Appeals : Arbitrator Decisions : #128 - March 11, 2004

D E C I S I O N

Claim ID: 1300539

I. ISSUE

1. The threshold issue in this arbitration is whether the Administrator was correct in denying a claim under the Transfused HCV Plan (the "Plan") on the basis that the Claimant did not receive transfused Blood within the Class Period from a donor determined to be HCV antibody positive. The answer to that question turns on whether there is "persuasive evidence" under section 3.04 (2) of the Plan, to the effect that the Claimant was infected for the first time with HCV by a Blood transfusion received in Canada during the Class Period, which refutes the results of a negative traceback under section 3.04(1) requiring the Administrator to reject the claim.

II. BACKGROUND

2. The Claimant submitted an application for compensation as a Primarily-Infected Person under the Plan approved by various superior court orders in Canada. The claim was initiated in October 2000.

3. The claim was founded on facts that are not in dispute:

4. The Administrator initiated a traceback under the Litigation Notification Program ("LNP") on January 15, 2001. The LNP is an internal program of Canadian Blood Services ("CBS") by which CBS conducts tracebacks on an expedited basis in accordance with the court approved Traceback Protocols.

5. In the case of the Claimant, a traceback had already been initiated in 1998 under Health Canada Guidelines.

6. The Court process by which CBS conducts a traceback investigation is the same whether the case is an LNP case or not; however, the LNP requires completion of a traceback investigation within six months of the Fund Administrator's request and there is separate funding for the LNP. The LNP traceback joined the traceback already initiated.

7. By letter dated April 4, 2001, the LNP traceback was completed and the results concerning the four donors of the four units of blood transfused to the Claimant in February 1988 were all negative.

8. By letter dated July 6, 2001, the Administrator rejected the claim on the basis of the negative traceback subject to the provision of further evidence to the contrary; i.e. that notwithstanding the results of the Traceback Procedure the Claimant was infected, for the first time, with HCV during the Class Period. However, the Claimant had died in May 2001 of causes unrelated to HCV.

9. The Claimant's son, her personal representative, proceeded with the Claim.

10. In processing the Claim, the Administrator requested further information from CBS. As a result, CBS issued a detailed letter dated August 15, 2002 discussing the results of the traceback.

11. By letter dated September 24, 2002 the Administrator issued its final denial of the claim.

12. A review of the Administrator's denial of the claim is sought by way of arbitration.

13. After a number of pre-hearing conferences resulting in certain directions and a preliminary order, an in-person hearing was conducted on February 18, 2004 in Vancouver, B.C.

III. THE EVIDENCE AND SUBMISSION

14. The plaintiff's adult son appeared at the hearing as both the Claimant's personal representative and as a witness. Mr. William Ferguson appeared as Fund Counsel. The parties agreed on a number of evidentiary points although they did not agree on the inferences to be drawn from the evidence nor on the conclusion I should reach about the evidence.

15. It was certainly not in dispute that the Claimant had been exposed to the Hepatitis C virus and tested positive commencing in 1995 for HCV antibody. It was also agreed that the Claimant was transfused during the Class Period and there was no evidence that she received blood products before or after the Class Period. Fund Counsel agreed that the basic pre-conditions for entitlement to compensation under the Plan were met: proof by appropriate records of a Blood transfusion in Canada during the Class Period and positive HCV antibody tests.

16. It was also clear from the evidence (and not disputed by Fund Counsel) that the Claimant, born in 1920, lead a long life without known risks of exposure to lifestyle risks of Hepatitis C such as those noted above.

17. It is also common ground that the Claimant during her lifetime did not have any symptoms of the HCV virus and she died of causes unrelated to Hepatitis C. The evidence also revealed that she had a history of numerous health complaints which resulted in a number of medical procedures and surgeries before and after her colon surgery in February 1988. Parts of her medical charts were put in evidence but the parties did not have her entire medical records.

