and taken the
appellant through the PIL-ICON
point by point.
[7]
It was the appellant’s case that Dr
van der Merwe had represented the respondent in dealing with him on
15 June 2005.
[8]
The respondent denied that Dr van der Merwe
had represented it in dealing with the appellant on 15 June 2005 and
contended, furthermore,
that the compensation undertaking was
expressly given by F Hoffman-Le Roche AG (‘FHLR’), a
pharmaceutical company situated
in Basel, Switzerland, which company
was not cited as a defendant.
[9]
It was common cause that the respondent was
a company with limited liability registered and carrying on business
in South Africa.
[10]
The respondent pleaded further that the
compensation undertaking contained in the PIL-ICON was expressly
given by FHLR and not by
it; further that the compensation provisions
in neither the ABPI nor the SAGCP guidelines imposed a legally
enforceable obligation
on the sponsor of a clinical trial in relation
to the payment of compensation for a trial-related injury.
FACTUAL
BACKGROUND
[11]
The following background facts do not
appear to be disputed. The multinational medical trial was initiated
by FHLR and related to
cancer medication which it had registered in
various countries for the treatment of colon, breast and lung cancer.
That medication
was to be evaluated for efficacy and safety in
patients whose cancer had not yet spread to other parts of the body.
[12]
The trial involved some 3 450 patient
volunteers and was conducted in 30 countries, including the host
country Switzerland.
It involved approximately 350 sites, including
five South African sites. Forty-five of the patient volunteers were
to come from
South Africa.
[13]
The protocol for the trial, developed by
FHLR in Switzerland, was a lengthy and complex document prepared for
presentation to the
local regulatory bodies of the different
countries seeking authorisation to conduct a trial in such countries.
[14]
FHLR concluded a written agreement with the
respondent in terms of which the latter undertook to conduct the
medical and clinical
research trial in South Africa and in so doing
to ‘
act as independent contract
clinical development services provider’
.
In terms of this agreement the respondent undertook responsibility
inter alia for the ‘
initiation and
implementation of clinical trials in the Territory according to the
Standard Operating Procedures of the Roche Group’
.
[15]
It was common cause that FHLR is a company
which engages in research development and the marketing of medicines
worldwide. The relationship
between it and the respondent was never
entirely clarified in evidence but it seems that, although an
independent legal entity,
the respondent formed part of the overall
Roche Group.
[16]
Pursuant to the aforesaid agreement the
respondent, in its capacity as the local representative of FHLR,
applied to the Medicines
Control Council of South Africa (‘the
MCC’) for permission to conduct the trial in South Africa. At
the same time parallel
written applications were made to Pharma
Ethics and the Ethics Committee of the Witwatersrand University for
ethical approval of
the trial in relation to each of the sites. Key
documents in these applications included the FHLR protocol and the
draft PIL-ICON.
[17]
The respondent also annexed certificate to
its application to the MCC indicating that insurance had been
obtained by FHLR from Zurich
Insurance providing cover for ‘
all
subsidiaries and associated companies of the Roche Group and/or all
hospitals and physicians contracted to perform clinical
trials on
behalf of all subsidiaries and associated companies of the Roche
Group’
for ‘
comprehensive
general and product liability including clinical trials according to
the local law in the concerned country’
.
[18]
In due course approval for the trial was
granted by the MCC, Pharma Ethics and Witwatersrand University none
of which made any material
alteration to the draft PIL-ICON. The
authorisation by the MCC provided that the clinical trial was to be
conducted in accordance
with the protocol submitted to it. That
protocol included as a specific attachment the 17 page detailed
PIL-ICON which inter alia
set out the nature and purpose of the
study, its aim, the risks and side effects, the benefits, alternative
treatment, the confidentiality
of records and the compensation
payable. The standard consent form signed by the appellant stated,
inter alia:
‘
I
have read this information and understood the purposes of the study
as well as the possible benefits and risks of participating.
I have
had a chance to ask questions and all of my questions have been
answered in a way I understand. … By signing this
form I give
my free and informed consent to take part in this study. I understand
that there may be risks and discomfort associated
with the study
procedures.’
[19]
The respondent also concluded an ‘
agreement
for clinical study’
with the
second defendant to conduct the trial at a site at the Panaroma
Hospital, Plattekloof, Western Cape. For the sake of clarity
I shall
refer to the second defendant, the employer of Dr Van der Merwe, as
‘
GVI Oncology’
.
