Appeals : Confirmed Referee Decisions : #79 - January 14, 2003

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] By letter dated May 10, 2001, the Administrator denied the Claim on the basis that, although the Claimant clearly received blood during the period from January 1, 1986 - July 1, 1990 ("the Class Period"), all donor searches were complete and determined that none of the donors or units of blood received by the Claimant tested positive for the HCV virus. The Claimant was provided with 30 days within which to tender further evidence to refute the "negative" Traceback result, in default of which her claim would be rejected.

[3] By way of Notice of Appeal dated May 28, 2001, the Claimant requested that a Referee review the denial of her claim by the Administrator. In paragraph 4 of her Notice of Appeal, the Claimant stated that she wished to review the Administrator's decision for the following reasons:
The Claimant lives a wholesome life-style, one not conducive to exposure to Hepatitis C infection. Also, she is unaware of any contact with anyone with Hepatitis C. The blood transfusion she received is the only conceivable chance of exposure.

[4] The Claimant checked off the box in paragraph 5 of the Notice of Appeal that certified that she had provided all necessary documents upon which she relies for her claim to the Administrator and does not intend to file any further documents with the Administrator.

[5] The file was forwarded to the Referee on June 11, 2001. Following the preparation and filing of her Notice of Appeal, the Claimant retained counsel and advised the Referee that she requested an in-person hearing. Initially, a hearing date was set for September 13, 2001, which date had to be postponed due to the inability of Fund Counsel and her witness to travel to Saskatchewan because of the tragic events of September 11, 2001. At the request of the Referee, each party provided advance written submissions. On September 10, 2001, the Claimant's counsel provided the following submissions:

Introduction

1. (Claimant) resides in (small community), Saskatchewan. She has submitted a claim as a primarily infected person under the HCV Transfused Plan. Her claim has been denied by the fund administrator.

Facts

2. (Claimant) was born on …., 1923 in the (same) area. She lived in a farm and raised four (4) children.
3. On September 22, 1987, (Claimant) had an operation at the Regina General Hospital, at which time she received two units of blood by way of a transfusion.
4. (Claimant) was subsequently diagnosed with Hepatitis C.
5. (Claimant) has no risk factors for contracting Hepatitis C other than the blood transfusion of September 22, 1987. Her lifestyle was not such that any other risk factor for contracting Hepatitis C would exist. In particular, the following facts are relevant:
· (Claimant) was not a drug user
· She did not inject drugs
· She did not inhale cocaine
· She did not have any body piercing, nor even pierced ears
· She has had no tattoos
· She has not had any accidental needles pricks
· She has not worked in a hospital
· She does not know of anyone who has Hepatitis C that she could have contracted it from
· She did not share toothbrushes or razors
· She did not have sex with anyone except her husband and had no sex at all since 1975 when she had a hysterectomy.

6. (Claimant) is entitled to compensation under the Transfused HCV Plan as there is no other source that she got Hepatitis C from and therefore, she was infected with the Hepatitis C as a result of the blood transfusion she received on September 22, 1987.

[6] Fund Counsel's written position, dated August 17, 2001, is as follows:

Introduction

1. …(Claimant's) claim has been denied because the Traceback indicated that the blood with which she was transfused was not infected with the Hepatitis C virus.

Facts

2. (Claimant's) claim indicates that she attended at the Regina General Hospital in September 1987 for a cholecystectomy and internal drainage of a pancreatic abscess. At that time, she received two units of blood. She was later diagnosed with Hepatitis C.

3. As part of the class action settlement, the Administrator is required to conduct a Traceback in respect of the units of blood transfused to determine if the transfused blood was the source of the Hepatitis C virus. The Traceback procedure has been approved by the Ontario Court (General Division.)

4. As part of the Traceback procedure, the Canadian Blood Services traced the origin of the blood product received by (Claimant) to determine whether the donor was infected with Hepatitis C. The donor was not infected with Hepatitis C and the blood received is determined not to be infected with the virus.

5. On September 19, 2000, the Canadian Blood Services notified the Claims Centre and (Claimant) that the donor of the blood received by (Claimant) did not have the virus and therefore (Claimant) was not transfused with blood contaminated with the virus…

Administrator's Response

6. The Administrator properly determined that (Claimant) is not entitled to compensation under the Transfused HCV Plan, as she was not infected with Hepatitis C as a result of the blood transfusion she received.

[7] The hearing date was re-scheduled to November 27, 2001, at which time viva voce evidence was lead by both parties. The Claimant testified on her own behalf, as did a member of her local community. 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. At the end of the day on November 27, 2001, due to circumstances described below, the matter was adjourned. In the result, the matter will now be adjudicated upon based on the written materials and testimony provided by the parties both at the hearing and afterwards. In the case of records supplied after the hearing, they have been accepted as evidence in the matter, in the same manner as if they had been tendered at the hearing, and marked as exhibits accordingly..

