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Appeals :Confirmed Referee Decisions : #56 - September 5, 2002

D E C I S I O N

A. Introduction

[1] The Claimant applied for compensation as a Primarily-Infected Person pursuant to the Transfused HCV Plan ("the Plan").

[2] The Claimant had provided sufficient evidence to the Administrator to support his claim that he had received blood during the period from January 1, 1986 - July
1, 1990 ("the Class Period").

[3] However, by letter dated May 3, 2002, the Administrator denied the Claim, having carefully reviewed the material provided in support of the claim, along with a committee of three (3) senior evaluators, for the following reasons:

The results of your Traceback confirmed the donor of the unit of blood transfused to you, during the class period, has tested negative for the HCV antibody. In light of this information, your claim was denied. You indicated in your response to our first letter that you would be sending in further evidence. The information you submitted was reviewed and did not favourably influence the previous results of your traceback. You submitted a letter dated March 19, 2002 asking the Administrator to make a final decision on your claim. Therefore, based on Article 3.04 of The 86-90 Hepatitis C Settlement Agreement, Transfused Plan, you no not meet the criteria for compensation and your claim is denied.

[4] By way of Request for Review by Arbitrator/Referee (the "Notice of Appeal") dated May 24, 2002, the Claimant requested a review of the denial of his claim by the Administrator. In paragraph 4 of his Notice of Appeal, the Claimant stated that he wished to review the Administrator's decision, for the following reasons:

My claim was denied, and although the trace back came back negative, I have information which clearly states, Hepatitis C can be transmitted through Albumin. The Claims Centre does not recognize this because Albumin is too difficult to trace. The unit I received, I was able to trace it back to Cutter Pharmaceuticals, which is now owned by Bayer Corp. I traced this on the internet …

[5] The Claimant advised that he wished the matter to proceed by way of Reference rather than Arbitration, and he requested an in-person hearing.

[6] At the request of the Referee, each party was kind enough to provide advance written submissions.

[7] Set out below are certain pertinent extracts from the Claimant's written submission:

After months of getting forms filled out, doctors visits, I started getting information that my claim was moving forward, and that a trace back was going to be done, and I'd be hearing from them shortly. I kept calling the claim centre to get the updated status, and each time I'd call, I'd get the same answers; "We are waiting for the trace-back results" or "We're waiting for the information to be scanned." Finally, in August of 2001, I received a letter in the mail telling me that the trace-back came back with the donor having tested negative. All that time, I was told that I would have to provide more proof, or my claim would be denied. I wrote a letter advising the Claim Centre that YOU CAN IN FACT GET HEPATITIS C THROUGH THE USE OF ALBUMIN…

I did not ask for this disease. I was unlucky enough to be injected by Blood Products, from the Canadian Red Cross Society (now the Canadian Blood Services), who are solely responsible for Collecting and Storing, Whole Blood, and numerous other blood products, including Albumin.

In the 1986-90 Hepatitis C Settlement Agreement, in schedule A Transfused Plan 1.01 Definitions.
They explain the definitions very carefully, up until the heading BLOOD. QUOTE: "Blood" means whole blood and the following blood products: packed red cells, platelets, plasma … and white blood cells. Blood does not include Albumin 5%, Albumin 25%, Factor VIII and the list goes on.

At the beginning of the above quote it clearly states BLOOD PRODUCTS. Then just a few lines later it omits 20 blood products out of a possible 24 that they have listed in the settlement plan….