In terms of that agreement GVI Oncology undertook to use the
PIL-ICON to obtain informed consent from each patient prior
to the
initiation of any study.
[20]
Under the heading
‘
Insurance
and Compensation for Medicine Induced Injury’
,
the respondent undertook vis-à-vis GVI Oncology to ‘
assume
liability for injuries that occurred in study subjects or patients
whenever a cause or relationship can be established between
the event
and the clinical study procedure or the Roche compound, …’
in stipulated circumstances, principally that the adverse event
resulted from a Roche study substance administered according to
the
approved Roche study protocol. GVI Oncology undertook to report in
full any ‘
adverse event’
to
the respondent according to the protocol as well as notifying the MCC
and the Ethics committee.
[21]
The appellant had previously undergone
surgery for colon cancer and was considered to be a suitable
candidate for inclusion in the
trial. He was first informed of the
trial and that he was a suitable participant by Dr Hannelie du Toit,
an oncology specialist,
in a consultation on 10 June 2005. He was
given a copy of the PIL-ICON for perusal in his own time and, after
discussion with his
wife over the weekend, called Dr du Toit on 13
June 2005 to confirm his decision to take part in the trial.
[22]
Two days later on 15 June 2005 the
appellant had the consultation described earlier with Dr van der
Merwe of GVI Oncology who took
him through the PIL-ICON point by
point and secured his signature to the consent form.
[23]
The appellant was randomly allocated to one
of the three arms of the trial each of which involved a slightly
different course of
medication but still complying with optimum
treatment. He received one round of medicinal therapy in early July
but nine days later
experienced acute abdominal pain which led to him
being hospitalised at Panorama Hospital. He underwent a laparotomy
following
which a bowel perforation of some 3 – 4mm was
repaired leaving him with a temporary stoma and a Hartman’s
rectal stump.
Additionally, in September 2005, the appellant
underwent a cholecystectomy in Worcester. The appellant has to date,
for reasons
which are not material to the appeal, chosen not to have
the colostomy reversed notwithstanding FHLR’s acceptance of
liability
to compensate him for the medical and related costs
attendant upon such a procedure.
[24]
Dr van der Merwe reported these
developments to the respondent as a trial-related serious adverse
event (‘SAE’). The
FHLR Basel-based clinical science
leader for the trial initially doubted that the bowel perforation was
trial-related. Dr van der
Merwe was unhappy with this conclusion,
however, and made further submissions furnishing, it would appear,
the correct time lines.
Thereafter the respondent’s local
representative was requested by the science leader to convey to Dr
van der Merwe
‘
full acceptance of
the relationship of this event to treatment’.
Pursuant to this indication Dr van der Merwe wrote to the appellant
on 11 August 2005 stating inter alia, under the heading
‘
Accountability
for your hospital expenses’
,
that ‘
as far as accountability is
concerned Roche has agreed to be responsible for treatment of any
injury arising directly from the study
medication or procedures
arising from the protocol’
and
adding ‘
this obviously is relevant
to your recent admission for the perforation of your bowel’
.
Some months later FLHR’s legal
department formally approved payment for the appellant’s
medical costs arising out of
the SAE and he was invited to submit
invoices relating to his medical and hospital services in this regard
for payment by them.
[25]
This process did not appear to run
smoothly, however, with the result that the appellant found himself
out of pocket and having
to pay certain service providers directly
himself. Ultimately he consulted attorneys and a dispute arose as to
whether the appellant
was entitled to claim full compensation, i.e.
other than direct medical costs, for pain and suffering, loss of
income and general
damages.
THE
PLAINTIFF’S CASE, AS PLEADED
[26]
In para’s [4-8] of his particulars of
claim the appellant sets out the background facts against which the
tacit contract on
which he seeks to rely is to be inferred. These
include the agreement between the respondent and FHLR entitled
‘
Pharma Clinical Development
Agreement’,
the respondent’s
application for regulatory approval to the MCC, including
undertakings given by the respondent to the MCC
therein, notably an
undertaking that the protocol complied with the South African
‘
Guidelines
for Good Clinical Practice’
(‘the SAGCP’). He further referred to various aspects of
the SAGCP including those requiring that there should be provision
for compensation and/or treatment in the event of a trial-related
injury. The appellant pleaded that the respondent was to be regarded
as the ‘
sponsor’
of the trial. Further, the appellant pleaded that the respondent used
the services of GVI Oncology to carry out the trial in terms
of the
written agreement between the respondent and GVI Oncology.