B. Facts, Summary of Evidence

[8] 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. While there are many possible sources of infection with respect to the Hepatitis C virus, the Plan only provides compensation for individuals who received transfusions of defined blood products during the Class Period.

[9] The Claims Center file, consisting of 41 pages, was entered as Exhibit 1 at the hearing. In the Claimant's General Claimant Information Form (TRAN 1) dated May 6, 2000, the Claimant stated that she had received blood transfusions "once" in Canada in her lifetime, during the class period. In her accompanying Declaration (TRAN 3) dated June 12, 2000 , the Claimant stated that to the best of her knowledge, information and belief, she had resided in Saskatchewan during the Class Period, more specifically on September 22, 1987. The Claimant further declared it to be "true" that to the best of her knowledge, information and belief, she "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 declared it to be "true" that she "has never at any time used non-prescription intravenous drugs."

[10] The Treating Physician Form ("TRAN 2") was completed by Dr. M., the Claimant's physician on June 6, 2000 in which Section F - Box 2 was checked off as "yes" following the statement: "Having regard to the definition of blood, did the Primarily Infected Person receive a blood transfusion during the period January 1, 1986 to July 1, 1990?" "None" was checked off under 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. In this box, Dr. M. indicated the following, beside the reference to "Prior significant surgeries or trauma": "hysterectomy age 51." This form also indicated that the physician had known and treated the Claimant for 10 months." Dr. L-W, the Claimant's physician at the time, wrote on November 9, 2000 that the Claimant received a blood transfusion on September 22, 1987, following abdominal surgery and that she "was subsequently diagnosed with Hepatitis C as a result of this blood exposure."

[11] Exhibit 2 is a Report of Transfusion-Related Infection, dated August 31, 2000, with respect to the Regina General Hospital. The latter record refers to two Unit numbers of "RBC", both drawn on August 26, 1987 and administered to the Claimant on September 22, 1987. The first unit donor was shown as tested on January 17, 1997 and the second unit donor as tested on July 16, 1998. The Laboratory Manager at the Provincial Lab signed the form and the results were shown, in the case of each unit donor, as "negative."

[12] Exhibit 3 consisted of records from Regina General Hospital of September 16, 1987, which showed the tags from the two units of packed cells, the numbers of which co-related exactly with the units of blood in the Report of Transfusion-Related Infection (Exhibit 2.)

[13] Exhibit 9 is a letter from the Canadian Blood Services (CBS) to the Claims Centre Traceback Coordinator, dated June 28, 2001, appending a letter from the Regina Health District (owner and operator of Regina General Hospital) to the Claimant, dated February 12, 1999. This letter advised the Claimant that blood banking records at the Pasqua, Plains and Regina Hospitals, being the only hospitals in Regina, all of which are owned and operated by the Regina Health District, had been reviewed. The letter further refers to the same two unit numbers, confirms that the Claimant received such products and indicates: "No records of transfusion at Pasqua Hospital and Plains Health Centre".

[14] During his opening remarks, learned counsel for the Claimant indicated that the burden of proof upon the Claimant to establish that she received infected blood was on a balance of probabilities. In order to counter the negative Traceback results, counsel invited the Referee to consider 3 issues:

1. Negative risk factors from any other sources.
2. Concern that there may been an error in determining who are the donors, what blood was received and from whom.
3. That the concept of negative testing was not necessarily determinative of the issue. There is a percentage of error involved in such testing, such that the results may show negative but the Claimant could still have contracted HCV through transfusion.

[15] Claimant's counsel contended that the Claimant is disadvantaged in dealing with these issues by the inability to obtain information from the CBS or the Regina Health District as to the identities of the donors, in order to permit counsel to question such donors and to determine possible transcription errors as well as evidence with respect to the continuity of the samples. There could well have been an error in collection, labeling or recording. Claimant's Counsel filed a number of media and journal articles which he suggested support the proposition that there are indeed errors on the process, as well as the concept of false negative testing, even if you do have the right donor.

