Appeals : Arbitrator Decisions : #40 - February 16, 2002

D E C I S I O N

1. 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 May 10, 2001, the Administrator denied his claim on the basis that the Claimant did not provide sufficient evidence to support his claim that he 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 an Arbitrator review the decision of the Administrator in an in-person hearing.
      
      
2. Evidence:
   
   It was agreed that Counsel for the Administrator would proceed first.
   
   
   4. The following was not in dispute:
      
      
      • The Claimant is infected with Hepatitis C.
        
      • The Claimant received two units of blood on March 22, 1990, at Branson Hospital in North York, Ontario.
        
      • Neither the donors nor the blood was tested at the time of the transfusion.
        
        
   5. The Claimant testified that he has never engaged in any activities which might have resulted in his having been infected with Hepatitis C. He maintained that the blood transfusion was the only possible source of his having been infected.
      
      
   6. At the first day of hearing the Claimant produced a brochure published by the Canadian Liver Foundation titled "hepatitis C; MEDICAL INFORMATION UPDATE." The brochure states at page 5, that 15% to 25% of patients will completely resolve their infections after the acute stage.
      
      
   7. The Claimant maintained it was possible the donors of the two units received by him were within that group of 15% to 25%, and that their infection had cleared by the time they were tested.
      
      
   8. The hearing was adjourned to enable both parties to further explore this possibility.
      
      
   9. On the second day of hearing the parties filed documents dealing with the time period within which Hepatitis C infections, as well as the accompanying antibodies, could clear. The documents were inconsistent with regard to the time required for clearing of the antibodies.
      
      
   10. The Administrator relied on a letter dated August 8, 2001, from Dr. Frank Anderson, Department of Gastroenterology, to Mr. William Ferguson, Fund Counsel in British Columbia.
       
       
   11. In his letter, Dr. Anderson indicates he is responding to a request for clarification regarding testing for Hepatitis C and the possibility of spontaneous clearance of the virus and the antibody.
       
       
   12. Dr. Anderson notes that the serology for Hepatitis C is of two types. The first tests for the virus (HCV RNA) using a method called PCR (polymerase chain reaction). The second test is for antibodies, and is done by one of two methods, ELISA (Enzyme-linked immunosorbent assy) or RIBA (Recombinant immunoblot assay).
       
       
   13. Dr. Anderson indicates that once infected, about 20% of persons may clear the virus spontaneously - but usually do so within six months of infection and not thereafter. He further states that in those circumstances the antibody usually remains life-long. In those few cases where patients lose the antibody, this occurs twenty years after the initial infection.
       
       
   14. With regard to the "Risk of Transmission" Dr. Anderson writes:
       
       The likelihood of a person initially testing positive for HCV RNA (PCR) and positive ANTI-HCV (ELISA or RIBA) and subsequently spontaneously clearing the HCV RNA and then losing antibodies (ELISA, RIBA) is extremely rare. To do so in less than twenty years would not seem possible.
       
       The possibility of a person contracting hepatitis C from blood products from an infected donor, and the donor testing negative for hepatitis C at a later date is very unlikely but there are a few requisites. If the donor has been tested for HCV RNA (PCR) and is now negative, the donor would have to have donated blood within a 6 month period after their own infection and before their own clearance. If the donor has been tested for anti HCV (ELISA or RIBA) one would need to know which generation test. There is a small chance that the donor may have lost detectable antibody [sic] but reports in the literature suggest that this would only occur after 20 years of infection. If the donor has tested negative with both the PCR and ELISA or RIBA the likelihood of him/her having had hepatitis C at the time of donation is extremely rare. In other words, the donor would have to have donated during the 6 months window, he would have had to then be one of the 20% who spontaneously clear the virus, and then one of the very few who lose the antibody after 20 years. The likelihood of all these events is extremely unlikely. The time period of the Class Action suite [sic] 1986-1990, would make spontaneous loss of antibody unlikely since it is not yet 20 years after the earliest possible time of infection, 1986. If the donor was tested for Anti-HCV only, there is a small chance that he has lost antibody, [sic] but only after 20 years and he would have had to be HCV RNA positive at the time of his donation. If he or the donated blood were able to be tested for HCV RNA and were positive, then he could have been the source of infection, but if the HCV RNA is negative, as outlined above, it is extremely unlikely that he was the source of infection.
       
       
   15. The Claimant relied on the following excerpt from the Journal of Hepatology 1990, (Nov.):
       
       Long-term persistence of hepatitis C virus antibodies in a single source outbreak.
       Dittmann S, Roggendorf M. Durkop J, Wiese M, Lorbeer B, Deinhardt F. Central Institute of Hygiene, Microbiology, and Epiderniologie, Berlin, Federal Republic of Germany.
       