18. It is apparent that it will never be known with any medical certainty when the Claimant was exposed to the Hepatitis C virus. All that can be said with certainty is that the Claimant, according to a laboratory report in the records of the Claimant's family physician, tested positive for the HCV antibody in April 1995 and therefore, according to the testimony of Dr. Kleinman, an expert in transfusion medicine, the Claimant was exposed to HCV at some point during her lifetime up to a few months before April 1995. Dr. Kleinman concedes that on the basis of the medical records available for his review, he would implicate the February 1988 transfusion as the likely source of the Claimant's infection but for the negative traceback.

19. The medical records, albeit incomplete, provided evidence that before the Claimant's colon cancer surgery in 1988, she had a number of previous operations.

20. The records of UBC Hospital in February 1988, subsequently confirmed by entries in Dr. Belton's chart, show that the Claimant had prior surgery including a hysterectomy, removal of her gallbladder and an appendectomy. Following her surgery for colon cancer in February 1988 she also had a right mastectomy and procedures for hernia repair. Fund Counsel also notes a procedure called a sigmoidoscopy, involving an internal probe, conducted on February 9, 1988, a procedure obviously connected with the Claimant's colon cancer. Mr. Ferguson suggests that the cause of the Claimant's HCV infection is unknown or is likely linked to other medical procedures which would involve surgeries, scopes, tests, injections, etc. Mr. Ferguson obtained some support for his submission from Dr. Kleinman who gives examples of cases in the United States and Canada of patients acquiring Hepatitis C in the medical clinic setting from improper use of needles to administer intravenous medications, in dialysis units and from infected surgical team members. Dr. Kleinman conceded that there is no actual proof in this case that the Claimant acquired Hepatitis C infection through medical procedures: it is a possible additional route of infection transmission that has not been well documented until very recently. Dr. Kleinman concludes that the cause of the Claimant's Hepatitis C infection in this case is simply unknown.

21. On behalf of the Claimant, considerable reliance was placed on the evidence of two doctors who treated the Claimant in the later stages of her life: Dr. Belton, her general practitioner since 1993 and Dr. Atkinson, a gastroentorologist who treated the Claimant from September 2000 to May 2001. Neither doctor was called as a witness at the in-person hearing.

22. It was Dr. Atkinson's opinion by way of letter dated October 24, 2003 that the Claimant had no risk factors for Hepatitis C and she was not involved in any high risk behaviour. He stated that her only risk factor would have been the 1988 Blood transfusion.

23. Dr. Belton supported the claim initially made in 2000 and he completed a TRAN 2 Form in June 2000. Dr. Belton authored two letters dated October 29, 2003 and January 25, 2004 for specific use in this arbitration. It is Dr. Belton's opinion that the most likely source of the Claimant's Hepatitis C infection was the Blood transfusion in 1988. In his opinion, the Claimant did not have any other risk factors for contracting the virus. As he stated she did not receive dialysis, she did not have an infected spouse, she was never incarcerated in prison, she did not take intravenous nor intra-nasal drugs, she did not have any body piercings or tattoos and she was in a faithful monogamous relationship with a spouse who was free of the Hep C virus. Dr. Belton acknowledged that she did have other operations which potentially could have been a source of exposure to the virus; but, he thought it more likely that she would have contracted the virus from a transfusion rather than an infected surgeon or a contaminated surgical instrument. I believe Dr. Kleinman would agree with Dr. Belton absent the negative traceback which, in his opinion, effectively ruled out the 1988 Blood transfusion as the source of infection.

24. Carol Miller, the Appeal Coordinator for the Administrator, testified. She reviewed the claim file and assisted in the interpretation of some of the medical information. She confirmed that the Claimant received a total of four units of packed blood cells at UBC Hospital in February 1988: two units on February 15, 1988 by way of transfusion pre-surgery and two units on February 19, 1988 post-surgery. Those facts are confirmed in the records and are not in dispute.