[27]
The appellant pleaded that Dr van der Merwe
explained the terms of the PIL-ICON to him including its provisions
relating to compensation
but he could no longer remember what, if
anything, was said about the precise identity of the party which
would be responsible
for payment of such compensation. The import of
such explanation was, however, that compensation would come from a
South African
entity, namely, the respondent, and would be in
accordance with the relevant ‘
guidelines’
.
[28]
On the strength inter alia of these
documents and allegations, the appellant alleged that in the process
of giving his consent to
participation in the trial the respondent
had given him an express, alternatively a tacit, undertaking, that it
would comply with
the provisions of the SAGCP and the ABPI guidelines
with regard to the payment of compensation for trial-related injuries
and,
in so doing, that the respondent had undertaken to comply with
the clinical and ethical requirements for the holding of trials in
South Africa.
[29]
The appellant averred further that three
components of this contractual undertaking were: such compensation
would not have to be
recovered by patients in Switzerland from
the Swiss sponsor but would be paid in South Africa by the first
respondent; secondly,
such compensation would be equivalent to that
normally awarded by South African and/or British courts in such cases
where liability
is accepted and; thirdly, in any event that the
respondent would pay the compensation locally and thereafter recover
same from
FHLR.
[30]
In response to these allegations the
respondent specifically denied that it was the sponsor of the trial
or that it gave any undertakings
to the appellant that either the
SAGCP or the APBI guidelines imposed legal obligations on the sponsor
of a clinical trial. Its
case was further that the appellant was
warned that one of the most serious common adverse effects of the
trial medication was
a perforation of the bowel (up to one in ten
patients) and that he accepted this risk when he signed the PIL-ICON
and consented
to being included in the trial. It denied that the
appellant had any valid claim for compensation save in accordance
with the clause
in the PIL-ICON quoted in full earlier and then
ultimately from FHLR and not the respondent. The respondent denied
that either
it or FHLR was liable for and of the appellant’s
damages other than the direct medical costs arising out of the SAE.
THE
COURT A QUO’S FINDINGS
[31]
After reviewing all the relevant objective
facts and circumstances and the conduct of the parties Fourie J found
that they did not
justify the inference that the appellant and the
respondent intended to, and did, conclude the tacit contract
contended for by
the appellant. He noted that FHLR was the initiator
and world-wide sponsor of the clinical trial, the nature of the
application
which had to be made for authorisation and approval of
the trial in South Africa, including the FHLR protocol and the
PIL-ICON,
the MCC’s requirement that a local entity should be
appointed as the local contact for the trial, the terms of the
agreement
concluded between FHLR and the respondent and that the
aforementioned applications to the regulatory and ethical authorities
indicated
that FHLR was the sponsor and the respondent the applicant.
[32]
Fourie J noted further the terms of the
insurance, which was obtained by FHLR as policy holder, and also had
regard to the terms
of the written agreement between the appellant
and GVI oncology. He also noted that the appellant had been in
possession of the
PIL-ICON for some five days and thereafter had it
explained to him point by point by Dr van der Merwe following which
he signed
it. Focusing on the PIL-ICON, Fourie J noted its repeated
references to FHLR and its terms relating to compensation and he took
into account the financial aspects of the arrangements between FHLR
and the respondent, which involved the latter having to provide
FHLR
with a budget for approval and that it recovered its expenses from
FHLR on a monthly basis. He noted that the trial was accordingly
not
financed by the respondent. Fourie J observed further that where
medical treatment was required following an SAE an estimate
thereof
had to be provided to FHLR which thereafter decided whether the
respondent could incur such medical expenses and thereafter
be
reimbursed by it (FHLR). He noted further that all data collected
during the trial was sent to the central archives of FHLR
and that
the respondent had no right to suspend or terminate the trial.
Finally, Fourie J noted that in terms of the SAGCP guidelines
it was
the sponsor’s responsibility to pay compensation to patients
who suffered bodily injuries and that there had been
no delegation of
this obligation by FHLR to the respondent.