It is my belief that the Canadian Red Cross is solely responsible for my contracting Hepatitis C, and by denying my claim because Albumin is too hard to trace, because of the numerous donors is just plain laziness on their part. Just because something is too hard for them to do is no reason to deny my claim. The Canadian Red Cross gave me the disease I have to live with the rest of my life, and even though I did not get the disease from Tainted Blood, I did get it from another one of their Blood Products. There is absolutely nothing in my past that would have put me at risk as I was not given any blood products. The 1986-1990 Hepatitis C Settlement Agreement clearly puts me at Level 3….
[emphasis added by Claimant]

[8] Fund Counsel's written submissions, sent on July 30, 2002, set out the position of the Administrator. The Administrator concedes that the Claimant had received a unit of blood at Hanna General Hospital (Alberta) on October 15, 1988 (within the Class Period). However, the Traceback of the unit of blood showed that the donor of that blood was negative. Therefore, the blood received by the Claimant on October 15, 1998 was not infected with Hepatitis C. The Administrator also acknowledged that the Claimant had received one unit of 25% Albumin from Hanna General Hospital. In that regard, however, the Administrator further relies on the definition of "Blood" in the Plan, which is as follows:

"Blood" means whole blood and the following blood products: packed red cells, platelets, plasma (fresh frozen and banked) and white blood cells. Blood does NOT include:

Albumin 5%, Albumin 25%, Factor VIII, Porcine Factor VIII, Factor IX, Factor VII, Cytomegalovirus Immune Globulin, Hepatitis B Immune Globulin, Rh Immune Globulin, Immune Serum Globulin, (FEIBA), FEVII Inhibitor Bypassing Activity, Autoplex (Activate Prothrombin Complex). Tetanus Immune Globulin, Intravenous Immune Globulin (IVIG) and Antithrombin III (ATIII).

[underlining added]

[9] An in-person hearing was held in Saskatoon on August 13, 2002. The Claimant testified on his own behalf and Carol Miller, Appeals Coordinator of the Hepatitis C January 1, 1986 - July 1, 1990 Claims Centre (the "Claims Centre"), testified on behalf of the Administrator. In the result, the matter will indeed be adjudicated upon based on the written materials and testimony tendered by the parties.

B. Facts, Summary of Evidence

[10] Pursuant to the terms of the January 1, 1986 - July 1, 1990 Hepatitis Settlement Agreement ("the Settlement Agreement") and the Plan, the Class Period is the only period of time in respect of which compensation may be available. Further, while there are many possible sources of infection with respect to the Hepatitis C Virus ("HCV"), the Plan only provides compensation for individuals who received transfusions of defined blood products during the Class Period.

[11] The Claims Center file, consisting of 93 pages, was entered as Exhibit 1 at the hearing. In the Claimant's General Claimant Information Form (TRAN 1) dated August 22, 2000, the Claimant stated that he believed that he was infected with the HCV through a Blood Transfusion in Canada and that he had received 3 blood transfusions during the class period. In his accompanying Declaration (TRAN 3) dated August 28, 2000 , the Claimant stated that to the best of his knowledge, information and belief, he had resided in Alberta during the Class Period. The Claimant further declared it to be "true" that to the best of his knowledge, information and belief, he "was not infected with Hepatitis Non-A Non-B or the Hepatitis C virus prior to January 1, 1986." In Box 4 on TRAN 3, the Claimant checked off the "true" box beside the declaration that he "has never at any time used non-prescription intravenous drugs." The Treating Physician Form "TRAN 2") was completed by the Claimant's physician on August 8, 2000. Section F - Box 2 was checked off as "yes" following the statement: "Having regard to the definition of blood, the Claimant did receive a blood transfusion during the period January 1, 1986 to July 1, 1990." The physician checked "no" in answer to the question: "Is there anything in the HCV Infected Person's medical history that indicates he or she was infected with Hepatitis Non-A, Non-B or the HCV prior to January 1, 1986?" In Section F, Box 1, with respect to whether the Claimant had a history of risk factors for the Hepatitis C virus other than a blood transfusion during the class period, the physician checked off the box indicating "Prior significant surgeries or trauma." This form also indicated that the physician had known the Claimant since March 6, 2000.

