Appeals : Arbitrator Decisions : #54 - August 15, 2002

D E C I S I O N

Claim No. 1300323

I. Issue

1. The question before me in this arbitration is whether the Administrator was correct in denying the Claimant's Claim for compensation on the basis that she did not receive transfused Blood within the Class Period from a donor determined to be HCV antibody positive.

II. Background

2. The Claimant submitted an application for compensation as a Primarily-Infected Person under the Transfused HCV Plan (the "Plan") established by the 1986-1990 Hepatitis C Settlement Agreement (the "Settlement Agreement") approved by Order dated October 28, 1999 of the Supreme Court of British Columbia. The terms of the settlement are pan-Canadian and set out in detail the claims process for determining eligibility and proof of eligibility.

3. By letter dated May 10, 2001, the Administrator denied the Claim on the basis that there was no evidence the Claimant was infected for the first time with HCV via Blood transfusion received in Canada during the Class Period.

4. The Claimant requested review of the Administrator's denial of the Claim by way of arbitration.

5. The Claimant through her authorized representative requested an in-person hearing. The in-person hearing was conducted on March 1 and June 14, 2002 in Vancouver.

6. As the arbitrator and trier of fact, I am required to give reasons for my decision. An arbitrator's reasons for decision, like a judge's reasons for judgment, are not intended to be a recitation of all the evidence and submissions tendered during the conduct of the arbitration. I have had the benefit of considerable written and oral evidence and I have had the benefit of able submissions, in writing and orally, from the Claimant's representative and Fund Counsel. I have carefully considered all of the evidence and submissions in arriving at my decision. That I choose to refer or advert to only some of the evidence and the submissions does not mean that I have not considered everything put before me.

III. Facts

7. The Claimant is infected with Hepatitis C. She suffered liver failure and had a liver transplant in October 1994. She testified at the hearing. I found her to be a woman of great honesty and dignity. She has been extremely courageous in dealing with the ravages of a terrible disease.

8. The Claimant received two transfusions in 1988 during the Class Period. Evidence was submitted that the Claimant also received transfusions after the Class Period. The Claimant testified she began feeling ill after 1988.

9. In 1988 the Claimant had back surgery involving an acute lumbar disc which resulted in a discectomy and laminectomy. She was transfused with two units of blood at the time of the back surgery on or about February 29, 1988. There were two donors identified with the Claimant's 1988 transfusions.

10. According to the medical evidence, the Claimant was negative for risk factors associated with HCV. She and her representative maintained that the 1988 blood transfusions were the only possible source of her infection.

11. The Claimant initiated a Traceback procedure in 1998 on her own. During the administration of the Claim, the Administrator also initiated a Traceback which was joined with the Claimant's Traceback.

12. Canadian Blood Services ("CBS") concluded the Traceback under what is referred to as the Litigation Notification Program. The Traceback results were negative for the two donors associated with the transfusions in February of 1988. One donor had been tested for the HCV antibody in April of 1993 as part of the routine screening process when an individual donates blood in Canada. The second donor was tested on January 4, 2001 for the HCV antibody as part of the Traceback Protocol. CBS reported the results of the Traceback to the Administrator in January 2001.

13. Both donors had been tested for the HCV antibody by what is called an optical density test. The Hepatitis C antibody test uses the enzyme imunoassay method, usually abbreviated as EIA or ELISA. Blood may also be tested for the hepatitis C virus itself by a test known as a PCR test. PCR stands for polymerase chain reaction. A PCR test detects the presence of the actual hepatitis C virus in the person's blood. The nucleic acid (RNA) of the virus is detected. It is referred to as the NAT, or nucleic acid test, as well. Since 1999 blood donors have been screened using both the EIA test and the PCR test.

14. The Traceback investigation dealt with the two units of blood given the claimant in 1988, which were referred to as unit numbers 285668 and 229018. I will refer to the first donor as the one associated with unit 285668; I will refer to the second donor as associated with unit 229018. Unit 285668 was described as red cells. Unit 229018 was described as stored plasma. Unlike the case with the first donor where there was an HCV test on file, there was no HCV test on file in connection with the second donor. CBS, following the Traceback Protocol, contacted the donor and the donor gave a sample of blood in January 2001. At the time of the March 1, 2002 hearing, Ms. Lindsay Patterson, employed as the Coordinator, National Lookback/Traceback Program at the Head Office of CBS in Ottawa, testified that she did not know if the sample of blood given by the second donor in January 2001 was still in existence. As a result, I permitted the parties an opportunity to apply to re-open the hearing for the purpose of submitting further evidence concerning the Traceback relating to the second donor. An application was made and further evidence was taken on June 14, 2002.