[33]
Fourie J found that FHLR was the initiator
and sponsor of the clinical trial and that the respondent had been
the South African
contact for the trial; that the SAGCP guidelines
placed the obligation on the sponsor to compensate
patients/volunteers, an obligation
which FHLR had not delegated. He
found that the PIL-ICON document made it abundantly clear that FHLR
was the initiator and sponsor
of the trial and the entity which
undertook to pay compensation. He found too that as a result of his
exposure to the PIL-ICON
document, a reasonable person in the
position of the appellant would have been aware of its content and in
particular the compensation
provisions. The learned judge found that
there was no evidence that Dr van der Merwe had the actual authority
(expressed or implied)
to conclude, on behalf of the respondent, the
tacit contract relied on by the appellant. He found that there was no
objective evidence
to indicate that the appellant intended to
contract with the respondent (whose name did not even appear in the
PIL-ICON). He found
that the agreement concluded between the
respondent and GVI Oncology in no way supported the inference
contended for by the appellant,
namely, that GVI’s
representative, Van der Merwe who concluded the agreement and dealt
with the appellant, had the authority
to furnish a compensation
undertaking on behalf of the respondent.
[34]
Finally, the trial judge concluded that the
objective facts and circumstances did not, on a balance of
probabilities, justify the
inference that the appellant and the
respondent had concluded a tacit contract as alleged by the
appellant, or at all.
THE
LAW RELATING TO TACIT CONTRACTS
[35]
It
is worth emphasising the fundamental requirement of consensus in any
contract including tacit agreements. The principle is illustrated
by
the following passage from
Nedcor
Bank Ltd v Withinshaw Properties (Pty) Ltd
[1]
where the Court stated the following regarding the requirements
for a tacit contract:
‘
The
offer and acceptance, indicating unqualified consensus ad idem on all
essential aspects of the agreement, must clearly and unequivocally
be
inferred from the conduct of the parties’.
[36]
In
McDonald
v Young
[2]
the
Court stated:
‘
It
is trite that a tacit contract is established by conduct. In order to
establish a tacit contract, the conduct of the parties
must be such
that it justifies an inference that there was consensus between them.
There must be evidence of conduct which justifies
an inference that
the parties intended to, and did, contract on the terms alleged. It
is clear from the appellant's evidence that
there was no consensus
between the parties.’
[37]
The Court in
McDonald
rejected the appellant’s case that there had been a tacit
agreement between him and the respondent in the form of a joint
venture agreement inter alia on the basis that the appellant’s
reliance on a tacit contract was inconsistent with his evidence.
‘
The
appellant believed and gave evidence to the effect that he and the
respondent had concluded an express agreement in respect
of the
property, the aim of which was to ensure that he was financially
independent. Implicit in this is the intention that he
would not have
to rely on the respondent, or any other person, for financial
support. In the circumstances, the appellant
could not have
formed the intention to contract tacitly with the respondent. Having
regard to his evidence that the purpose of
the joint venture
agreement was to render him financially independent, the appellant
could not at the same time have contemplated
that the respondent
would continue to support him for the rest of his life.
[At
10 E-F]
…
The
appellant's stated belief, that there was an express contract
between him and the respondent in respect of the property,
precludes
this court from drawing an inference to the effect that the parties
had entered into a tacit agreement, the terms of
which were
inconsistent with the express agreement to which he testified.’
[At 11A]
[38]
In
determining whether a tacit agreement has been concluded the conduct
of both parties and the circumstances of the case generally
are
considered, the ultimate question being whether, to all outward
appearances, there was an agreement
[3]
.
One test for deducing the existence of a tacit agreement, the
‘
traditional
statement of principle’,
was stated as follows by Corbett JA
[4]
:
‘
In
order to establish a tacit contract it is necessary to show, by a
preponderance of probabilities, unequivocal conduct which
is
capable of no other reasonable interpretation than that the parties
intended to, and did in fact, contract on the terms alleged.
It must
be proved that there was in fact consensus ad idem.’
[39]
Judicial
debate has ensued as to whether the aforementioned case, with its
requirement of ‘
unequivocal
conduct … capable of no other reasonable interpretation’
might
not set too high a standard of proof and rather that a tacit contract
should be found to have been established if ‘
the
most plausible, probable conclusion from all the relevant proved
facts and circumstances is that a contract came into existence’
[5]
.
[40]
The
element of consensus was underlined in the recent Full Bench decision
of this division in
Woolworths
(Pty) Ltd v P Christodoulou and Sons Textiles and Another
[6]
where Rogers AJ, on behalf of the court, stated as follows at (para
57):
‘
What
is apparent, in my view, is that the courts have always appreciated
the special difficulty which arises when a person asserts
the
existence of a tacit contract. Where a contract is said to have come
into existence through proven express exchanges (whether
oral or
written), it is usually not difficult to decide whether in law the
exchanges evidence an unequivocal offer and acceptance
and thus the
existence of a contract. Where the contract is said to come into
existence tacitly, it is generally more difficult
to draw that
conclusion. One needs to guard against the finding that, because it
would have been reasonable and fair for the parties
to have reached
the alleged agreement if the matter had been specifically discussed,
they therefore were in fact tacitly in agreement.
