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Appeals : Arbitrator
Decisions : #126 - February 27, 2004
D E C I S I O N
Claim No. 1787
Province of Infection - New Brunswick
1. The Claimant applied for compensation as a Primarily-Infected
Person pursuant to the Transfused HCV Plan.
2. By letter dated March 1, 2002, the Administrator denied
the claim on the basis that the Traceback results confirmed
that no donors of the blood transfused to the Claimant during
the Class Period tested positive for the HCV antibody.
3. The Claimant requested that the Administrator's denial
of her claim be reviewed by an arbitrator.
4. Both parties waived the requirement for an oral hearing.
5. The relevant facts are not in dispute and can be summarized
as follows:
(i) The Claimant was transfused with two units of blood
on April 19, 1998 at the time of the birth of her second child.
(ii) At the request of the Administrator, the Canadian Blood
Services conducted a Traceback on the two units.
(iii) The results of the Traceback were that the donors
of neither of the units tested positive for the HCV antibody.
(iv) One of the two donors was tested by an independent
laboratory using the latest testing criteria under the HCV
3.0 EIA approved by Health Canada.
6. In a letter dated June 10, 2002, the Claimant raised a
number of questions. The letter reads in part as follows:
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"There are many possibilities for having
a negative result to the Hepatitis C testing. Can the
following questions be answered without a reasonable doubt? |
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Units of blood can have many donors have
all mine been located? |
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Are you 100% sure the virus and antibody
has not left the donors body before Hepatitis C testing
was done? |
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Donor for Unit #A048746-1 has a note in
testing generation box that states 'Tested at a facility
other than CBS Laboratory, testing generation not specified'.
Why is this? Copy of letter enclosed. |
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Has the test results for donor of Unit #A048746-1
been validated? |
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Did I receive any blood products during
surgery one year after that transfusion?" |
7. Fund Counsel responded to these questions in his written
submissions as follows:
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7. In a recent decision by Mr. Justice Pitfield [claim
no. 1300593], His Lordship discussed the purpose of the
traceback. He also discussed the interplay between sections
3.04(1) and 3.04(2) (the 'notwithstanding' provision)
of the Agreement. In doing so, he stated:
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'[9] Article 3.04(1) provides that the Administrator must
reject a claim for compensation if either of two conditions
is satisfied: the Claimant received blood prior to January
1, 1986 and the traceback in respect of that transfusion
indicates that the blood donor was infected with the Hepatitis
C antibody, or the Claimant received a transfusion or
transfusions in the class period and the traceback in
respect of that or those transfusions indicates that neither
the donor nor donors of the blood transfused in the class
period tested Hepatitis C antibody positive.
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[10] Article 3.04(2) provides an exception to Article
3.04(1). Notwithstanding traceback results, a claimant
may prove that he or she was infected with the Hepatitis
C antibody for the first time by a blood transfusion received
in the class period. The Settlement Agreement is silent
with respect to the applicable burden of proof and the
nature of the evidence that might refute the traceback
result.
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[11] A number of observations are warranted in the face
of Article 3.04. First, the principal basis specified
in the Settlement Agreement for the purpose of determining
eligibility is receipt of an infected transfusion in the
class period. However, receipt of an infected transfusion
in the class period is insufficient to establish eligibility
if the Claimant also received an infected transfusion
prior to the commencement of the class period. In addition,
a Hepatitis C infected person is prima facie ineligible
if the traceback in respect of class period transfusions
demonstrates that none of the donors of that transfused
blood tested positive for the Hepatitis C antibody.
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[12] While those who are infected with Hepatitis C but
denied coverage because of Article 3.04 might feel aggrieved,
the provisions of the Settlement Agreement were proposed
by counsel for all parties and endorsed by the supervising
courts in British Columbia, Ontario and Quebec. The traceback
protocol by which eligibility is to be assessed initially
was endorsed by the supervising courts. Because tests
to identify the presence or absence of the Hepatitis C
antibody had not been conducted in the class period, the
protocol provided that steps were to be taken to identify
the donors of the blood transfused to a claimant in the
class period, whether those donors donated blood after
the close of the class period, whether those subsequent
donations were tested for the Hepatitis C antibody, and
whether the result of the test was positive or negative.
If the donor could not be identified or had not made a
later donation of blood, antibody test results were not
available in relation to those later donations, or the
HCV antibody test results were positive, the Claimant
was eligible for compensation.