[16] The Claimant testified on her own behalf. She was born in 1923, making her 78 years of age at the date of the hearing. She grew up in the same area as that in which she presently resides, being the 7th of 10 children. She lived on a farm where her family was involved in a mixed farming operation, including grain, poultry and cattle. No one else in her family is infected with Hepatitis C nor has she knowingly associated with anyone who was so infected. She was married in 1945 and remains married today. Her husband is home with cancer. After she was married, she had 4 children, born in 1948, 1951, 1956 and 1958. As to her general health background, she had surgery for varicose veins in 1974 at the Plaints Health Centre, a hysterectomy in 1975 at the Pasqua Hospital and the surgery in question, namely a cholecystectomy at Regina General Hospital in September 1987. She has no knowledge of any transfusions apart from the 1987 surgery. In respect of the latter surgery, she describes having had a history of chills, attending at her local hospital and being sent to Regina, at which time it was determined that she was suffering from blood poisoning as a result of a cyst on the pancreas, resulting in a fever of 104 and requiring her to be rushed into surgery on September 22, 2987, after the blood poisoning had cleared. She was in hospital for a month. After she was released, she was weak for a while and then started losing weight and she kept getting worse. She lost her appetite, had no energy and got played out easily. She had no lack of energy before the 1987 surgery and had milked the cows, did the chores and helped her husband with the farm duties. Some time later she received a letter advising her to get her blood checked and was advised through a local health nurse that she had tested positive for the Hepatitis C virus. Dr. F., her physician at the time, has since moved to Alberta. He referred her to Dr. K., who has since moved to Ontario. She was then referred to her present physician, Dr. M. in Regina. She then testified to her lifestyle and lack of risk factors as identified in her counsel's written submissions. Fund Counsel did not cross-examine the Claimant.

[17] The Claimant also called a retired male character witness, who lives in the same area as the Claimant. This witness described the Claimant as a very attractive lady who, as far as he knows, leads a clean life. She has never had a reputation for having sex with anyone other than her husband and he has never heard a bad thing about her. She is a church going person. Again, there was no cross-examination.

[18] Claimant's counsel filed a number of journal, media and website articles, including:

Exhibit 4 - "Reporting of near-miss events for transfusion medicine: improving transfusion safety", (Callum et al, Transfusion, Vol. 41, October 2001, 1204) [Out of a total of 17,465 units of RBCs, this study referred to 3 samples collected from the wrong patient, 13 mislabelled samples and 22 request for blood of the wrong patient].

Exhibit 5 - "Serious Hazards of Transfusion", Annual Report, 1998-1999 (the "SHOT" Report", E.M. Love, et al.) [This report documents procedural errors in prescription, handling, transportation and labeling.]

Exhibit 6 - "What is Hepatitis C", Hepatitis C Society of Canada Website, August 17, 2001 [This document suggests that lab tests four the antibody to HCV can detect 95% of persons who have the antibody in their blood}.

Exhibit 7 - "New Study Suggests Possible Clinical Benefit Using Newer Test for Detecting Hepatitis C", HepNet (The Hepatitis Information Network) web-site, November 15, 2000) [At page 63, it is pointed out that sensitivity of the third generation enzyme screening testing was greater than 99% in immunocompetent individuals and 60% to 90% in immunocompromised hosts, with a specificity of 99.3%].

Exhibit 8 - "Hepatitis C", Petruff Cheney et al, Infectious Disease Clinics of North America, Infections of the Liver, Vol. 14, Number 3, September 2000, p. 633)

[19] Learned Fund Counsel tendered the following journal articles at the hearing:

Exhibit 10 - "Hepatitis C - Medical Information Update", Canadian Liver Foundation, funded for development and distribution by Health Canada
[This document indicates that in 10% of the cases, the source of HCV infection cannot be identified].

Exhibit 11 - Newsletter, 1st Canadian Conference on Hepatitis C, Vol. 1, Number 1, May 3, 2001 [This indicates that 10% of cases have no clearly identified source of infection].

[20] However, Fund Counsel strenuously objected to the lack of notice by Claimant's counsel as to his intention to file these materials and indicated that she was not in a position to review and respond to those materials on the day of the hearing. She advised the Referee that she would require an adjournment in order to permit expert consideration of these articles and possibly further expert testimony in respect thereof. This requested was acceded to by the Referee, on terms set out later. Nevertheless, at the request of the Referee, Fund Counsel did proceed to call such evidence as was available that day, from Carol Miller.

[21] Ms. Miller's impressive background includes 23 years in nursing, in Nova Scotia, Newfoundland, Manitoba and Ontario, and in virtually every hospital department, including but not limited to such areas as surgery, medicine, emergency medicine, maternity, operating room, recovery room, pediatrics and geriatrics. She has extensive experience with the cross matching and giving of blood in her capacity as a nurse.

[22] Ms. Miller reviewed the records with respect to the Claimant as contained in Exhibit 1. She noted the Claimant's Authorization to Initiate Traceback Procedure" (TRAN 4) and Blood Transfusion History Form (TRAN 5) the latter document being used to compare with transfusion records in order to ensure the correct dates are considered. The PCR test Result Report Form, dated June 2, 2000, based on a sample collected on May 9, 2000, showed the Claimant as "Positive". The ALT testing of March 10, 2000 indicated the condition at Level 3. TRAN 2, the Treating Physician Form, indicated that Dr. M. was of the view as of June, 2000 that the Claimant has bridging fibrosis based on a liver biopsy demonstrating fibrous tissue in the portal areas of the liver with fibrous bands bridging to other portal areas or to the central veins but without nodular formation or nodular regeneration, or Disease Level 4. In reviewing the letter from the Department of Pathology of the London Health Sciences Centre, dated July 27, 1999, she was of the view that the interpretation of the liver biopsy result was supportive of a Level 4 determination.