The question is not
even whether they would probably have reached agreement if the matter
had been raised but whether they were
in fact in agreement although
they did not express it.’
THE
EVIDENCE OF THE APPELANT AND DR VAN DER MERWE
[41]
Against this background it is important to
consider, in the first place, the evidence of the two parties between
whom any tacit
agreement, if it did come into existence, arose i.e.
the appellant and Dr van der Merwe.
[42]
The appellant was initially recruited into
the trial through Dr Hannelie du Toit during a consultation in
Worcester on Friday 10
June 2005. He had undergone surgery for
colorectal cancer and was a suitable candidate for inclusion in the
trial. On that same
day Dr du Toit provided the appellant with a copy
of the PIL-ICON which he read and discussed with his wife. Shortly
thereafter
he resolved to join the trial and telephoned Dr du Toit on
13 June 2005 to tell her of his wish to do so. By then he had already
decided to participate in the trial on the strength of what Dr du
Toit had informed him. Prior to committing to the trial he had
not
concerned himself unduly with the PIL-ICON because the terms which
were used therein were beyond him. He added that, as far
as he was
concerned, there were no risks attached to the exercise.
[43]
The appellant consulted with Dr van der
Merwe of GVI Oncology two days later. He testified that he had little
recollection of what
his discussion with Dr van der Merwe entailed
besides that the latter had taken him point for point through the
PIL-ICON and endeavoured
to explain to him in layman’s terms
what every single clause meant. He could not recall whether the name
of FHLR was used
during the discussion but in any event the identity
of the party undertaking to pay medical compensation in the event of
a trial-related
injury had been of no concern to him. He had also not
been concerned whether the trial was being controlled from within or
outside
South Africa.
[44]
The appellant testified that he had
understood that in order to participate in the trial (and derive the
benefits) he had to sign
the PIL-ICON; furthermore, that when he
signed it he understood he was giving his assent to all that appeared
above his signature.
The appellant even went so far as to testify
that it was ‘
irrelevant’
to him who was sponsoring the trial.
[45]
The appellant initially testified that it
was possible that he had read the PIL-ICON’s compensation
clause but then testified
that he would have read the sentence that
provided
FHLR
would pay for the costs of medical treatment. The appellant conceded
that this portion of the PIL-ICON made it clear who would
be
responsible for any such costs.
[46]
The appellant admitted that he had seen
that the party undertaking to pay his medical costs in the event of a
trial-related injury
was FHLR and testified further that he was not
aware of any other company, besides FHLR, which bore the name
‘
Roche’
.
[47]
The following exchange in the appellant’s
examination in chief is illuminating in regard to who he intended to
contract with:
‘
Maar
U weet dat as daar ‘n kontrak is, daar is meer as een party …
U
is die een party aan hierdie kontrak? ... --- Dis korrek …
U
het nie omgegee wie die ander party was aan hierdie kontrak nie? ---
Nee, ek het geweet wie die ander party op die tafel is.
Wie
sê u is die ander party? --- Die ander party wat ek op die
tafel gehad het daar was GVI Oncology.’
[48]
The appellant’s belief that he had
contracted with GVI was borne out by his facsimile letter to Dr van
der Merwe on August
2005 in which he demanded that “they”
accept all responsibility for medical expenses arising out of his
injury. The
“they” (or more accurately the “u”)
referred to in his letter was, as the appellant testified, a
reference
to GVI Oncology, another indication that, at least as far
as the appellant was concerned, his agreement was
not
with the respondent.
[49]
If, as he had testified, the appellant had
read the PIL-ICON he would have seen that it bore the name of FHLR on
the top of the
first page and contained an invitation by that company
to participate in the trial. He would, moreover, have read its
address which
would have made it apparent that it was a Swiss
company. As was pointed out by the trial judge, FHLR’s name
appeared 24 times
in the PIL-ICON and the respondent’s name not
at all.
[50]
In the final analysis the appellant
testified that he had read the PIL-ICON, understood the purpose of
the medical trial as well
as its principal advantages and risks, and
that on three separate occasions in the PIL-ICON he had given his
consent to participate
to FHLR.