[12] Exhibit 2 is a letter dated August 1, 2002 from the Canadian Blood Services (CBS) to Mr. Callaghan, verifying the percentage of albumin transfused to the Claimant, by Lot Number and Manufacturer (Cutter), as 25% Albumin. Exhibit 3 is a letter dated July 29, 2002 from the CBS to Ms. Miller setting out in considerable detail the particulars of the Traceback procedure undertaken with respect to the Claimant's file. The Unit of Red Blood Cells that was transfused to the Claimant on October 15, 1988 at Hanna General Hospital was identified by unit number and transfusion date. The same applied with respect to the Albumin transfused to the Claimant at Hanna General Hospital on October 15, 1988. The letter goes on to confirm:

No other units were identified in the TRIs ("Transfusion Related Infection Reports") as having being transfused to the Recipient during the class period. CBS has confirmed with Hanna General Hospital that the albumin was 25%. CBS does not conduct traceback investigations on albumin.

The Blood Bank Record from Foothills Hospital … indicated that three units were cross-matched with respect to the Recipient. Please note that the TRI received from Foothills Hospital (attached) indicates that no transfusions were given to the Recipient…

Upon receipt of the Recipient's transfusion information from the Hospitals, CBS Calgary input the unit number transfused, being unit # … into the CBS' Blood Information System ("BLIS database") a computerized information system that tracks blood donor information. The BLIS database allows CBS to link unit numbers to the donors of those units. The donor associated with the unit was identified.

It was determined that the donor associated with unit # …, transfused during the class period, subsequently tested negative for the HC antibody. [The most recent testing results for the donor associated with the class period was dated 1996-10-31.]

The screening test, which CBS currently uses to detect the antibody to Hepatitis C, is HCV 3.0 EIA, which came into use in or about June 1996. Health Canada has approved this screening test for use in Canada. At the time testing of the donor associated with unit # … was conducted, the CRCS operated the blood system in Canada and tested the donor…

The HCV EIA screening test is extremely sensitive and occasionally picks up reactions in healthy individuals who do not have an infection ("false positives.") If any of the screening tests show a reaction that might indicate infection, a further confirmatory test is done to clarify the result. The screening tests conducted on the donor associated with the donation in the class period was negative. Therefore, no confirmatory testing was required.


[11] Exhibit 4 is a letter provided by the Claimant, authored by Dr. J. J. Changela, dated May 21, 2002, which states:

This patient is under my care. He has Hepatitis C and had a full course of treatment, which was done by Dr. Sylwestrowicz. He is now in the remission stage.

Hepatitis C can be transmitted through blood products, Albumin intravenous injections and from other major routs of transmission…
[emphasis added]

[12] Ms. Miller testified to the effect that albumin is a component derivative of blood that is manufactured by drug companies, for example Cutter and Bayer, from blood protein supplied by multiple donors. It does not require cross matching and is useful for providing quick fixes. It is stored in what looks like the old intravenous bottles. While the matter is not free from debate, there is a considerable body of medical evidence that supports the conclusion that albumin is not an HCV transmitter. In this respect, Ms. Miller referred to Arbitrator Decision # 23, dated November 23, 2001, of Vincent Orchard, Arbitrator, which outlines the testimony given in that hearing by Dr. G.H. Growe, Division Head, Hematopathology and Medical Director of the Blood Transfusion Service at Vancouver General Hospital and Health Sciences Centre. At paragraph 13, the decision states:

… Dr. Growe admitted that it is not absolutely impossible that albumin may have been infected with the virus and the amount of albumin administered may be irrelevant; however, albumin is a blood product that is not known to be associated with Hepatitis C or with any other transmitted virus. … He believes that since albumin and streptokinase have been used and are sold all over Canada if there were outbreaks of viruses in the patients who have been administered these products, such outbreaks would have come to public attention or been the cause of investigation.

[13] In reviewing, Exhibit 2, Ms. Miller noted that there was indeed confirmation from the Hanna Hospital that the Claimant had received one 100ML unit of a specified numbered lot of 25% Albumin on October 15, 1988. The Report of TFI confirms that the Claimant also received packed red blood cells on the same date, the donor of which ultimately tested negative for the virus.