[23] Ms. Miller then testified to the Traceback procedure. The Centre sends in the antibody test (normally, proof of Hepatitis C is needed before the Traceback commences), the claimant's consent and any transfusion records to CBS. CBS then puts the numbers into their system for donor numbers. After 1990, they would invariably have records of tests results or if not, they asked the donors to come in. If there were no other records of donor testing, they would ask for permission to test. Donors have a choice of the CBS or private labs. In this case, the donors' records were already on file in 2000, when the information was requested. The Centre also requests copies of hospital records in order to ensure that they have the correct information. CBS searches blood bank records for blood products that were transfused. They do not necessarily review blood that was cross-matched but not transfused. In this case, the hospital records confirmed the unit numbers and showed the donors thereof as having tested negative.

[24] Upon a detailed review of the materials provided by the Claimant, CBS and Regina Health District, the Claims Centre was in a position to assess the claim. In accordance with the court-approved Traceback protocols as contained in the settlement agreement, and on the website, the claim in this case was properly denied. Exhibit 3 supported the decision. As to cross matching, blood is taken from donors and reserved for patients in need of blood. Blood is taken to the hospital labs, which then find matching blood, label it and save it for the patient. The patient ultimately may not require all of the cross-matched blood. Units of cross-matched blood are then tagged to match with the patient's name and hospital number as on her armband, together with the patient's blood group, donor's blood group, and unit numbers. The tag is taken off the bag containing the unit of blood and then placed on the patient's health record once used. Exhibit 3 shows that 2 units were used out of the total 3 units that were cross-matched and reserved for the Claimant. The unit numbers on the tags match the unit numbers on the Traceback.

[25] There are numerous methods of contracting the Hepatitis C Virus (HCV) other than blood transfusions, including contaminated instruments. In this case, she wonders whether a scope was used - did they try to look at her pancreas? Scopes can become contaminated with blood and then cleaned and reused, although standards are much better now than they were some years ago. Spending one month in hospital is also a significant risk factor. Possibly, the Claimant may have become infected due to exposure to blood-borne diseases. The Claimant's previous surgical procedures also constituted significant risk factors. The use of catheters, oral airways, intubation tubes and the like, all create risk. While most of these are now thrown out after single use, this was unfortunately not previously the case. Research, including that set out in Exhibit 10 (the SHOT Report) shows that there is 10% of the Hepatitis C population in which the source of the infection cannot be identified. She is aware that Dr. Robert Remus, a professor in the Department of Public Health Sciences at the University of Toronto, testified, when the settlement agreement was approved, to the effect that there are people for whom no explanation as to why they have been infected has been identified, when the disease cannot be connected to blood transfusion.

[26] Under cross-examination, Ms. Miller acknowledged:

§ It is possible to make mistakes.
§ It is possible to have errors in the numbers.
§ The Traceback did not deal with the third unit reserved and cross-matched but not transfused.
§ Claimant was not entitled to access information about the donors, based on the key requirement of confidentiality with respect to donors.
§ She was not sure if donors were required to provide identification as of 1987.
§ Mistakes can be made at the Blood Donor clinic level, where they were generally looking to ensure that blood was not rejected.
§ There could have been a mistake with respect to the 3 bags of blood taken.
§ Some hospitals keep bags of blood in blood banks, whereas some bring bags into the operating room.
§ She had no information to suggest that there were problems at Regina General Hospital, whereby the Hepatitis C virus was being transmitted to patients by way of unsterile surgical instruments.

[27] Following the conclusion of the first day of hearing, the Referee sent a letter to counsel, dated December 2, 2001, setting out the ground rules for the continuation of these proceedings in the following terms:

1. By December 6, 2001, Mr. Balacko will provide written notice to Ms. Horkins, with a copy to me, advising as to whether or not he intends to request additional health records (including hospital records from prior surgical procedures and/or clinical records or office charts of past or present physicians, if available) to tender with respect to this Reference. If Mr. Balacko intends to request additional health records, he will at the same time provide Ms. Horkins and myself with copies of his letter(s) requesting such additional materials.

