Appeals : Confirmed Referee Decisions : #71 - December 27th, 2002

D E C I S I O N

Background:

1. The Claimant submitted an application for compensation as a Primarily Infected Person under the Transfused HCV Plan ("the Plan"), as set out under the terms of the 1986-1990 Hepatitis C Settlement Agreement ("the Settlement Agreement").

2. By letter dated June 14, 2002, the Administrator denied her claim on the basis that the Claimant did not provide sufficient evidence to support her claim that she was first infected with HCV by a blood transfusion received in Canada during the period from January 1, 1986 - July 1, 1990 ("the Class Period").

3. The Claimant requested that a Referee review the decision of the Administrator in an in-person hearing.

Evidence:

4. It is not disputed that the Claimant is infected with Hepatitis C, or that she received three units of blood on January 2, 1987 at the Oshawa General Hospital as a result of a hysterectomy.

5. Nor is it disputed that the traceback report of these three transfusions showed that the HCV status of the donors was negative.

The Administrator:

6. It was agreed that the Administrator would proceed first.

7. Ms. Carol Miller, the Appeal Co-ordinator for the Administrator, and a registered nurse for more than 20 years, maintained that the testing method used to conduct the trackback in this instance, know as the ELISA (Enzyme-linked immunosorbent assy) is the most accurate - with a 99% accuracy rate.

8. Ms. Miller submitted that while approximately 20% of individuals who contract Hep C will completely resolve their infections after the acute stage, the antibody usually remains life-long. The ELISA method tests for these antibodies rather than the virus (HCV)

9. In support of this assertion, Ms. Horkins, Counsel for the Administrator, referred to the evidence of Dr. Kleinman, as set out in Arbitrator Orchard's decision regarding Claim # 1300323. In that case, Arbitrator Orchard accepted Dr. Kleinman as an expert on blood related diseases, blood screening, blood collection and tracebacks. Dr. Kleinman's evidence was that studies show that 20 - 45% of persons known to have been infected with HCV will test positive for the antibodies but negative for the virus at approximately 17 - 23 years after the initial infection.

10. Ms. Horkins further advised that for about 20% of those who contract HCV, the source is unknown.

11. However, Ms. Horkins also pointed out that the Claimant had three tattoos applied during 1979 - 80, and that tattoos are a risk factor for infection with HCV.

The Claimant:

12. The Claimant testified that she felt very ill after the hysterectomy for which she received the transfusions and developed a high fever on the fourth day following the surgery - which she submits suggests the onset of the HCV infection. The Claimant advised that she had a partial hysterectomy two years prior and did not experience any fever.

13. According to the Claimant, she has never fully recovered following her surgery and has become increasingly debilitated by her infection with HCV.

14. The Claimant's husband and sister-in-law both described the change they have observed in the Claimant's physical condition. They described her as "high energy" and very active prior to the operation and transfusion, and subsequently much less so. e.g. tiring easily, requiring time to rest etc.

15. While the Claimant conceded she had three tattoos, she maintained they were received from a "clean" facility.

Argument:

The Administrator:

16. Ms. Horkins argued that although the Claimant received a blood transfusion during the Class Period, the negative result of the traceback procedure has established, on a balance of probabilities, that the transfusion was not the source of the Claimant's infection.

17. Consequently, Ms. Horkins argued that both the Administrator, and I as the Referee, are required to reject her claim.

18. However, Ms. Horkins also noted that subsection 3.04(2) of the plan provides that notwithstanding the results of the Traceback Procedure, a claimant may prove he or she was infected for the first time with HCV by a Blood Transfusion received in Canada during the Class Period. However, Ms. Horkins argued that to meet such a test would require compelling evidence, such as a physician who was prepared to support the Claimant's assertions.

The Claimant:

19. The Claimant maintained the blood transfusion must have been the source of her infection.

20. The Claimant took issue with the traceback report issued, which simply lists the unit number of the blood transfused, the product name, the date of the transfusion, the testing generation, and the HCV status of the Donors as negative. The most recent test dates for the donors were shown to be: 2000-07-24; 2000-05-29; and 1997-11-20.

21. The Claimant argued that she should get the actual test results as anyone could type up the report. She also argued that the report was further suspect because she received it two weeks after it was requested, although she had been told it might take up to one year.

22. Furthermore, she argued that because the Agency which now conducts the testing, the "Canadian Blood Services" ("CBS") is related to the Red Cross, which is responsible for the initial transfusions, any information provided is suspect.