[14] In cross-examination, the Claimant voiced concerns as to what he perceived as inordinate delays on the part of the Centre in conducting the traceback. Ms. Miller referred to the Court Approved Protocol, containing the criteria for the Traceback Procedure, which allows for a six-month time frame. In this case, the time period did not start to run until the Centre had all the information it needed. In this case the Claimant's physician in the TRAN2 form checked off the box indicating "prior significant surgeries or trauma". Further, the subsequent broken ankle and hip replacement that the Claimant underwent were risk factors. In the result, additional investigation was required.

[15] The Claimant also asked Ms. Miller how it was possible to conclude, from the 1996 testing of the donor of the packed red cells in question, that the donor did not have the virus at the time of the transfusion in 1988. He suggested that the donor be re-tested. Ms. Miller responded that if the donor did not have the antibody to the virus in 1996, he or she had never been infected with the virus before then. Re-testing the donor at this time would be pointless as even if the donor now tested positive, this would have no bearing on his or her status in that respect as of 1996 of earlier.

[16] In his testimony, the Claimant indicated that when he was 4 he was run over by a car after his sister put the car out of gear, causing him to require plastic surgery on his face. He further testified that on October 15, 1988, while employed working on pipelines near the Hanna Hotel and driving to Drumheller, it was reported to him that he fell asleep at the wheel, thereafter sustaining serious injuries. He did not remember anything while he was hospitalized in Hanna. He recalls waking up in the air ambulance en route to the Foothills Hospital in Calgary. He remained in hospital for 6 weeks, with a fractured right pelvis, hip (requiring 6 screws), partial paralysis, fractured hand and foot. The bones in four toes were replaced with "steel toes." In February 1996, the Claimant required hip replacement surgery at University of Alberta Hospital in Edmonton. He became fatigued and ill in the summer of 1999 or 2000, after which numerous tests were conducted, which unfortunately confirmed the presence of the HCV. He called the Foothills Hospital and was informed that he had received no blood products there. He called the Hanna Hospital and was informed that their health records are destroyed after 10 years and that his were no longer available. He is in remission at this time.

C. Analysis

[17] The following are the material findings of fact in this case:

(a) The Claimant is infected with Hepatitis C.
(b) The probable source of such infection was not established in evidence.
(c) The Claimant did receive one 100 ml unit of 25% Albumin in Hanna on October 15, 1988.
(d) Although he was transfused with one unit of packed blood cells in Hanna on October 15, 1988, the Traceback showed that the donor had tested negative for the HCV, using the most advanced testing available, namely EIA Gen 3.0.
(e) The Claimant did not receive any blood products while hospitalized subsequently for six weeks at the Foothills Hospital in Calgary.
(f) Accordingly, while the Claimant has established that he received a transfusion of blood products during the Class Period, he was unable to establish that the donor of such products was infected with the virus.

[18] While the Claimant's notice of appeal focused on the issue of Albumin, at the hearing, the Claimant continued to express concerns as to the traceback procedure with respect to the packed blood cells. Therefore, both issues need to be addressed.

[19] It is beyond doubt that a Referee's jurisdiction to award compensation to a Claimant is circumscribed by the definition of "Blood" in Article 1.01 of the Plan. Notwithstanding Dr. Changela's views that HCV can be transmitted through Albumin intravenous injections, Albumin 25% is specifically excluded from the definition of "blood." The wording of the Plan Text makes it abundantly clear that the framers did not intend Albumin 25% to fall within the range of potentially compensable products.

[20] This limitation on the jurisdiction of an arbitrator or referee under the Plan is reiterated in the following cases, all of which resulted in the inevitable denial of claims to entitlement to benefits under the Plan where the products received by the Claimant were specifically excluded from the definition of "Blood" in the Plan Text:

Arbitrator Decision # 23, November 23, 2001 (Vincent R.K. Orchard, Arbitrator), involving the administration of Streptokinase, an enzyme used to dissolve blood clots, which is chemically suspended in albumin.