2. If, upon review of such requests for records, if any, Ms. Horkins is of the view that she wishes to request health records in addition to those that Mr. Balacko might request, she will advise Mr. Balacko, with a copy to me, as to what she seeks. She will also cover the reasonable costs of obtaining any such additional records. Mr. Balacko will assist in facilitating such requests, either by obtaining (Claimant's) consent to the release of such records to Ms. Horkins or by amending his requests for information to address Ms. Horkins' requirements. While we did not discuss any specific dates for Ms. Horkins to finalize such requests, I ask that this be concluded by December 13, 2001. Copies of any such records so obtained by either party shall be provided to the other counsel as soon as they are received. If difficulties are encountered in obtaining such information, I would be pleased to consider any requests for my assistance in that regard.

3. Ms. Horkins shall have until February 5, 2002 (if no additional records are requested by Mr. Balacko) or 60 days from the date of her receipt of the last of the health records that are so requested, to advise Mr. Balacko and my office in writing as to whether or not she intends to file additional materials or tender additional evidence and if so, to provide a brief advance summary of same as well as a proposal for the mechanics of the tendering of such evidence.

4. Within 30 days of receiving notification from Ms. Horkins as to her intentions with respect to the matter of calling additional evidence, Mr. Balacko will provide written notice to Ms. Horkins and myself advising whether he proposes to tender any additional materials or call further evidence to rebut any new evidence that Ms. Horkins may propose to tender. He will also provide a brief advance summary of same as well as a proposal for the mechanics of tendering such evidence.

5. If there are any difficulties in interpreting, applying or complying with the foregoing, I invite either counsel to notify me in writing so that I can arrange a conference call with counsel to assist in the resolution of same.

I appreciate that the practical result of applying the foregoing time periods may be to delay the conclusion of this matter considerably. However, I do not see any other option, given:
(a) The need to ensure that both parties are provided with the opportunity to fully address the issues raised;
(b) The need to ensure that no party is unduly taken by surprise;
(c) The objective of minimizing the risk of requests for further adjournments; and
(d) The potential difficulties associated with reliance on others to provide materials and/or opinions.

At the same time, I fully anticipate and expect that counsel will take all reasonable steps to meet or expedite these time frames where at all possible.

[28] By letter dated December 6, 2001, Mr. Balacko provided copies of letters from Dr. L, dated November 29, 2001 and December 6, 2001, which have been received into evidence as Exhibits 12 and 13 respectively. He further advised that the Claimant would not be requesting any additional health records The first of these letters indicated that the Claimant's liver function tests at the time of her 1986 surgery were normal. Her family practitioner's notes and the surgeon's notes in the months following her surgery indicated that she did have episodes of upper abdominal pain but ultrasound did not reveal any upper abdominal abnormalities. She was assessed in 1990 by another surgeon for vague upper abdominal discomfort and again ultrasound revealed no abnormality of the pancreas or upper abdomen. He states that the Claimant "did complain of some upper abdominal discomfort following her surgery and following her blood transfusion (of September 22, 1987) and upper abdominal pain specifically the right upper quadrant can be suggestive of Hepatitis C infection." In his letter of December 6, 2001, Dr. L. states:

With regard to the source of (Claimant's) Hepatitis C infection, from my experience it would be extremely unlikely to obtain Hepatitis C from her surgical procedure or from unsterile equipment. In my experience I have never had a case of Hepatitis C due to an unsterile surgical technique or equipment.

[29] By letter of December 10, 2001, Claimant's Counsel advised Fund Counsel that he did not intend to file further materials. Fund Counsel wrote to Claimant's counsel on same date requesting a copy of Dr. L's C.V., a complete listing of all documents reviewed by Dr. L., complete list of all hospitalizations and dates and names of hospitals relating to the claimant, a complete list of all doctors of the Claimant and Consents for the Claimant to sign to enable the Administrator to obtain copies of records from such physicians/hospitals.

[30] Claimant's counsel cooperated in obtaining the Claimant's consent to the release of such records. Ultimately, under cover of letter dated April 17, 2002, Fund Counsel supplied 457 pages of additional health records that had been obtained relative to the Claimant, numbered pages 42 - 499, received into evidence collectively as Exhibit 14, consisting of:

1. Medical records from Dr. L (pages 42-60).
2. Medical records from the Claimant's local Hospital (pages 61-441).
3. Fax cover sheet from Regina Health District, March 13, 2002 (page 442).
4. Medical records from Regina Health District (pages 443-452).
5. Medical records from Dr. M. (pages 453-499).