15. On June 14, 2002 Ms. Patterson testified again as did Ms. Petra Welsh, laboratory manager of the B.C. and Yukon Centre for CBS. Ms. Welsh works at the Vancouver Blood Centre on Oak Street in Vancouver. She testified that the laboratory tested a sample of the second donor's blood for the HCV antibody. The results of the test were submitted to CBS in Ottawa and were recorded on the Traceback file. By standard operating procedures, the sample of blood was tested only by the EIA antibody test and not the PCR test. The sample was destroyed within days of its testing following standard operating procedure. The samples are retained only if they are reactive.

IV. The Plan and the Traceback Protocol

16. The Plan requires the Administrator to determine whether the source of a claimant's infection with HCV was Blood transfused during the Class Period. As contemplated by Article 3.04(1) of the Plan, the Administrator pursued the Traceback Procedure to determine whether that blood was the source of the HCV.

17. In article 1.01 of the Plan the following definitions appear:

"HCV Antibody Test" means a blood test performed in Canada using a commercially available assay acceptable to the Administrator demonstrating that the HCV antibody is present in the blood of a person.
…
"Traceback Procedure" means a targeted search for and investigation of the donor and/or the units of Blood received by a HCV Infected Person.

18. Article 3.04(1) provides:

… 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 of such HCV person …. (emphasis added)

19. To summarize, Article 3.04(2) provides that notwithstanding the results of the Traceback Procedure, a claimant may prove by evidence he or she was infected for the first time with HCV by a Blood transfusion received in Canada during the Class Period.

20. As part of the Settlement Agreement, the courts have approved a Traceback Protocol. An order of the Supreme Court of British Columbia dated October 28, 1999, sets out the court approved investigation procedure. An order of the same court dated August 14, 2000, established the Protocol for Traceback Procedure. By further order dated February 6, 2001, Smith, J. (as he then was) approved an amended Protocol Criteria for Traceback Procedure as set out in the form appended as Schedule 1 to that order. Schedule 1 defines Traceback Procedure as a targeted search which can include a Records Search, a Class Period Search and/or a Pre-Class Period Search. A Records Search is defined to mean "that stage of Traceback Procedure where a search is conducted to match the units of Blood received by an HCV Infected Person at any time against the records of Canadian Blood Services ("CBS") and Hema-Quebec to determine if the HCV antibody status of the donor of some or all of the units received is known." Class Period Search means "that stage of Traceback Procedure where attempts are made to locate the donors of the units of Blood received by an HCV Infected Person during the Class Period and, where necessary, to have the donor tested to determine his or her HCV antibody status." (emphasis added)

21. In this case there was a Records Search for the first donor and a Class Period Search for the second donor.

22. There is nothing in the court-approved Traceback Protocol, directly or indirectly, calling for anything other than the determination of the HCV antibody status of a donor.

23. I have read the court-approved Traceback Protocol with care and I have concluded the Administrator in the case appropriately followed the requisite procedures. A Records Search for the first donor turned up a negative antibody test in 1993. A Class Period Search for the second donor resulted in a negative antibody test in 2001. Accordingly, by the terms of the Protocol, the Administrator was bound to reject the Claim.

24. Paragraph 17 of the Protocol reads as follows:

SECTION 3.04(1) - REJECTION OF CLAIM

17. The Administrator shall, after determining in accordance with the provisions of Section 3.04(1) of the Plan and subparagraph 7(a), 7(d)(i), 8(a), 8(b), 9(a), 9(d)(i), 9(f)(i), 10(a) or 10(d)(i) above that a Claim must be rejected based upon the Traceback Procedure result, advise the claimant that, unless the claimant provides further evidence of first infection ("Further Evidence of First Infection") which establishes to the satisfaction of the Administrator that the person claimed to be the Primarily-Infected Person was infected for the first time with HCV by a Blood transfusion received in Canada during the Class Period notwithstanding the Traceback Procedure result in accordance with section 3.04(2) of the Plan, his or her claim shall be rejected (a "Section 3.04 Letter").


25. The Administrator advised the Claimant by letter dated March 19, 2001 that her Claim for compensation under the Settlement Agreement would be rejected unless she could provide further evidence that she was infected for the first time with HCV by a Blood transfusion received in Canada during the Class Period. The Claimant was advised that all donor searches were complete and the Traceback results showed that the donors or units of blood received in the Class Period were determined to be negative for the HCV virus. Subsequently, the Administrator was not satisfied that there was Further Evidence of First Infection and accordingly the Claim was denied by letter dated May 10, 2001.

26. The Claimant then initiated a request for review of the Administrator's decision by way of arbitration.

V. The Evidence

For the Claimant

27. The Claimant testified as previously indicated. Her evidence spoke volumes of the courage of some people to lead productive lives in the face of great adversity. She is an admirable woman. Unfortunately, on the issue before me, her evidence was of little help.