25. Ms. Miller assisted with a review of the detailed CBS letter dated August 15, 2002 setting out the results of the traceback procedure. The first donor (Unit A(1)239101) had made 20 blood donations, the last tested in April 1999. The second donor (Unit A(7)239123) also made 20 blood donations with the last donation in March 2000. A third donor (Unit A(8)229776) donated blood on seven occasions with the most recent being in June 1994. The fourth donor (Unit A(4)234426) made only one donation subsequent to the 1988 donation and that donation was in March 2001. The record does not reveal the exact date of all the subsequent donations, save and except the last donor who had only one subsequent test. However, the traceback confirms that all tests were negative for the HCV antibody.

26. Dr. Kleinman submitted a report dated December 30, 2003 and testified. He is a pathologist and an expert in blood transfusions, blood related diseases, blood screening, blood collection and traceback procedures. He gave rather detailed evidence on cross-examination concerning the process for collecting blood and manufacturing blood products. The process is a closed system under rigid sterile controls. He admitted that he is aware of cases of bacterial infection in the bags provided by suppliers but that phenomenon is very rare. He also admitted that, as the processes involve people, there could be failure from human error.

27. Dr. Kleinman also gave evidence about four theoretical reasons why Hepatitis C and HIV viruses could be transmitted by blood transfusion despite testing the blood donors for antibodies to these viruses. The first reason is that a donation might be given prior to the development of the antibody (this is referred to as "window period"). He would effectively rule that out as a possibility in this case as the four donors were all negative for the antibody several years later, and in the case of three of the donors on multiple occasions. A second theoretical reason for transmission is the existence of viral mutations that are not detected by the antibody test. He admitted that this may occur for HIV infection but is not the case for Hepatitis C: all known Hepatitis C viral strains are detected by the EIA 2.0 or 3.0 tests, the tests administered on the donors in this case. A third reason is the existence of an immunosilent carrier state, in which individuals with normal immune systems do not make Hepatitis C antibody despite having Hepatitis C virus in their blood. This is a very rare phenomenon. As I understood Dr. Kleinman's evidence, this phenomenon is so rare that in four years of screening there have only been three cases out of eight million donors screened in the United States and no cases at all in Canada in screening over four million donations in Canada. A fourth reason for transmission is a laboratory error in performing the Hepatitis C antibody test. Studies have indicated errors at a rate of approximately one to three per 2,000. However, Dr. Kleinman states that an error in testing is extremely unlikely since in three of the four cases, the donors were tested on multiple occasions with consistently negative results. That would leave the fourth donor who was only tested one subsequent occasion in 2001, however by 2001 the screening tests also included the RNA test, a test for the virus. Yet there was no evidence of the actual RNA test in the record. I am therefore left with a potential error rate with respect to the fourth donor of one to three per 2,000 for the antibody test.

28. Dr. Kleinman also gave evidence of a fifth theoretical reason why viruses could still be transmitted by blood transfusion despite testing blood donors for antibodies. He referred to a phenomenon known as seroreversion. That is a phenomenon when someone who is positive at one time for the antibody loses the antibodies in their system. Apparently there has not been much study of the phenomenon. The studies that exist are based on a time frame of 17 to 20 years after exposure. Apparently 7-15% of people exposed to the virus will clear the antibody. People first lose the virus and then the antibody. Two-thirds of people who get the virus never lose it and if one has the virus one will have the antibody. All Dr. Kleinman can say about people losing the antibody at say 6-12 years, is that it has not really been documented but would be an even smaller percentage. Moreover, Dr. Kleinman testified that if one donor lost the antibody that person could only have been infectious for approximately one year before February 1988. If a person loses the virus it will happen quickly and usually within approximately one year. Dr. Kleinman said one would be looking for a very small group, one that had been recently infected before February 1988 but then quickly lost the virus.

29. Dr. Kleinman testified that he is unaware of studies of any people who experienced seroreversion in 13 years. Apparently there are no studies. He referred to 13 years in connection with the fourth donor who was tested again in 2001, 13 years after 1988.

30. In conclusion, Dr. Kleinman agreed he could not rule out seroreversion completely because to be certain one would have had to test the 1988 samples and of course they were never tested. He could only say that it would be very unlikely in this case.