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[13] The traceback protocol was developed in accordance
with prevailing science. The Settlement Agreement and
the protocol were approved by counsel for the members
of the class and the defendants, and subsequently by court
order. The protocol was considered the best means of relating
infection to blood transfusion for which the Settlement
Agreement is intended to compensate.
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[14] While the primary basis for the determination of
eligibility is the traceback process, a Claimant may adduce
evidence on appeal in support of the claim that he or
she was infected for the first time in the class period
notwithstanding a negative traceback result. In my opinion,
Article 3.04(2) does not permit a Claimant to conduct
his or her own traceback procedure. The Article contemplates
that there might be evidence which would establish that
the source of the infection, more likely than not or on
the balance of probabilities, was a transfusion received
in the period. It is not an answer to a Claimant's attempt
to provide such evidence to say that some small percentage
of the population may be infected by HCV from unknown
sources. Were such an assertion an answer, a Claimant
could never refute the traceback result because the Claimant
could never prove that he or she was not one of that small
percentage of the population who might have been so infected.
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[15] The evidence the Claimant would be required to adduce
on appeal would include, at the least, complete family
and personal medical history and detailed evidence of
all aspects of the Claimant's lifestyle including evidence
of the absence of opportunity to be infected by needles
or injections, however and for whatever purpose received.
The kinds of evidence I have described are not intended
to be exhaustive. Rather they are intended to point to
the process that must be followed in the attempt to refute
the traceback result.
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[16] A simple denial by a Claimant of personal history
or actions that have been identified as potential non-transfusion
sources of HCV infection will not suffice. The reliability
of the assertion which is subjective in nature would have
to be tested by reference to all known objective evidence.
One of the pieces of objective evidence is the negative
traceback result following upon the application of, and
adherence to, the approved traceback protocol. Contradictory
objective evidence would have to be very persuasive if
the traceback result is to be refuted.'
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Accordingly, in challenging the traceback, a claimant must
demonstrate something specific to the claimant and not in
respect of the traceback generally.
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8. In response to the issue raised in the appeal, the
Administrator took steps to clarify some of the issues
raised in Ms. 's appeal. In respect of the donors for
the 1988 transfusion, the CBS has opined that they have
located all the donors of the units of blood received
in 1988 (see April 18, 2002 letter of CBS).
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9. In respect of the second issue of whether the virus
or antibody have left the donors, the Administrator has
two responses in respect of this issue.
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(i) As indicated in Mr. Justice Pitfield's decision, the
traceback is a court sanctioned control mechanism in respect
of the settlement agreement. The requirement is for the
Administrator to conduct a traceback and determines that
'none of the donors or units of blood received by a primarily
infected person or opted-out primarily infected person
during the class period is or was HCV anti-positive' then
the Administrator must deny the claim. The requirement
applies equally to the donors as to the units of blood
transfused. The agreement is that a transfused plan is
clear that if none of the donors is HCV antibody positive'
then the Administrator does not have the discretion to
look behind the traceback in Section 3.04(1).
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(ii) Having said this, the issue of clearing antibodies
has been raised in other cases. In claim no. 1300323 (decided
before Mr. Justice Pitfield's decision), the Claimant
was in a similar position as Ms. . The Claimant was transfused
in 1988. There were two donors identified with the Claimant's
1988 transfusions. Like Ms. , one donor had been tested
for the HCV antibody in April 1993 as part of the routine
screening process when an individual donates blood in
Canada. This is the same as donor of 048747-2 who was
determined to be negative as of May 1990. The other donor
in claim no. 1300323 was tested for the antibody in January
2001 as a result of a followup to the application and
that donor was tested negative for the HCV antibody. Similarly,
Ms. ' s donor associated with unit no. 048746-1 was tested
as being antibody negative in March 2001 (see CBS's letter
dated August 27, 2002).
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Testimony given by Dr. Kleinman in claim no. 1300323 helps
to explain the traceback procedure and the Administrator's
ability to rely on the traceback test results. The following
quotation is taken from the decision in claim no. 1300323
(copy enclosed).
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'Dr. Kleinman also testified that Hepatitis C Traceback
investigations are conducted to establish whether a blood
donor may have been infected with Hepatitis C virus at
some time in the past which [sic] that the donor may have
transmitted the infection to a recipient via a blood transfusion.
Often, as in this case, testing of a follow up sample
from a former blood donor will occur years after the transfusion
incident under investigation. The first donor was tested
five years after the transfusion under investigation.