28. Dr. Fraser Norrie submitted a report dated November 6, 2001 and testified on behalf of the Claimant. Dr. Norrie is a dedicated general practitioner who treats a significant number of patients with HIV/Aids and Hepatitis C. He conceded that he was not as expert on matters relating to HCV as was Dr. Steven Kleinman, who produced a report dated January 14, 2002 and testified on behalf of the Administrator as a pathologist with an expertise in transfusion medicine, blood banking, transfusion transmitted infections and diseases including HCV. I accepted Dr. Norrie as a duly qualified medical expert with a special interest in HIV/Aids and HCV.

29. Dr. Norrie testified that there may be a small cohort of people who are infected with the virus but who do not develop antibodies. He referred to patients in his practice who have Hepatitis C and HIV but test negative for the Hepatitis C antibody. He also referred to a letter dated May 3, 2001 authored by two doctors at the British Columbia Centre for Excellence in HIV/Aids at St. Paul's Hospital in which the doctors identified two patients infected with HIV and Hepatitis C who repeatedly tested negative for the Hepatitis C antibody but tested positive on a PCR test for Hepatitis C. It was Dr. Norrie's opinion that in the case of Tracebacks, the PCR test should be used as well as the antibody test.

30. Dr. Norrie also discussed a cohort of people who may be in the very early stages of the virus but have not developed the antibody. I understand that CBS has screened donors since 1999 using both tests to capture results that may otherwise be missed during that brief window.

31. Dr. Norrie also testified about the time frame between HCV infection and liver failure. He testified that the typical time frame is more in the range of twenty years but it is not impossible for the disease to progress within six years, as would have to be case here if the Claimant was first infected with HCV in 1988.

32. Dr. Norrie also accepted in cross-examination that in approximately 10% of the Hepatitis C cases the source of the infection cannot be found.

33. Although I regarded Dr. Norrie as a conscientious and dedicated physician, I did not find his evidence about PCR testing particularly helpful since the Plan and the Traceback Protocol require only antibody testing for a Traceback Procedure. Additionally, the evidence from Dr. Kleinman offered a rational basis for the use of only the antibody test for Traceback investigations.

For the Administrator

34. As indicated, Dr. Steven Kleinman testified for the Administrator. His professional work falls more in the fields of epidemiology and public health rather than the care of individual patients. He is currently a clinical professor of pathology at the Faculty of Medicine, University of British Columbia and an adjunct scientist to CBS. He has been a consultant to blood collection agencies, hospitals, government and industry. I accepted Dr. Kleinman as an expert on blood related diseases, blood screening, blood collection and Tracebacks.

35. Dr. Kleinman testified about the typical length of time for one to contract advanced liver disease after HCV infection. He said it would be highly unusual for someone to have advanced liver disease in six years but he would not say it could not happen. He testified that statistically it is more likely that a person would have advanced liver disease after twenty years of infection rather than six years. He referred to scientific literature to the effect that only 5% of the people who contract advanced liver disease from HCV do so as early as 10 years from the date of infection. This evidence of Dr. Kleinman raises the significant possibility that the Claimant was infected with the Hepatitis C virus prior to 1986, more likely in the 1970's. Dr. Kleinman also noted that although no other Hepatitis C risk factors had been identified in this case, the US Centre for Disease Control and Prevention states that no risk factor is found in 10% of Hepatitis C cases.

36. Dr. Kleinman further testified that he is medically certain that the donors in this case could not have been in the early window of HCV infection without developing the antibody because they had subsequent negative antibody tests. 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 such 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.

37. 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.

38. Dr. Kleinman further testified that several versions of the Hepatitis C antibody test have been licensed since 1990. Each version has been licensed only after it has been validated to perform reliably.

39. Dr. Kleinman also reviewed the antibody test results in this case and he confirmed the results were clearly negative and interpreted correctly.

40. Dr. Kleinman also testified that the rate of non-immunocompromised donors who are HCV positive and antibody negative is one in 7.7 million. Although there was no screening for HCV in 1988, there was screening for HIV. The two donors in question would not have been infected with HIV.

41. In his report dated January 14, 2002, Dr. Kleinman came to the following conclusions:


1. The possibility that one of the two hepatitis C antibody negative blood donors transmitted hepatitis C to the appellant at the time of their previous blood donations is extremely remote. The literature data indicate that the frequency at which a blood donor would be infectious (i.e. hepatitis C PCR positive) and hepatitis C antibody negative is approximately one in 7.7. million.

2. If the infection were to have occurred from these transfusions given to the appellant in early 1988, the time course from acquisition of hepatitis C infection to liver transplantation would be less than seven years. This is a highly unusual time course. The occurrence of liver failure in 1994 would be more consistent with a date of infection that preceded 1986.

3. Absence of an identifiable source of hepatitis C infection does not by default indicate that hepatitis C was acquired from blood transfusion.