31. Questions were put to Dr. Kleinman concerning an article he coauthored in 1997 in "Transfusion Medicine Reviews" referred to in Referee decision #93, April 16, 2003. Dr. Kleinman stated that part of the article quoted in the decision was not specific to HCV virus but rather generally dealt with viral agents. The third reason discussed in that quotation for reasons why transmission of viral agents might occur, despite testing of blood for evidence of infection, is not applicable specifically to the Hepatitis C virus. This is referred to as the second theoretical reason in his report of December 30, 2003 in this case and in which he says that all known Hepatitis C viral strains are detected by EIA 2.0 or 3.0 tests. The other three potential reasons discussed in the 1997 article apply to HCV and were specifically the window period, the immunosilent carrier and laboratory error, all of which was the subject of evidence in this case.

32. An interesting element of decision #93, not present in this case, is that decision #93 involved a hospitalized patient undergoing surgery who had acute symptoms of HCV infection within a very short time, apparently a month or so from transfusion.

IV. DISCUSSION

33. I am guided by the judicial decision of Mr. Justice Pitfield of the British Columbia Supreme Court pronounced May 9, 2003 in decision #53 in reaching my decision. A number of other decisions including decisions numbered 68, 54, 86 and 110 have been referred to in submissions.

34. In decision #53, Mr. Justice Pitfield stated as follows:

35. A Primarily-Infected Person, as noted by Justice Pitfield, is prima facie ineligible for compensation if the traceback demonstrates that none of the donors of class period transfusions tested positive for the Hepatitis C antibody. Under Article 3.04(1), the Administrator is left no discretion in the face of a negative traceback: the claim must be rejected. Section 3.04(2) allows a claimant a last chance of eligibility if evidence can be mustered to refute the results of the traceback. As Mr. Justice Pitfield articulated, Article 3.04(2) does not permit a claimant to conduct his or her own traceback procedure. It contemplates that there might be evidence which would establish that the source of the infection, more likely than not or on a balance of probabilities, was a transfusion received in the Class Period. According to Mr. Justice Pitfield, contradictory objective evidence would have to be very persuasive if the traceback result is to be refuted.

36. The question I then pose to myself is as follows: am I satisfied, on a balance of probabilities, by persuasive evidence that the Claimant, notwithstanding the traceback, was infected by transfusion in February, 1988 at UBC Hospital? On behalf of the Claimant, reliance is placed on the evidence of Dr. Belton and Dr. Atkinson, the exemplary lifestyle of the Claimant and the possibilities of transmission of the Hepatitis C virus by blood transfusion despite negative antibody tests by the blood donors. Is that evidence sufficiently persuasive to meet the onus of proof? I do not find it sufficiently persuasive.

37. While the evidence of Dr. Belton and Dr. Atkinson was helpful, they did not deal specifically in their letters with the negative traceback nor did they rebut in any way the evidence of Dr. Kleinman. Moreover, while there was convincing evidence of the Claimant's exemplary lifestyle, the evidence of her medical history did not exclude the absence of opportunity to be infected through other medical procedures as noted in paragraph 20 of this decision. Concerning the evidence of Dr. Kleinman, the best that might be said on behalf of the Claimant is the possibility of the phenomenon known as seroreversion or a potential error in the testing of the fourth donor in 2001. I accept the evidence of Dr. Kleinman that the possibility of seroreversion is very unlikely in this case. A possible statistical error rate of one to three per 2,000 in relation to the fourth donor is not, in my opinion, persuasive enough to refute the traceback results. Having considered all the evidence carefully, I conclude that the Claimant has not met the onus of proof required under Section 3.04(2) of the Plan to refute the negative traceback. Accordingly, I uphold the Administrator's denial of the claim.

DATED at Vancouver, British Columbia, this 11th day of March, 2004.

___"Vincent R.K. Orchard_______
Vincent R.K. Orchard, Arbitrator