[31] Fund Counsel took the position that it appeared that Dr. L. had not reviewed the complete medical file for the Claimant. The following references to the records set out in Exhibit 14 are relevant to Fund Counsel's position that the Claimant suffered from a pre-existing hepatitis condition:

[emphasis added throughout]

[32] On May 13, 2002, Fund Counsel tendered a letter from Dr. Curtis Cooper, dated May 6, 2002, who had reviewed the health records with respect to the Claimant. This report has been received into evidence as Exhibit 15. Dr. Cooper is with the Division of Infectious Diseases, Ottawa Hospital-General Campus, University of Ottawa. For the past 5 years he has provided clinical care for patients infected with HCV. He took a lead role in establishing the Viral Hepatitis Clinic at this hospital and currently actively follows 300 patients with chronic HCV. He is a member of the Canadian Viral Hepatitis Network, an organization of Hepatologists and Infectious Disease Specialists with clinical and research expertise in viral hepatitis. He is currently actively involved in clinical research concentrating on the investigation of the epidimiology, manifestations and treatment of HCV. His letter states:

… Having reviewed this case, it is my opinion that the patient acquired chronic hepatitis C infection as a result of another (i.e. other than the blood transfusions received in September, 1987) exposure for the following reasons:

1. Blood Traceback
The tests used to evaluate blood are very sensitive for identifying the presence of the hepatitis C antibody, if present. In other words, if hepatitis C antibody were in these blood specimens, then it would have been identified. Therefore, I am in agreement with the CBS conclusion that this patient was not exposed to hepatitis C as a result of the transfusions received in September of 1987.

2. Liver Biopsy
The Liver Biopsy in this patient demonstrated stage 3 fibrosis consistent with long-term, chronic hepatitis C infection. The biopsy was performed approximately twelve years after this patient's blood transfusion. To have this degree of fibrosis after this period of time seems unlikely, in particular to a woman with no other risk factors for accelerated progression of chronic Hepatitis C infection such as chronic alcohol use or co-infection with HIV or hepatitis B virus. This degree of scarring is more consistent with twenty to thirty years of infection.

3. Liver Enzymes (i.e. ALT, AST)
In reviewing this patient's medical history from 1972 to February of 2002, it is observed that this patient has had chronic and consistent elevation in her ALT and AST since at least September 1977 (when results are first available). This patient is hepatitis B surface antigen negative which rules out chronic hepatitis B disease. This patient has been on several medications over the past two decades, however, none over the entire period of time. This excludes drug-related hepatoxicity as an explanation for this persistent elevation of liver enzymes. The liver biopsy did not suggest the presence of other underlying liver disease such as hemochromatosis, alpha-1 antitrypsinase deficiency, autoimmune hepatitis, drug toxicity, or chemical toxicity. Of note, serology evaluating for autoimmune disease was consistently negative in this subject. This persistent elevation of liver enzymes, in the absence of an alternative explanation, suggests that this patient was chronically infected with hepatitis C since at least 1977.

4. Risk Factors
… I do note that in 1975, this patient had a dilatation and curettage performed for menorrhagia. Although the records suggest that this patient did not receive a blood transfusion with this procedure, it is possible that this information was not documented. Of great relevance to this case is the fact that (Claimant) underwent allergy testing in 1972. This procedure requires the use of multiple needles. Furthermore, for the decade following this procedure, the patient received injections for her allergy conditions (the exact duration and frequency of these injections is not clear from the medical history provided. It is unclear whether the needles used in the treatment of this patient's allergic condition were reused, and if so, if they were sterilized properly. The reuse of needles for medical procedures is a risk factor for the acquisition of HCV. I speculate that (Claimant) acquired chronic hepatitis C as result of allergy testing or treatment.

I was asked to comment on two other specific details of this patient's medical history.

1. Jaundice as Child
… Approximately half of newborn patients are jaundiced in the first week of life and it is possible that this was the case in this instance. It is possible that this patient was infected with acute Hepatitis A as a child, which would have resulted in a brief period of illness and jaundice (N.B., there is no chronic form of hepatitis A). It is possible that as a child, this patient was infected with hepatitis C with transient jaundice. This scenario is unlikely given the absence of risk factors for hepatitis C infection during childhood (i.e. blood transfusions, tattooing).

2. Pesticides Related Hepatotoxicity
The lawyer representing (Claimant) suggested that the increase in transaminase level occurring in the late 1970's was a result of crop spraying. Certainly, several pesticides used in agriculture can cause acute hepatotoxicity associated with profound illness consisting of nausea, vomiting, headaches, fatigue, malaise and skin rash. None of these symptoms were reported in the medical records provided. Furthermore, I observe that this patient's transaminase levels were elevated in September 1977, December 1977 and February of 1978. There would have been no crop spraying occurring during these months in Saskatchewan. These persistently elevated transaminase levels are more consistent with the presence of an on-going, chronic viral infection such as Hepatitis C.

In conclusion, this patient is infected with chronic HCV with persistently elevated transaminase levels and stage 3 fibrosis on liver biopsy. The weight of evidence suggests that this patient was not infected in September 1987 as a result of receiving two blood transfusions … The evidence suggests that this patient has been infected with chronic hepatitis C for a longer period of time, however, the exact infection and mechanism by which she was infected is uncertain.