42. Other witnesses for the Administrator included (i) Carol Miller, the appeal coordinator for the Administrator and a registered nurse for more than 20 years; and as mentioned, (ii) Lindsay Patterson, of CBS and (iii) Ms. Petra Welsh, laboratory manager of the Vancouver Blood Centre. The evidence of these three witnesses, taken together, satisfies me that the Administrator and CBS followed the requisite procedures and protocols in the investigation of the Claimant's Traceback into whether or not the donors identified with the transfusion in the Class Period were HCV antibody positive.

VI. Jurisdiction/Authority

43. The role of the Administrator under the Settlement Agreement is to administer the Plan in accordance with its terms. The Administrator has no discretion to allow compensation where the required proof of entitlement does not exist. The Administrator has no authority to alter or ignore the terms of the Plan. As an arbitrator, my jurisdiction is limited as well. I too am bound by the terms of the Settlement Agreement, the Plan and court approved Protocols. I certainly cannot make a decision contrary to them or amend them, even if I thought they were deficient.

44. In a decision by Referee John Sanderson, Q.C., affirmed by Mr. Justice Pitfield of the Supreme Court of British Columbia in the matter of the HCV 1986-1990 Transfused Settlement Agreement Re: Claim No. 1300430, 2002 BCSC 908, the Referee stated as follows:

…The words of Article 3.04(1) of the Plan are clear and unambiguous that the Administrator '… must reject the Claim …' in circumstances such as these. The Administrator must administer the Plan in accordance with its terms. The Administrator does not have the authority to alter or ignore any of the provisions of the Plan. Similarly, a referee [arbitrator] when called upon to review a decision of the Administrator, must apply the relevant provisions of the Plan to the individual circumstances of the Claimant and may not alter or ignore any of its terms.

VII. Analysis

45. At the end of the day, the Claimant's representative was left to argue that in this case the Traceback Procedure was unsatisfactory and unreliable, there was evidence refuting the Traceback result under Article 3.04(2) and that PCR tests should be conducted on samples obtained as part of the Traceback Procedure.

46. I can understand a certain amount of frustration on the part of the Claimant and the Claimant's representative in dealing with administrative bodies that have set rules and standard operating procedures, some of which are not actually available for public scrutiny. In addition, I can understand a certain level of frustration and doubt when the results of Tracebacks and blood tests of donors are provided but without source documents. However, the Plan and Protocols as currently written do not require the production of source documents.

47. In this case I am satisfied that the Administrator followed properly the court approved investigation procedures including the court-ordered Traceback Protocol.

48. I am also satisfied, based on all the evidence, that the Heptatis C antibody test results are valid and reliable.

49. The Traceback Protocol directs the Administrator, as provided in subsection 3.04(1) of the Plan, to reject a claim where the Traceback information shows 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 a HCV antibody positive. The Administrator so rejected the claim in this case. The rejection was subject to the Claimant's right to provide evidence to refute the Traceback Procedure results as provided in Section 3.04(2) of the Plan.

50. I agree with the comments of Arbitrator Wacyk, who decided Ontario Claim No. 1402149 on February16, 2002:

… [Article] 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.

51. In this case there was no probative evidence that the negative HCV antibody test results, obtained as a result of the Records Search of the first donor and the Class Period Search relating to the second donor, were invalid or unreliable. The absence of PCR tests is irrelevant given the wording of the Plan and the Traceback Protocol.

52. Additionally, the scientific evidence does not support the Claimant's assertion that she must have been infected for the first time by the blood transfusions in 1988. As Dr. Kleinman wrote in his report dated January 14, 2002:

Blood donors are presumably not immunocompromised, given that they have successfully completed the blood donor interview and have tested HIV negative. These hepatitis C testing findings in blood donors indicate that, while it is possible for an individual with a presumably normal immune system to test hepatitis C PCR positive, hepatitis C antibody negative beyond the expected 2 to 3 month interval, it is an exceedingly rare finding (estimated to occur at a rate of 1 in 7.7 million tested donations from the published American Red Cross data).

53. There is also the evidence from Dr. Kleinman, accepted by Dr. Norrie, that in 10% of cases of Hepatitis C the source of infection cannot be identified.

54. Further, both experts testified that the date of liver failure indicates the Claimant's infection typically would have occurred much earlier than 1988, although neither could completely rule out the possibility of a later infection.

55. In my view, having considered all of the evidence, the Claimant falls far short of showing on a balance of probabilities that she was infected for the first time with HCV by a Blood transfusion in Canada during the Class Period. On the facts of this case, I must find that the Administrator correctly determined that the Claimant is not entitled to compensation pursuant to the Settlement Agreement.

56. I uphold the Administrator's denial of the Claimant's request for compensation.

Dated at Vancouver, the 15th day of August, 2002.

____________________________
Vincent R.K. Orchard,
Arbitrator