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Appeals: Confirmed
Referee Decisions : #93 - April 16, 2003
Referee decision as to Costs attached
- December 17, 2003
D E C I S I O N
1000367 was born in 1932. At age 56, she was admitted to
the Ottawa Civil Hospital for heart surgery. On July 6, 1988,
she was given a single unit blood transfusion. Approximately
one month later, she was admitted to Belleville General Hospital
where a diagnosis of acute Hepatitis (non-A-non-B) was made.
To be eligible for compensation under the HCV Transfused
Plan, the Primarily-infected Person must have received a blood
transfusion, during the class period, from a donor who is
determined to be infected with Hepatitis C. The transfusion
was during the class period.
It is the procedure of the Canadian Blood Services ("CBS")
to do a traceback on the transfused unit. The result of this
traceback was summarized in a letter, dated June 8, 2000,
from CBS, stating that 1000367 had received 1 unit of Red
Cells in 1988 and the donor of this unit was tested and found
to be negative for Hepatitis C. Further testing of the donor
resulted in continued negative results for Hepatitis C. On
this basis, the Administrator rejected the claim. Further,
the Administrator concluded that 1000367's death was not caused
by her HCV infection.
There are two bodies of contradictory medical opinion to
be considered. Dr. Ashok Khanna of Orlando, Florida, was the
treating physician at the time of death. Three short letters
of Dr. Khanna state:
Letter dated May 25, 2000
This is to certify that [1000367] whom I took care of in
Sandlake Hospital, was critically ill and had multiple tumors
on her liver and her lungs.
A copy of the surgical pathology report from the Belleville
General Hospital, dated 08/25/88 showing acute viral hepatitis
and the report from Dr. J. Heathcote of the liver clinic of
Toronto Western Hospital, dated 10/18/90 stating that the
Hepatitis C test was positive, along with my copy of her last
chest x-ray at the Belleville Hospital, dated 05/12/94 stating
that her lungs were clear lead me to the conclusion that the
hepotocellular carcinoma originated in her liver and spread
to her lungs.
There was definitely physical evidence of cirrhosis of the
liver, unfortunately due to the weakened condition of the
patient we were unable to do a liver biopsy.
The patient had suffered from transfused injected Hepatitis
C since 1988 and it caused her early demise. She was admitted
to the Sandlake Hospital on 03/17/96 and expired while being
air-vac'd to Canada on 03/21/96.
Letter dated July 26, 2001
Re: [1000367]
I saw the above named patient at Sandlake Hospital on March
17, 1996. She had decompensation of her liver as evidenced
by Liver Enzyme Derangement, Coagulopathy and a Jaundice appearance.
A Cat Scan revealed numerous metastic tumors in her liver
which inevitably spread to her lungs. This is all consequently
due to her having Hepatitis C and Cirrhosis of her liver leading
to Hepatocellulor Carcinoma. In my opinion she received tainted
blood which lead her to Hepatitis C and sequel resulting in
her premature demise.
Third Letter
I am writing this letter regarding [1000367] who I treated
at Sand Lake Hospital in 1996. Patient at that time was acutely
ill. She suffer from Hepatitis C and had respiratory failure.
Chronically infected with Hepatitis C on the date of admission
she was found to have metastatic cancer. Our intention at
that time was to have a biopsy from target organ liver but
due to her severely decompensated state we were unable to
do a biopsy. Had we done the biopsy at that time, it would
have revealed evidence of Hepatitis C and cirrohsis (as we
did not palpate any enlarged liver - cirrohsis cause shrinking
of the liver). I believe that chronic hepatitis C had developed
into hepato-cellular carcinoma and then spread to the lungs.
I had reviewed Dr. Kleinman and others physicians notes. I
do not agree with Dr. Kleinman opinion because prior to her
coming to Orlando there was no reported illness of the lungs
whereas she suffer from Hepatitis C which I believe has cause
to her death.
Dr. Russell Scott says 1000367 suffered from transfusion inflicted
Hepatitis and that she had no Hepatitis before attending the
Ottawa Civic Hospital.
Dr. William Depew, Department of Medicine (Gastroenterology),
Queen's University, concludes that it is reasonable that 1000367
acquired Hepatitis C at the time of her blood transfusion.
He also stated that 15 to 20% of individuals may acquire the
infection from a source that no one can pin point. The acquisition
date of Hepatitis C is almost precisely at the date of her
heart surgery, in July 1988. Dr. Lietaer and Dr. Heathcote
felt the Hepatitis was secondary to her blood transfusion.
Dr. Robertson, in a discharge summary, felt that the Hepatitis
was transfusion-related.
Thus, six doctors - Khanna, Depew, Scott, Lietaer, Heathcote
and Robinson - believe the transfusion caused the Hepatitis.
On the defence side, Dr. Diaz-Mitoma and Dr. Kleinman take
a different view, though neither of them ever examined the
patient.
The traceback protocol contemplated by the Plan indicates,
according to Dr. P. Lesley, Assistant Medical Director, CBS,
that the tests were negative with no laboratory evidence for
Hepatitis C.
It is significant to me that two treating physicians, Dr.
Khanna and Dr. Depew, found evidence of jaundice and concluded
that the carcinoma spread from the liver to the lungs.
Dr. Steven Kleinman testified for the Administrator. He
is a clinical professor of pathology at the Faculty of Medicine,
University of British Columbia and an adjunct scientist to
CBS. I accept him as an expert on blood-related diseases,
blood screening and tracebacks. The Canadian Blood Service
concluded that there is no laboratory evidence to support
Hepatitis C infection from the transfused blood product.
The Administrator denied the claim on the basis that there
was no evidence that the claimant was infected for the first
time with HCV via blood transfusion received in Canada during
the Class Period. I am satisfied that the Administrator properly
relied on the traceback procedure in rejecting the claim.
However, section 3.04(2) says a claimant may still prove a
claim notwithstanding a negative traceback.
Dr. Kleinman co-authored an article in July 1997 in "Transfusion
Medicine Reviews", which contained the following:
Although each donated unit of blood is tested for evidence
of infection by specific viral agents, there are at least
four potential reasons why transmission of these viral agents
still might occur. The primary reason is that the donor has
negative laboratory test results during the early stages of
infection, known as the window period. A second factor contributing
to the risk of transfusion-transmitted infection for some
agents is the existence of a chronic carrier state in which
a clinically asymptomatic donor will persistently test negative
on a donation screening assay. Thirdly, a viral agent may
have a large enough degree of genetic diversity so that laboratory
screening tests fail to identify some infectious donors who
harbor a particular atypical genetic variant. A fourth factor
contributing theoretically to a possible transfusion-transmitted
infection is laboratory error in performing the screening
tests; however, given the low prevalence of infected donors
and the high accuracy of automated testing, the occurrence
of such errors is thought to be extremely rare.
I hasten to note that the facts of this case do not fall in
the "window period". It seems to me that it is because
of this kind of awareness that those who drafted the Plan
included Article 3.04(2).
In this case, there are no other risk factors present other
than the transfusion. There appears to be no other explanation
for the timing of Hepatitis C other than the transfusion.
I accept the evidence of the treating physicians that the
transfusion was the cause of the infection. This appeal is
allowed with costs.
I would be remiss if I failed to compliment both counsel
on the excellence of their advocacy.
Dated at Toronto, this 16th day of April 2003.
The Honourable Robert S. Montgomery Q.C.
Referee
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