[51]
Finally, the appellant admitted that, had
he read through the PIL-ICON, which he testified he did, the identity
of the other party
to the contract would have been apparent to him;
it was, however, something that was irrelevant to him:
‘
En
as u hierdie inligtingstuk gelees het dit vir u duidelik gewees het
wie die ander party is tot hierdie kontrak in die inligtingstuk.
---
As ek daarin belangestel het om te weet, ja, edelagbare.
Dit
is die punt, as u belangestel het sal dit vir u duidelik geweet het,
nie waar nie? --- Dit was vir my irrelevant, dis vandag
nog
irrelevant, edelagbare.’
[52]
Thus on the appellant’s own evidence
of the occasion on which any tacit contract was concluded, namely,
during his initial
consultation with Dr van der Merwe, it is
difficult to discern the basis for such an agreement between him and
the respondent,
as opposed to FHLR. This impression is strengthened
when one has regard to the evidence of Dr van der Merwe, who, on
behalf of
the respondent, is alleged by the appellant to have entered
into a tacit agreement with him to pay full compensation in respect
of the consequences of medical injuries which he might sustain as a
result of his participation in the trial.
[53]
Dr van der Merwe testified, moreover, that
he would have made it very clear to the appellant that he would not
be entitled to receive
anything more than medical costs. In this
regard he had used a humorous analogy of a patient growing green
horns and a green tail
as a side-effect of using the trial
medication. In that event, he had explained to the appellant, ‘
Roche’
would pay for the medical costs of removing these growths but not for
the inconvenience which they may have caused.
[54]
Even if Dr van der Merwe had discussed the
identity of the party which would pay for any trial-related injuries
which the appellant
sustained he would not have mentioned the
respondent. He testified that as he understood the position at that
time, any decision
to pay for medical costs ultimately would have to
be made by and from Switzerland.
[55]
Of particular significance is the fact that
Dr van der Merwe was himself unaware of any distinction between the
respondent and FHLR.
In this regard he testified that, in dealing
with the appellant, he regarded himself as representing GVI Oncology
and the entity
which he regarded as the sponsor, namely, the Swiss
company that was paying for the trial and leading it and which he
referred
to as Roche International. He testified further that he
considered ‘
Roche’
a Swiss company and the sponsor of the trial and did not even know
that the trial’s monitor, Ms Matthai, was employed by
the
respondent. As far as he was concerned, in the event of a
trial-related injury the payment of medical costs would come from
Switzerland and was merely facilitated locally.
[56]
Given the fact that the PIL-ICON refers
repeatedly and exclusively to FHLR and Dr van der Merwe’s
apparent lack of any independent
authority to represent or contract
on behalf of the respondent, the appellant sought to contend in
effect for two concurrent compensation
undertakings; firstly, the
express undertaking by FHLR contained in the PIL-ICON and, secondly,
a tacit undertaking or agreement
by the respondent. In support of
this tacit agreement the appellant appears to rely upon on various
provisions and terms in the
respondent’s application for
approval of the trial to the MCC, the SAGCP and ABPI guidelines, the
agreement between FHLR
and the respondent and that between the latter
and GVI Oncology.
[57]
However, the appellant’s own evidence
was that he was at all material times unaware of the respondent’s
existence and
never saw its application to the MCC nor the various
agreements between the aforementioned parties involved in the trial
notwithstanding
that these documents were cited in aid of the
appellant’s case in his particulars of claim.
[58]
Importantly, although the appellant pleaded
in his particulars of claim that the substance of the explanation
which he received
from Dr van der Merwe was that compensation for any
medical injury would take place locally and through a South African
entity
(the respondent), this was not borne out by his evidence. He
could not independently recall whether anything was said to him
regarding
the identity of the party which would pay compensation for
trial-related injuries. As far as he was concerned the identity of
the
payer was irrelevant to him and he was indifferent as to where it
was based. He knew that the undertaking in the PIL-ICON was limited
to medical costs and he did not testify that he was led to believe
that he was entitled to anything more.
[59]
An obvious question is why, had the
respondent indeed wished to enter into an agreement with the
appellant to pay him compensation
for any trial-related injuries, it
did not do so explicitly in an agreement, if needs be in the
PIL-ICON.