23. In fact, in the Claimant's case, two of the tests had been administered by CBS, and one had been administered by the Red Cross.

24. The Claimant indicated she would like the donors to be retested.

25. Finally, the Claimant indicated she would be satisfied for me to make my decision on the basis of the evidence and argument I had heard at the hearing.

26. In reply, Counsel for the Administrator responded that with regard to the appropriateness of the traceback being conducted by CBS or the Red Cross, the Administrator relied on the decision of The Honourable Mr. Justice Pitfield. His decision was an appeal of a decision of John P. Sanderson, Q.C., Referee, dated February, 6, 2002.

27. In that instance, the traceback investigation was commenced by the Canadian Red Cross but completed by Canadian Blood Services.

28. Mr. Justice Pitfield held as follows:
In my opinion, when asked by the Administrator to carry out a traceback Canadian Blood Services is entitled to rely upon information, screening processes and results obtained by the Canadian Red Cross Society in the course of a traceback provided Canadian Blood Services satisfies itself that the steps taken in relation to the process prior to the receipt of a request from the Administrator for the conduct of a traceback procedure, comply with accepted scientific and clinical standards so as to be reliable. Canadian Blood Services is not obliged to repeat that which was done in relation to the Claimant's transfusion unless Canadian Blood Services identifies a deficiency in the process.

29. Ms. Horkins pointed out that the decision confirms the acceptability of the trace back tests being conducted by either the Red Cross or CBS.

30. Ms. Horkins also indicated that the relatively fast response may be because the donors were subjected to what is now routine testing when they returned to give blood. Consequently, the results would have been on record.

Post-hearing:

31. Following the hearing, I received a message on my voice mail from the Claimant. In that message, she reiterated her mistrust in the testing process. As no new issues were raised, nor evidence submitted, I took no further steps regarding this message.

Analysis:

32. As part of the Settlement Agreement, the Administrator is required to conduct a traceback in respect of the units of blood transfused, to determine whether that blood was the source of the Hepatitis C Virus. The traceback procedure ("the Traceback Protocol") has been approved by the Ontario Court (General Division) .

33. Subsection 7(a) of the Traceback Protocol directs the Administrator, as provided in subsection 3.04 (1) of the Plan, to reject a claim where Traceback Procedure information, and the results of any records search show that all of the donors of the Blood received by a person claiming to be a Primarily-Infected Person during the Class Period are determined not to be HCV antibody positive. This rejection is subject to a claimant's right to provide evidence to refute the Traceback Procedure result as provided in Section 3.04(2) of the Plan.

34. Subsection 3.04 (1) provides that 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 or antibody positive, subject to Subsection 3.04(2), the Administrator must reject that person's Claim.

35. While I understand the Claimant's concerns regarding the method and source of the traceback procedure, it has been agreed to by the signatories to the Settlement Agreement and endorsed by the Court. Consequently, even if I were to share the Claimant's concerns, which I do not, I have no authority to order another process for traceback testing.

36. However, as pointed out by Ms. Horkins, subsection 3.04(2) provides that notwithstanding the results of the Traceback Procedure, a claimant may prove he or she was infected for the first time with HCV by a Blood Transfusion received in Canada during the Class Period.

37. In this instance, the only evidence to counter the negative traceback results is the evidence of the Claimant's fever and diminished energy following her operation and transfusion, as described by herself and her relatives. However, without compelling medical evidence to overcome what is essentially a presumption of non-infection resulting from the negative traceback results, I am unable to find that the Claimant was infected with HCV as a result of the blood transfusions she received.

38. Consequently, I find there is insufficient evidence to prove the Claimant was infected, for the first time, with HCV by a Blood Transfusion received in Canada during the Class Period.

39. Nor do the Administrator or I, as a Referee, have discretion to grant compensation to individuals infected with Hepatitis C who cannot show they come within the parameters of the Settlement Agreement.

40. Accordingly, I find the Administrator correctly determined that the Claimant is not entitled to compensation pursuant to the Settlement Agreement as she has not demonstrated that she was infected for the first time with HCV by a Blood Transfusion received in Canada during the Class Period.

Determination:

41. The decision of the Administrator to deny the Claimant compensation pursuant to the Hepatitis C 1986-1990 Class Action Settlement is upheld.

DATED AT TORONTO, THIS 27th DAY OF DECEMBER, 2002.

Tanja Wacyk, Referee