IN THE MATTER OF an appeal filed pursuant to the Rules for Appeals under the Pre-1986/Post-1990 Hepatitis C Settlement Agreement and its Protocols

Transcription

1 IN THE MATTER OF an appeal filed pursuant to the Rules for Appeals under the Pre-1986/Post-1990 Hepatitis C Settlement Agreement and its Protocols CLAIM FILE: REASONS FOR DECISION INTRODUCTION [1] The Claimant has appealed a decision of the Administrator dated February 2, 2009, in which the application for compensation under the Pre-1986/Post-1990 Hepatitis C Settlement Agreement ( Settlement Agreement ) was denied on the basis that she did not receive blood in Canada during the Class Period. FACTS [2] On January 15, 2008, the Claimant delivered an application for compensation under the Settlement Agreement. In the General Information Form, she stated that she was a Primarily-Infected Person who was infected with the Hepatitis C virus through a blood transfusion received in Canada during the Class Period. She had no other risk factors for Hepatitis C and has received compensation under a provincial plan and the Red Cross Settlement. [3] In the Treating Physician Form, the treating physician indicated that the Claimant was at Disease Level 3; he had treated her for four years. In Section F HCV Disease Verification, he indicated that the Claimant had no risk factors for Hepatitis C and had received blood during the Class Period.

2 - 2 - [4] In the Blood Transfusion History, the Claimant stated that she had received a blood transfusion in the summer of 1985 at Hospital A for haemorrhaging. [5] The Claimant delivered laboratory records dated April 17, 1996 and October 24, 2003 with the application forms; the records respectively indicated a positive Hepatitis C antibody test and a positive PCR test. She also included documents from her application for compensation in the provincial plan. It is unnecessary for me to make any reference to the documents from the provincial plan application. [6] By letter dated July 10, 2008, the Canadian Blood Services forwarded the Traceback report to the Administrator. The Traceback indicated that there was no record that the Claimant was admitted to Hospital A. [7] By letter dated November 26, 2008, the Claimant advised the Administrator that she was admitted to Hospital B on November 1 and 2, [8] On December 1, 2008, the Claimant delivered records from Hospital B relating to treatment received for vaginal bleeding on two separate admissions to the Emergency Department on November 1 and 2, [9] An Emergency Record dated November 1, 1984 indicated that the Claimant arrived at the Emergency Department at 0027 hours and was transferred at 0205 hours. The History stated as follows: - Onset painless vaginal bleeding tonight 1 cup blood - had T.A. [therapeutic abortion] 1 mos ago on BCP since feels well 0 meds O/E [illegible] [...] Vag [vagina] blood in vagina 1 tablespoon [...] [Emphasis Added]

3 - 3 - [10] A Nurses Clinical Record from the Emergency Department stated as follows: 0030 Ambulatory [patient] admitted [because of] bleeding. Had an abortion a month ago + says she notice [sic] a discharge + smell + spotting since then. Started to bleed [illegible] about ½ hour ago catheterized [...] 0200 IV commenced. Blood drawn for C + T [crossmatch and transfusion] 0205 Report given to A2. Transferred in stable condition. [Emphasis Added] [11] A Blood Bank requisition entitled Blood Transfusion ( first Blood Bank Transfusion requisition ) was issued at 209 hours for the supply of two units of packed cells that were required for November 1, The word hold was written above the request. The laboratory part of the record indicated that two units of packed cells were prepared for November 1, The diagnosis on the requisition was Vaginal bleeding. [12] A History Sheet dated November 1, 1984 repeated that the Claimant had vaginal bleeding and had bled 1 cup tonight. [13] An undated Physical Examination record stated that the Claimant had one tablespoon of blood in her vagina. [14] On the morning of November 2, 1984, the Claimant was discharged from the hospital. [15] Later on the morning of November 2, 1984, at 1108 hours, the Claimant returned to the Emergency Department due to vaginal bleeding. The History in the Emergency Record stated, in part, that she had a therapeutic abortion a month ago and was bleeding from Wednesday to Thursday (October 31 to November 1). There were blood clots in the vagina; the cervix was slightly opened, and there was a clot in it. The Orders part of the Emergency Record contained various orders and a notation that the Claimant was scheduled