The second donor was tested thirteen years later. According
to Dr. Kleinman, Hepatitis C antibody testing detects
a response of the infected person's immune system to exposure
to the Hepatitis C virus. This response generally occurs
within the first several months after exposure to the
virus. Once such a response occurs, it is long lasting
and will last for decades and probably for life in the
vast majority of people.
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Dr. Kleinman also testified that the Hepatitis C antibody
will persist both in persons who remain infected with
Hepatitis C as well as in persons whose immune system
has been successful in eradicating the Hepatitis C viral
infection. Dr. Kleinman also gave evidence that Hepatitis
C antibody testing has been proven by several long term
studies to be more effective than PCR testing in detecting
evidence of previous Hepatitis C infection. Those studies
show that 20 to 45% of persons known to have been previously
infected with HCV will test positive for the antibody
but negative for the virus by PCR testing at approximately
17 to 23 years after initial infection.'
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In claim no. 1300323, the Arbitrator accepted Dr. Kleinman's
opinion that a donor who made a donation 13 years previously
would no longer have the antibody such that they would
have been positive at the time of the donation but negative
at the time of testing. Accordingly, even it is appropriate
to attack the traceback process, it is submitted the issue
raised by the claimant has been addressed in earlier cases.
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10. The Claimant also raises the fact that Unit A048746-1
was tested in a facility other than the CBS Laboratory.
LDS Laboratories has to confirm to CBS that it utilized
HCV3.0EIA which is approved by Health Canada. In earlier
cases, an issue was raised whether CBS was entitled to
rely on its predecessor the Canadian Red Cross Society
testing (attached). Mr. Justice Pitfield held that CBS
was not required to repeat the procedure. Given LDS Laboratories
was utilizing an approved Health Canada screening it is
appropriate for CBS to rely on that test.
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11. Finally, the Claimant indicated she may have been
transfused during surgery one year after the transfusion.
As a result of this information, the Administrator made
further inquiries to determine whether or not there was
a subsequent transfusion. It was determined that the attendance
referred to by the Claimant was a surgery at St. Joseph's
Hospital, Saint John, New Brunswick in 1989. As a result
of several pieces of correspondence, it was determined
by the CBS based on information provided by the hospital
that there was no transfusion at that time (see letters
dated April 10, 2003 and attached report and March 5,
2003 and attached report)."
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8. The Claimant did not make any written submissions despite
being invited on several occasions to do so.
9. On the evidence presented to me, I am left with no alternative
but to find that the Claimant was only transfused on one occasion
during the Class Period - namely, on April 19, 1998. I further
find that the Traceback results demonstrate that none of the
donors of the blood received by the Claimant at that time
was HCV antibody positive. Accordingly, subject to the provisions
of Section 3.04(2), the Administrator was required to reject
the present claim.
10. Section 3.04(2) provides, in part:
| "(2) A claimant may prove that the relevant Primarily-Infected
Person...was infected, for the fist time, with HCV by
a Blood transfusion received in Canada during the Class
Period..., notwithstanding the results of the Traceback
Procedure. For greater certainty, the costs of obtaining
evidence to refute the results of a Traceback Procedure
must be paid by the claimant unless otherwise ordered
by a Referee, Arbitrator or Court." |
11. I adopt Justice Pitfield's reasoning in claim no. 1300593
with respect to the application of Article 3.04(2). In order
to refute the Traceback results, a simple denial by the claimant
of personal history or actions that have been identified as
potential non-transfusion sources of HCV infection is not
sufficient to refute the results of the Traceback Procedure.
Certainly, there is nothing here which resembles the comprehensive
medical history and detailed evidence which would be necessary
to overcome the prima facie ineligibility of the Claimant
which flows from the Traceback results pursuant to Section
3.04(1).
12. It goes without saying that one cannot help but be sympathetic
towards the Claimant and the plight in which she finds herself.
However, the role of the Administrator under the Settlement
Agreement is to administer the Transfused HCV Plan in accordance
with its terms. The Administrator does not have the authority
to alter or disregard the terms of the Plan, nor does an arbitrator
when called upon to review decisions of the Administrator.
13. In the result, the Administrator's denial of the Claimant's
request for compensation is hereby upheld.
DATED at Halifax, Nova Scotia, this 27th day of February,
2004.
S. BRUCE OUTHOUSE, Q.C.
Arbitrator
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