[emphasis added throughout]

[33] From the date of Dr. Cooper's report forward, there were numerous delays, mostly with consent of counsel, while counsel for the Claimant considered the issues of whether further evidence would be tendered and both parties considered how the hearing would be concluded. Various conference calls were held and correspondence exchanged in that regard. Ultimately, counsel for the Claimant advised the Referee that no further evidence would be tendered. Both parties agreed that there was no need to reconvene the in-person hearing, but that the parties would provide final written submissions, following receipt of which the Referee would be in a position to adjudicate upon the matter.

C. Analysis

[34] In the Claimant's final written submissions, learned counsel reiterated the healthy lifestyle facts relative to the Claimant and continued to take the position that there is substantial room for error in either the recording of the transfusion records or the traceback procedure. It was further argued that in the 1980s there was no requirement that photo ID be provided to identify donors. Mistakes could be made in the collection process which would allow the donation to be mislabeled to another person's identification. Three bags of blood were brought up from the hospital lab, of which only two were used. An error could have taken place in which the tags from the bags were mixed up. In light of the CBS' refusal to provide the names and addresses of the donor that were tested, how can it be said that the donors are not positive? In order to eliminate the possibility that the wrong bag was used, the third donor should also have been tested. All three donors should have been re-tested with the most up-to-date and sensitive test and should be interviewed. Only if such re-testing and interviewing led to the conclusion that the donations were negative should the administrator be held not responsible for the Claimant's illness.

[35] In critiquing Dr. Cooper's report, Claimant's counsel placed a great deal of reliance on the submission that the Claimant only experienced symptoms after 1987, at which time she lost strength, appetite and weight. Counsel also argues that it is quite possible for a person to develop the extent of the scarring that is shown to exist for the Claimant in the 14 years after the 1987 operation. It is argued that Dr. Cooper's speculation over the needles being used on the previous allergy testing being reused or infected and speculation as to possible infection relating to the surgery in 1972 is just that - speculation. This speculation should be no more persuasive than the Claimant's speculation that there was poor procedure followed during the blood collection/donation process. Claimant's counsel also noted that the Claimant was referred to University Hospital in Saskatoon in 1978 to attempt to determine why she had elevated liver enzymes. There is a report from Dr. Buchan, Gastroenterologist, at page 60 of Exhibit 14 which, it is argued, conclusively rules out any contention that the Claimant had HCV at an earlier point in time. Medical personnel clearly thought the elevated liver enzymes were as a result of other causes. Counsel submits that the elevated liver enzymes were related to the Claimant's allergic reaction to the pesticides used in the farming process.

[36] In conclusion, counsel for the Claimant submits that all of the above factors support the conclusion that it is more likely than not that the Claimant contracted the Hepatitis C infection from the 1987 transfusions.

[37] In her reply to the Claimant's final submission, learned Fund Counsel argued that there was no evidence that there was "substantial" room for error in the blood transfusion records, merely an acknowledgement from Ms. Miller that people can make mistakes, not that one happened here. As to Mr. Balacko's submission that the third bag that was reserved but not transfused ought to have been tested, Ms. Horkins replied that the Settlement Agreement only requires a traceback to be conducted on the units that are transfused. As to Mr. Balacko's argument that Dr. Buchan at University Hospital ruled out the possibility of a Hepatitis C infection, Ms. Horkins pointed out that Dr. Buchan simply states that there "is no underlying disease apparanet such as chronic active hepatitis." This does not mean that he was ruling out Hepatitis C as indeed testing was not available in 1978 to discover the disease. Ms. Horkins further submits that Dr. Buchan's comment was based on what was available to him in 1978. Dr. Cooper, on the other hand, has reviewed the complete medical brief including the chronic and consistent elevation in the Claimant's AOT and AST readings since at least September 1977 when the results were first available. These results ruled out chronic Hepatitis B disease which is probably what Dr. Buchan was referencing. Dr. Cooper provided his opinion based on a review of the complete medical brief and based on the knowledge that is available today concerning Hepatitis C.

[38] 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) On September 22, 1987, (Claimant) had an operation at the Regina General Hospital, at which time she received two units of blood by way of a transfusion. A third unit of blood was reserved for but not transfused to the Claimant at that time.
(d) The Claimant has established that she received defined blood transfusions during the Class Period.
(e) Tracebacks were conducted with respect to the two units of blood transfused to the Claimant during the Class period. In each case, the tracebacks proved negative (the donors of the Blood received by a person claiming to be a Primarily-Infected Person during the Class Period were determined not to be HCV antibody positive.)
(f) The evidence, particularly as summarized by Dr. Cooper, convincingly establishes that, albeit it unbeknownst to her, the Claimant was infected with HCV long before the 1987 transfusion.

[39] 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]

[40] Subsection 7(a) of the Traceback Protocol directs the Administrator, as provided in subsection 3.04 (1) of the Plan text, 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 results, as provided in subsection 3.04(2) of the Plan text.