4 - 4 - for surgery at 1530 hours. The orders had the word done written beside them and stated, in part, as follows: C + T [Crossmatch and Transfusion] x 2 IV [...] [Illegible] [Emphasis Added] [16] A Nurses Clinical Record from the Emergency Department contained notations from 1125 to 2000 hours. The note at 2000 hours stated no further bleeding. On the next line, it stated that the Claimant was discharged. It is unclear whether she was discharged at 2000 hours or at a later point in time. The entries in the Nurses Clinical Record indicated that the Claimant was bleeding heavily and stated, in part, as follows: 1125 [...] [Vaginal] bleed here Wednesday - [Saw by] Dr. [...] + admitted [overnight] discharged x 1 day this a.m. Heavy bright bleeding this time of bright blood + clots 1200 IV started [...] 1507 [...] bright red bleeding [...] 1540 To OR 1815 [Claimant] returned from [Recovery Room] [Emphasis Added] [17] A History and Physical Examination Record dated November 2, 1984 was prepared by a physician and described the condition of the Claimant. In particular, he made reference to the quite severe bleeding that she was experiencing. The physician wrote, in part, as follows: This para 0, gravida 2 female has had two abortions carried out in [another province]. The last one was 25 days ago. She claims there were no complications afterwards and five days following the procedure, she was placed on Ortho-Novum, 1/50. She has continued to spot the entire time she was on the pill. She was bleeding more heavily two days ago and was seen by Dr. [ ], who advised her to stop the pill and start a fresh package a week later. However, since that time the bleeding has become quite sever [sic], with large clots being passed, so she returned to Emerg. today. [...] I suspect that [the Claimant] still has some retained products from her original D&C and I think that curettage should be carried out again today and she could be placed on a fresh package of birth control pills following that. [Emphasis Added]

5 - 5 - [18] A Blood Bank requisition entitled Blood Transfusion ( second Blood Bank Transfusion requisition ) was stamped November 2, 1984 and requested the supply of two units of packed cells. The laboratory part of the record indicated that one unit of packed cells was prepared for November 2, [19] A Pre-operative Check List dated November 2, 1984 contained, among other things, laboratory items to be checked before the surgery. Number A6 on the form was Cross and Type Requisition on Chart ; the word Ready was written beside it. [20] An Operative Record dated November 2, 1985 stated as follows: Under general anesthesia, the uterus was seen to be moderately enlarged. The cervix was already dilated and curettage revealed large blood clots and a few shreds of placental tissue still remaining. At the termination of the procedure, bleeding appeared to be well controlled. [Emphasis Added] [21] The Recovery Room Record dated November 2, 1984 made reference to the Ringers Lactate intravenous solution administered to the Claimant. There was no reference to a blood transfusion. [22] By letter dated January 21, 2009, the Canadian Blood Services forwarded the updated final Traceback report to the Administrator, together with the Hospital Response to the Traceback Notice and the Transfusion Summary ( updated Transfusion Summary ). [23] The Hospital Response indicated that the Claimant s patient record was available and she was not transfused; no Blood Bank Records were available prior to 1987 and the Health Records were searched for November The Hospital Response contained a note that said See attached. The attached document was the first Blood Bank Transfusion requisition (dated November 1, 1984), described in paragraph 11. As indicated previously, the word hold was written on the requisition. The copy of the first Blood Bank Transfusion