[60]
It is improbable, in my view, that there
existed an additional agreement or undertaking on the part of
respondent to pay compensation
for medical injuries arsing out of the
trial i.e. over and above that furnished by FHLR in terms of the
PIL-ICON. Not only does
the appellant run up against the same
difficulty which faced the appellant in
McDonald
v Young,
namely, contending for an
agreement at odds with one explicitly reached, but a parallel
agreement would have been unnecessary and
confusing. There was
evidence, furthermore, that the respondent had been responsible for
adapting Roche’s global PIL-ICON
for use in the South African
trial. Had it wished to do so, therefore, it would have been a simple
matter for the respondent to
delete all references therein to FHLR
and to have undertaken the obligation to compensate trial
participants for medical injuries
itself. To add to the improbability
of it having assumed direct responsibility is the fact that the
respondent had no independent
resources to pay for any medical
compensation claims. It ran the South African trial on the basis of a
budget which it submitted
to FHLR. There was no evidence or
suggestion that this budget made provision for possible medical
expenses of this nature. All
the evidence before the Court a quo was
that after securing FHLR’s agreement to pay for medical costs
arising out of a trial-related
injury the respondent paid, or at
least undertook to pay, these upfront and then recover them from
FHLR.
[61]
On behalf of the appellant Mr van Riet
contended that the respondent was the ‘
sponsor’
of the trial in South Africa and, as such, in terms of the SAGCP
guidelines was obliged to compensate trial participants for
trial-related
injuries. However, in this regard the SAGCP guidelines
require only that the principal investigator should be a South
African based
scientist, as was the case. Furthermore, it is
significant that the same guidelines make provision for contract
research organisations
(CRO’s) to facilitate the carrying out
of clinical trials in South Africa, which entities do not become
liable either for
the costs of or the payment of compensation. Nor
is there any statement in the SAGCP guidelines imposing an obligation
on
the sponsor to pay compensation, the requirement simply being that
there be an explanation of the compensation available for the
patient/volunteer.
[62]
In any event, on a proper reading of the
documentation and understanding of the process, although the
respondent may have implemented
the trial locally it was not its
sponsor. The application to the MCC indicated in terms that the
sponsor was FHLR and where, in
one or two sections of the
application, it indicated otherwise, this was clearly a mistake.
Although FHLR transferred certain of
its functions to the respondent,
as in effect its local agent, it did not transfer to the respondent
its obligation to compensate
patient/volunteers for trial-related
injuries. This much appears from the agreement between these two
parties read together with
para 4.5 of the SAGCP which provides that
any duty and function ‘
not
specifically transferred to and assumed by a CRO (contract research
organisations) are retained by the sponsor’
.
The respondent’s position was, for all intents and purposes,
akin to that of a CRO. Moreover the evidence led by the respondent
was that although the respondent paid, in the first place, for
medical costs arising out of trial-related injuries in South Africa
this was always after FHLR had approved same and subject to the
respondent claiming them back from FHLR.
[63]
Another aspect or circumstance relied upon
by the appellant was the requirements of medical ethics, the argument
being that these
required that the compensation undertaking had to be
given by a South African entity and be executable in South Africa.
This contention
was bolstered by the argument that in the absence of
the tacit agreement relied upon the appellant would have to sue in a
Swiss
court for such expenses and/or compensation to which he laid
claim.
[64]
This argument is flawed at a number of
levels, both theoretical and practical. Subject to satisfying the
prerequisites for such
an action, there is no absolute bar to the
appellant suing a Swiss-based company in a South African court.
Secondly, the process
of applying to and through the MCC for approval
of a trial entailed a scrutiny of the application against the
provisions of the
SAGCP guidelines which in turn give effect to the
principles contained in the Declaration of Helsinki adopted by the
World Medical
Association in 1964 dealing with Ethical Principles for
Medical Research involving Human Subjects.
[65]
The SAGCP guidelines do not stipulate that
compensation must be offered. They provide no more than that:
‘…
Both the
informed consent discussion and the written informed consent form and
any other written information to be provided to participants
should
include explanations of the following:
…
(k)
the compensation and/or treatment available to the subject in the
event of trial-related injuries.’
[66]
It is also significant that the ABPI
guidance note concerning items that should be covered in the patient
information sheet states
as follows:
‘
Explain
that compensation may be available for any injury attributable to
administration of a medicinal product within the trial
or any
clinical intervention or procedure provided for by the protocol that
would not have occurred but for the inclusion of the
patient in the
trial. Record that compensation will be considered in accordance with
the “Clinical Trial Compensation Guidelines”
issued by
ABPI …, where applicable, and inform the patient that a copy
of guidelines can be made available on request.’
[67]
In any event, even were the ethical
position to be that full compensation should have been offered (and
by the local entity) this
would constitute no more than a single
building block in establishing a tacit agreement to the effect that
such compensation was
offered and accepted.