       The occurrence of antibodies to hepatitis C virus (HCV) was investigated in 81 patients who developed hepatitis non-A, non-B (HNANB) after parenteral administration of contaminated immunoglobulin to prevent Rh sensitization. Sera from 74 of the 81 patients (89.9%) were anti- HCV positive at either 6-12 months or 9-10 years after administration of immunoglobulin. Sera were not available from any patients at either of the times: however, 52 of 56 sera (92.9%) were anti-HCV positive 6-12 months after use of immunoglobulin, and anti-HCV was present in 45 of 65 sera (69.2%) 9-10 years after immunoglobulin treatment. Of the latter, only two of 13 (15.4%) sera from patients who recovered from hepatitis were anti-HCV positive, whereas 43 of 52 patients (82.7%) with chronic disease were anti-HCV positive. The ELISA using a recombinant antigen was found a good detector as marker for a HCV infection because 90% of patients infected by a common source became anti-HCV positive. However, 10 years after infection most patients who did not develop chronic disease no longer had detectable antibodies. [emphasis mine]
       
       
   16. The hearing was again adjourned to allow further clarification by the parties regarding the loss of antibodies.
       
       
   17. Written submissions, were subsequently received from Counsel for the Administrator. The submissions indicated that further investigations on behalf of the Administrator resulted in the following information being provided by the Canadian Blood Services:
       
       
       • One of the donors whose blood was received by the Claimant made in excess of 40 donations
         
       • The other donor, whose blood the Claimant received, made more than 90 donations.
         
       • Testing was implemented for hepatitis C antibody (anti-HCV) by July 1990.
         
       • One of the donors tested negative for anti-HCV in November, 1990 and the other tested negative in July 1990 and December 1990.
         
       • Since testing was implemented, one of the donors has been tested for anti-HCV eleven times, and the other donor has been tested for anti-HCV forty times.
         
       • Neither of the donors have had a reactive test for anti-HCV.
         
         
3. Argument:
   
   Final submissions were made via teleconference.
   
   
   18. Counsel for the Administrator argued that it is highly unlikely the donors were infected at the time they donated the blood received by the Claimant.
       
       
   19. In the first instance, this would mean they would have had to donate the blood during the six months during which they were infected and subsequently cleared the virus. They would then have had to clear the anitibodies by no later than July and November of 1990, when they tested negative. Counsel pointed out that this was only months following the Claimant having received his transfusion.
       
       
   20. Furthermore, Counsel for the Administrator pointed out that the current scientific information is that a minimum of ten to twenty years is required for the antibodies to clear. In the Claimant's case, it means the donors would have had to donate the blood at least ten years prior to when it was transfused to the Claimant. Counsel for the Administrator argued that this is highly unlikely, and there was no evidence to suggest this was the case.
       
       
   21. Rather, Counsel for the Administrator suggested the Claimant may simply be part of the 15% of persons infected for which the source of the infection is not known.
       
       
   22. The Claimant pointed out that the scientific knowledge regarding Hepatis C is evolving. He argued that both the ten and twenty year time frames for the loss of antibodies were speculative and that the discrepancy between them demonstrated the lack of firm data on that issue.
       
       
   23. The Claimant argued that in light of the lack of certainty with regard to the time required for the antibodies to clear, it was possible they could, in some instances, clear more quickly.
       
       
   24. The Claimant suggested this occurred in his case, as there were no other circumstances under which he could have been infected.
       
       
   25. Counsel for the Administrator responded that while the existing scientific information is inexact, we must take it as we find it, as that is the best evidence available at this time.
       
       
4. Analysis:
   
   
   26. 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) 1.
       
       
   27. 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.
       
       
   28. 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.
       
       
   29. 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.
       
       
   30. In my view, subsection 3.04(2) requires evidence that is specific to a particular claimant, and that proves, on a balance of probabilities, that that claimant was infected for the first time with HCV by a Blood Transfusion received in Canada during the Class Period.
       
       
   31. In this case, the evidence shows that in some rare instances, a minority of individuals who spontaneously clear the Hepatitis C virus also clear the antibodies. The scientific information placed before me suggests the time required for an infected individual to clear detectable antibodies is somewhere between ten to twenty years.
       
       
   32. In order to succeed, the Claimant would have to show that at least one of the donors was one of the 20% who spontaneously clear the virus - but that before doing so, donated the blood received by the Claimant within the six month window the donor was both infected and cleared the virus.
       
       
   33. Finally, the Claimant would have to show that the blood he received from that donor was donated sometime between ten and twenty years prior to the donor testing negative for anti-bodies. As this testing occurred only months after the transfusion, this would mean the blood received by the Claimant would have to have been donated approximately ten to twenty years prior to the time of transfusion.
       
       
   34. However, there is no evidence of any of the above.
       
       
   35. 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.
       
       
   36. In arriving at that conclusion, I acknowledge the scientific information and understanding in this area is less than precise, and continues to evolve. However, even if I were to find that it was possible the required time period for clearing antibodies is less than ten years, as I was urged to do by the Claimant, without specific evidence that this occurred in the Claimant's case, such a finding would not assist the Claimant A theoretical or scientific possibility does not result in a probability so as to satisfy the Claimant's burden of proof.
       
       
   37. To find otherwise, would essentially render the Traceback Procedure meaningless.
       
       
   38. Nor do the Administrator or I, as an Arbitrator, have discretion to grant compensation to individuals infected with Hepatitis C who cannot show they come within the parameters of the Settlement Agreement.
       
       
   39. Accordingly, I find the Administrator correctly determined that the Claimant is not entitled to compensation pursuant to the Settlement Agreement as he has not demonstrated that he was infected for the first time with HCV by a Blood Transfusion received in Canada during the Class Period.
       
       
5. Determination:
   
   
   39. 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 16TH DAY OF FEBRUARY, 2002.

Tanja Wacyk, Arbitrator