6 - 6 - requisition that was attached to the Hospital Response contained notes written by the persons conducting the records search. There was a note Was any of the blood transfused; any unit numbers? In a note dated January 21, 2009, a person responded Not given Rechecked with Health Records. Significantly, the second Blood Bank Transfusion requisition (dated November 2, 1984), described in paragraph 18, was not included with the Hospital Response, and there was no mention of it. The second Blood Bank Transfusion requisition did not have the word hold written on it. [24] The updated Transfusion Summary stated as follows: Hospital: [ A ] Comments: North York General reports Timeframe of search Hospital records available: No record of admission to this hospital. Updated Hospital: [ B ] A unit number search was requested from this hospital. The hospital responded: Blood Bank Records: Timeframe of search; No records available prior to 1987 Health Records: Timeframe of search; November 1984 Patient record available; Not transfused There were 2 units placed on hold, no unit numbers provided. Blood was not given. DECISION OF THE ADMINISTRATOR [25] In a decision dated February 2, 2009, the Administrator denied the claim for compensation. In the Reasons for Decision, the Administrator stated as follows: The Settlement Agreement requires the Administrator to determine a person s eligibility for class membership. All the material that you provided to support your claim was carefully reviewed by the Administrator. You have not provided sufficient evidence to support that you or the HCV Infected Class Member received blood during the Class Period, as defined in the Settlement Agreement. [...]

7 - 7 - In your original application you indicated you were transfused at [Hospital A ] in [Hospital A ] confirmed there was no record of you being admitted to that hospital. Upon further investigation you advised the Administrator that you were actually admitted to [Hospital B ] in November Medical records from that hospital were submitted however they confirmed you were crossmatched for two units of blood. 1 A crossmatch is a procedure in which blood is requested and saved in the hospital blood bank; however it is not proof of transfusion of that blood. In cases where the claimant is having difficulty obtaining documents to support they received a transfusion; the traceback department contacts Canadian Blood Services (CBS) to request their assistance in obtaining transfusion information directly from the hospital. CBS advised they contacted [Hospital B ] who stated they searched your health records and you were not transfused. Therefore based on Article (a) of The Pre-86 Post-90 Hepatitis C Settlement Agreement your claim is rejected as there is no evidence of you receiving a transfusion of Blood in the Class Period. [Emphasis Added] REQUEST FOR REVIEW [26] On February 27, 2009, the Claimant delivered a Request for Review, together with copies of the two Blood Bank Transfusion requisitions (dated November 1 and 2, 1984) and various other documents and receipts that are not relevant to the issue raised on appeal. She specified the reasons for appealing as follows: I find the records (Blood Transfusion) confusing + incomplete. I did receive Blood at [...] during this time. [27] The Fund Counsel provided advice and assistance to the Claimant. She also gave the Claimant several extensions of time for the purpose of gathering supplementary evidence. In an dated June 2, 2010, the Claimant advised the Fund Counsel that she was unable to find a specialist to provide an opinion concerning the receipt of blood. She did not deliver any supplementary evidence. [28] On August 9, 2010, the file was received by the Appeals Officer. 1 The Administrator made no reference to the second Blood Bank Transfusion requisition or any other evidence in the medical records.

8 - 8 - ISSUE [29] The issue to be determined is whether the Administrator committed an error in denying the claim for compensation. ANALYSIS i) Eligibility Requirements in Section 2.01 of the Settlement Agreement [30] In the Reasons for Decision delivered on the appeal in Claim File , I dealt with the interpretation of the eligibility requirements in section 2.01 of the Settlement Agreement; on April 7, 2009, a further appeal to the Court was dismissed by Chief Justice Winkler. In interpreting the meaning of the expression received Blood in Canada in section 2.01 of the Settlement Agreement, I stated as follows: [7] Under the terms of the Settlement Agreement, a person claiming to be a Primarily-Infected Class Member, such as the Claimant, must satisfy the eligibility requirements in section 2.01 in order to make a successful claim for compensation. In the circumstances of the present claim, the relevant provisions are subsections 2.01(1) and (2) which state as follows: 2.01 Eligibility Primarily-Infected Class Member (1) A person claiming to be a Primarily-Infected Class Member must deliver to the Administrator an application form prescribed by the Administrator together with: a) medical, clinical, laboratory, hospital, The Canadian Red Cross Society, Canadian Blood Services or Hema-Quebec records demonstrating that the claimant received Blood in Canada during the Class Period; [...] (2) Notwithstanding the provisions of Section 2.01(1)(a), if a claimant cannot comply with the provisions of Section 2.01(1)(a), the claimant must deliver to the Administrator corroborating evidence independent of the personal recollection of the claimant or any person who is a Family Member of the claimant establishing on a balance of probabilities that he or she received Blood in Canada during the Class Period.