[68]
In the final analysis I am satisfied that
all the evidence, including that indicating the procedure followed by
Dr van der Merwe
and the respondent’s local representatives
following notification of the SAE which the appellant sustained, all
bear out
the terms captured in the contractual arrangement, namely,
that such expenses, if met by anyone, would be met by FHLR. It will
be recalled that Dr van der Merwe, in the face of an initial negative
decision, motivated for the appellant’s medical costs
to be met
by seeking to persuade the
overseas
team involved in the trial study that the injury flowed out of the
appellant’s participation in the trial. The respondent’s
local representatives only agreed to reimburse the appellant for his
medical expenses once the decision had been taken by the overseas
representative.
[69]
It also bears mentioning in this regard
that the appellant was not left without a remedy for the consequences
of his injury. The
evidence is clear that FHLR was willing to
compensate him in accordance with the ABPI guidelines and in fact
agreed to subject
itself to an arbitration process to fix the amount.
It appears, however, that the appellant was unwilling to accept this
process
and instead sought a declaration to the effect that the
respondent was obliged to compensate for the full damages which he
had
suffered, as would be awarded by a British or South African
court.
[70]
Having regard to the evidence as a whole I
am unpersuaded that the Court a quo erred in finding that the
appellant had failed to
establish the tacit agreement for which he
contended. As a starting point I consider that the appellant failed
to establish that
Dr van der Merwe had any actual authority, either
expressed or implied, to conclude a contract with the appellant on
any basis
other than that contained in the PIL-ICON. Further, in my
view the appellant’s evidence alone fell well short of
establishing
unequivocal conduct, capable of no other reasonable
interpretation than that the appellant and the respondent intended to
and in
fact contracted that the latter would be liable for the
appellant’s full damages in the event of him sustaining a
trial-related
medical injury.
[71]
What the appellant seeks through the device
of a tacit contract is the imposition of a full compensation
obligation on the respondent
on an ethical or policy basis. This
approach is misconceived, however. It goes almost without saying that
should the MCC consider
thus a policy appropriate it can make such a
condition an obligation a prerequisite for the holding of a medical
trial in this
country.
[72]
These
findings, strictly speaking, render it unnecessary to determine the
precise ambit of the compensation which was in fact offered
by FHLR.
For the sake of completeness, however, I record that I find myself in
agreement with the conclusion reached by Fourie
J, namely, that in
terms of the PIL-ICON, read together with the provisions of the ABPI
guidelines, such compensation as was offered
by FHLR fell short of a
legal commitment. It amounted to the possibility of compensation on
an
ex
gratia
basis, on the best case scenario in accordance with the compensation
that a British court would accord. That view is in accordance
with
the decision of a British court in
Morton
James Wylie v Dr Donald Grosset, Greater Glasgow Health Board
[7]
where
it was held that the ABPI guidelines did not impose a legally
enforceable obligation. The Court held that the words ‘
Broadly
speaking, the ABPI guidelines recommend that the sponsor without
legal commitment, should compensate you without you having
to prove
that it is at fault’
did
not amount to a guarantee that compensation would actually be paid.
[73]
In the result I find that there is no merit
in the appeal.
COSTS
[74]
In the ordinary course the respondent would
be entitled to his costs on appeal. However, after enquiry with the
respondent’s
counsel, we were subsequently advised that the
respondent was prepared to forego its claim for costs in the appeal.
[75]
In the result the order is simply that the
appeal is dismissed.
_____________________
BOZALEK
J
I
agree.
______________________
DLODLO
J
I
agree.
______________________
SCHIPPERS
J
APPEARANCES
For
Appellant: Mr RS Van Riet SC
Instructed
by:
VanDerSpuy
Cape Town
For
Respondent: Mr WRE Duminy SC
Mr
D Melunsky
Instructed
by:
Edward
Nathan Sonnenbergs
[1]
2002
(6) SA 236
(C) at paras [30]
[2]
2012
(3) SA 1
(SCA) at page 11F – G
[3]
See
Joel
Melamed and Hurwitz v Cleveland Estates (Pty) Ltd
1984 (3) SA 155 (A)
[4]
Standard
Bank of SA Ltd and Another v Ocean Commodities Inc and Others
1983
(1) SA 276
(A) at 292 B-D
[5]
See
Corbett JA in
Joel
Melamed
at 164I – 165A
[6]
[2014]
ZAWCHC 8
(A391/2012,
3541/2012) (10 February 2014)
[7]
[2011]
COSH 89 at para [22]