[41] It must be 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, even though this need only be established on a "balance of probabilities" standard, given the Claimant's lack of access to the donor's private records.

[42] Nevertheless, in considering the matter of whether the Claimant has met the reverse onus requirement of subsection 3.04(2) of the Plan, had matters been left to be determined on the basis of the evidence as introduced by the end of the day on November 27, 2001, the evidence of the Claimant's risk-free lifestyle, exemplary character and lack of other explanations for how she may have contracted HCV, coupled with the timing of the Claimant's onset of symptoms, may arguably have been sufficient to meet the onus. While the analogy is less than exact, the reverse onus could be likened to the breathalyzer provisions of the Criminal Code, under which a rebuttable presumption arises as to the validity of such readings, which may be challenged by way of "evidence to the contrary." This is sometimes successfully accomplished in the context of criminal cases by way of credible evidence of consumption patterns that render the breathalyzer readings unreliable. However, in such cases, there is a short and readily ascertainable window of time that is relevant and only one source or manner of ingesting alcohol. In the Claimant's case, the time frame under consideration is neither short nor clearly identifiable, and the other potentially causative factors of transmission of HCV are vast, evolving and in some cases will remain unidentified. Given the lack of precision of some aspects of the scientific understanding of the methods of transmission of HCV, it must be acknowledged that there is some possibility that the Traceback was inaccurate and that the Claimant did contract HCV from a transfusion of blood during the Class Period. However, without specific evidence that refutes the traceback findings, particularly given the convincing analysis of Dr. Cooper that deals with each of the arguments advanced by the Claimant and offers more plausible explanations, these possibilities do not rise to the threshold requirement of probability, so as to satisfy the Claimant's burden of proof. To find otherwise would essentially render the Traceback procedure meaningless and would require a Referee to exceed the jurisdiction conferred by the Settlement Agreement. While the matter cannot be said to be entirely free from doubt and the temptation to assist the Claimant is strong, a careful analysis of the evidence presented leads inexorably to the conclusion that the Claimant has failed to refute the Traceback procedure.

[43] It is useful to bear in mind other decisions which bear specifically on the issue of the importance of the court approved Traceback Protocol in the overall functioning of the Plan, including:

Confirmed Referee Decision # 39 - February 6, 2002, John P. Sanderson, Q.C. , Referee, as upheld on June 14, 2002 by a decision of the court having jurisdiction in the Class Action (The Honourable Mr. Justice Pitfield.)

Confirmed Referee Decision # 29 - December 21, 2001, Shelly Miller, Q.C., Referee

Confirmed Referee Decision # 42 - March 11, 2002, Judith Killoran, Referee

Confirmed Referee Decision # 59 - September 18, 2002, Martin Hebert, Referee

Arbitrator Decision # 54 - August 15, 2002, Vincent R.K. Orchard, Arbitrator

Arbitrator Decision # 40 - February 16, 2002, Tanja Wacyk, Arbitrator

[44] While there was some evidence adduced in this case that a Referee could certainly consider on the issue of whether or not the Claimant had "refuted the results of the Traceback Procedure," it is with great regret, in view of the Claimant's circumstances, that there was insufficient evidence when weighted against Exhibits 14 and 15 and the balance of the evidence, to refute the Traceback results.

[45] The Claimant's evidence was presented in an honest and forthright manner and it has been accepted without hesitation. The Claimant has throughout her lifetime been a productive, hard-working and impressive individual, who has contributed a great deal to her family and her community. She could no doubt benefit considerably from a finding that she falls within the parameters of the Settlement Agreement, to assist her in the financial repercussions of a serious illness that she played utterly no part in contracting and could not have prevented. She has arrived at a point in her life where she fully deserves to be enjoying her time and her family in reasonable health, without financial hardship and worry over her condition. If need and character were the guiding principles in establishing a claim, the Claimant would succeed hands down. However, a Referee simply has no discretion to grant compensation to individuals infected with HCV who cannot show that they come within the parameters of the Settlement Agreement and Plan text.

[46] This process must have been particularly frustrating for the Claimant in that she did establish the threshold requirement that a blood transfusion was received during the Class Period. To learn at this time of the undiagnosed probable existence of HCV for many years prior to her transfusion would likely add to this frustration. One cannot help but have considerable empathy for the Claimant in all the circumstances.

[47] This was not a straightforward case. If there was any way for the evidence to have been interpreted such that in the end result the Claimant could be awarded compensation, I would have not hesitated to do so. Based on the foregoing facts, however, the Administrator's denial of the Claimant's request for Compensation must be upheld.

[48] 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.

D. Decision

[49] 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 14th day of January 2003.

________________________________
DANIEL SHAPIRO, Q.C.
Referee