Unconfirmed Referee Decision # 3, June 1, 2001 (Reva Devins, Referee), involving the receipt of Rh Immune Globulin, another product excluded from the definition of "blood" in the Plan Text.

Unconfirmed Referee Decision # 6, June 11, 2001 (Shelly L. Miller, Q.C.), involving the receipt of IV gamma globulin (also known as intravenous Immune Globulin), another product that is specifically excluded from the definition of "Blood".

[21] In the result, to the extent that the Claimant has relied on the receipt of Albumin in support of his claim, his appeal must fail.

[22] With respect to the Claimant's concerns relative to the traceback, some of these may have indeed been addressed to his satisfaction by Ms. Miller's testimony. The Claimant appears to have relied more on the Albumin issue in any case. The Administrator followed the Court Approved Protocol containing the Criteria for Traceback Procedures for Primarily Infected Persons. Having done so, it was then obligated to apply the provisions of the Plan text, which provide:


3.04 Traceback Procedure

(1) Notwithstanding any other provision of this Agreement, if the results of a Traceback Procedure demonstrate that … none of the donors or units of Blood received by a Primarily-Infected Person … during the Class Period is or was HCV Antibody positive, subject to the provisions of Section 3.04(2), the Administrator must reject the Claim …

(2) A Claimant may prove that the relevant Primarily-Infected Person … was infected, for the first 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 Traceback Procedure must be paid by the claimant unless otherwise ordered by a Referee, Arbitrator or Court.
[emphasis added]

[23] Fund Counsel candidly acknowledged that there have been no Arbitrator/Referee or Court cases to date that have allowed a Claimant to "prove that he was infected with HCV by a Blood transfusion received in Canada during the Class period, notwithstanding the results of the Traceback Procedure." From a Referee's perspective, what is troubling is the issue of how a Claimant could successfully meet the reverse onus imposed by Section 3.04(2) of the Plan text, given the Claimant's lack of access to the donor's private records. That will have to remain an issue for another day, as particularly given the Claimant's focus on the Albumin 25% issue, there was simply no evidence adduced in this case that could allow a Referee to conclude that the Claimant had "refuted the results of the Traceback Procedure." It must be doubly frustrating for the Claimant in that, not only did he establish that he received Albumin 25% during the Class Period, but he was in fact able to establish the threshold requirement that a blood transfusion was received during the Class Period. However, regrettably for the Claimant, he was unable to establish that the packed blood cells so received were infected with the HCV. Therefore, while there is a considerable temptation to wish to assist the Claimant, if the evidence allowed one to do so, in this case, there was simply no evidence adduced that would allow the findings from this process to be disturbed. To the extent that the Claimant still relies on the transfusion of packed cells in support of his appeal, the appeal must also fail.
[24] The Claimant is not entitled to receive compensation. The Administrator has an obligation to assess each claim and determine whether or not the required proof for compensation exists. The Administrator has no discretion to allow compensation where the required proof does not exist. The financial sufficiency of the Fund depends upon the Administrator properly scrutinizing each claim and determining whether the Claimant qualifies. A Referee similarly has no jurisdiction to alter, enlarge or disregard the terms of the Settlement Agreement or Plan, or to extend or modify coverage, whether in connection with the definition of "blood" on the issue of Albumin 25% or the reverse onus contained in Section 3.04(2) of the Plan text.

D. Decision

[25] Upon careful consideration of the Settlement Agreement, Plan, Court orders and the viva voce and documentary evidence tendered, the Administrator's denial of the Claimant's application for compensation is hereby upheld.

Dated at Saskatoon, Saskatchewan, this 5th day of September 2002.


________________________________
DANIEL SHAPIRO, Q.C.
Referee


 

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