9 - 9 - ii) Did the Administrator commit an error in denying the claim for compensation? [31] A review of the decision reproduced in paragraph 25 indicates that the sole evidence relied upon by the Administrator in denying the application for compensation was the first Blood Bank Transfusion requisition that had the word hold written on it. There was no reference in the decision to the evidence concerning the return of the Claimant to the Emergency Department on November 2, 1984 for the treatment of increased vaginal bleeding, her emergency surgery, the second Blood Bank Transfusion requisition and the availability for transfusion of one unit of blood during the surgery. The Administrator therefore erred by not considering the totality of the evidence in arriving at the decision to deny the application for compensation. [32] Since the evidence in the claim file is complete, I have decided to make the decision, rather than returning the matter to the Administrator. 2 [33] The evidence indicates that the Claimant had vaginal bleeding from October 31 to November 2, 1984 due to problems arising from a therapeutic abortion one month earlier. She was admitted to the Emergency Department of the hospital two separate occasions on November 1 and 2, On November 1, 1984, the Claimant had bled about a cup and was kept in the hospital overnight. Two units of blood were crossmatched and ordered for her in the first Blood Bank Transfusion requisition. However, the word hold was written on the requisition. She was discharged from the hospital sometime in the morning and returned to the Emergency Department a bit later, on November 2, 1984 at 1108 hours. At this time, the Claimant s vaginal bleeding had clearly worsened. For example, the vaginal bleeding was described in the Nurses Clinical Record, reproduced in paragraph 16, as heavy bright 2 See, by way of analogy, the approach taken by Rothstein J. in Apotex v. Sanofi-Synthelabo Canada Inc., 2008 SCC 61 at paragraph 72.

10 bleeding and a gush of bright blood and clots. Furthermore, the physician stated in the History and Physical examination record, reproduced in paragraph 17, that the bleeding had become quite severe, with large clots being passed. He also stated that the pelvic examination [...] revealed fairly marked bleeding to be present and a D&C operation [...] should be carried out again today. Blood was ordered in the second Blood Bank Transfusion requisition and one unit was prepared. The Pre-operative Checklist had the word Ready written beside Cross and Type Requisition on chart. The physician stated in the Operative Record, reproduced in paragraph 20, that the D&C operation revealed large blood clots in the cervix. [34] There was no evidence in any of the hospital records to demonstrate that the Claimant had received a blood transfusion. With respect to November 1, 1984, the first Blood Bank Transfusion requisition had the word hold written on it. I am satisfied that the hospital records from November 1, 1984, when considered in their totality, do not demonstrate that the Claimant received a blood transfusion during her hospital admission on that date. However, after her discharge from the hospital early on November 2, 1984, the Claimant s bleeding clearly worsened and required her to return to the hospital. She was bleeding heavily and required surgery on an emergency basis. Furthermore, one unit of blood was available and ready for the surgery. Although there was no mention in any of the hospital records that she was administered the one unit of blood on November 2, 1984, the Blood Bank records were destroyed; only the chart records were available. [35] In the Reasons for Decision on further appeal to the Court in claim file dated October 29, 2009, Chief Justice Winkler allowed an appeal where there was conflicting evidence as to whether the Claimant had received a blood transfusion, stating as follows:

11 In my view, this is a case where the principle that, with respect to class membership, if an error is to be made, it should be made on the side of inclusion rather than exclusion, should be invoked. [36] Given the emergency hospitalization of the Claimant on two consecutive days, the severity of her bleeding, the emergency surgery on November 2, 1984, the second Blood Bank Transfusion requisition, the availability of one unit of crossmatched blood for transfusion during the surgery, the destruction of the Blood Bank records, and the absence of any other risk factors for Hepatitis C, I have concluded that this is an appropriate case for the application of the inclusiveness principle. The Claimant has therefore demonstrated that she received blood in Canada during the Class Period, as required by subsection 2.01(1) of the Settlement Agreement. CONCLUSION [37] The appeal is allowed. DATED August 20, 2010 "D. McGillis" The Honourable D. McGillis, Q.C. Appeals Officer TO: Claimant Fund Counsel Administrator