AQ v Minister for Health

JurisdictionIreland
JudgeMr. Justice Bernard J. Barton
Judgment Date19 July 2016
Neutral Citation[2016] IEHC 429
Docket Number[2015 No. 5 CT]
CourtHigh Court
Date19 July 2016

[2016] IEHC 429

THE HIGH COURT

Barton J.

[2015 No. 5 CT]

IN THE MATTER OF AN APPEAL PURSUANT TO SECTION 5(15) OF THE HEPATITIS C COMPENSATION ACTS 1997/2006

IN THE MATTER OF THE DECISION OF THE HEPATITIS C COMPENSATION TRIBUNAL TO THE CLAIMANT A.Q. 6th OCTOBER, 2015, REFERENCE 4138/08

AND IN THE MATTER OF AN APPEAL OF THE CLAIMANT, A.Q. APPELLANT

BETWEEN
A.Q.
APPELLANT
AND
THE MINISTER FOR HEALTH
RESPONDENT

Compensation – S. 5 (15) of the Hepatitis C Compensation Acts 1997/2006 – Appeal against the decision of Hepatitis C Tribunal – Proof of diagnosis of disease – Standard of proof – Hepatitis C Compensation Tribunal Act 1997 – Interpretation of statute – Plain and natural meaning – Absurdity

Facts: The appellant had filed an appeal against the decision of the Hepatitis C Tribunal refusing to grant compensation to the appellant on the failure to fulfil the statutory requirement for submitting the proof of diagnosis of Hepatitis C. The key issue which needed to be decided was whether the positive tests results carried on a specimen of the appellant could be termed as a positive diagnosis under s. (1A) (a) (i) of the Hepatitis C Compensation Tribunal (Amendment) Act 2006 so as to entitle the appellant to receive compensation under Hepatitis C Compensation Tribunal Act 1997, the purpose of which was to award compensation to the persons who had contracted Hepatitis C within the State from Anti-D or other blood products. The appellant contended that positive ChLIA tests conducted on her blood specimen would came under the ambit of s. (1A) (a) (i) of the Act of 2006 so as to make her entitle to receive compensation given the purposive interpretation to that statute. The respondent argued that the said Act of 2006 was intended to restrict the category of claimants of awards by introducing specified category of tests and thus, the appellant was not entitled for an award of compensation.

Mr. Justice Bernard J. Barton dismissed the appeal of the appellant. The Court held that a plain, ordinary and natural meaning to the said s. (1A) (a) (i) of the Act of 2006 would reveal that the legislature intended to award compensation to those claimants who had been detected Hepatitis C positive based on a result arising from an enzyme-linked immunosorbent assay. The Court rejected the contention of the appellant that the said statute of 2006 should operate retrospectively to include the results of the ChLIA test, which was not an enzyme-linked immunosorbent assay. The Court found that the legislature expressly applied the provisions of the said Act of 2006 retrospectively and awarded compensation to the claimants based on the tests carried out before the date on which the Act of 2006 came into force. The Court, however, observed that the appellant, despite being granted time to file her claim, did not file the same until 2008, by which time, the ChLIA test, as conducted on the specimen of the appellant, would no longer meet the qualifying criteria as set out under s. (1A) (a) (i) of the Act of 2006. The Court held that it should lean to interpret any statute by giving it a plain and natural meaning and resort to ascribe other meanings only when the plain meaning was obscure or ambiguous.

JUDGMENT of Mr. Justice Bernard J. Barton delivered on the 19th day of July 2016
1

These Proceedings come before the Court by way of an Appeal from a decision of the Hepatitis C Tribunal delivered the 6th October, 2015 whereby her Application for compensation was refused on the grounds that the Appellant had failed to establish a fundamental prerequisite of proof, namely that she had been diagnosed positive for Hepatitis C within the meaning of s. (1A) (a) (i) of the Hepatitis C Compensation Tribunal (Amendment) Act 2006 (the 2006 Act).

2

The net issue which arises for determination on the Appeal is whether the positive test results for Hepatitis C on a specimen of the Appellant's blood carried out on the 7th 8th and 9th of January 1998 satisfy the requirements of the section.

Background
3

The Appellant was born on 16th March, 1971. She was married in 1991 and has three children, all boys. Her second son was born on the 27th October, 1993 at Portlaoise General Hospital. The Appellant's blood had tested rhesus negative, the blood of her first baby had tested rhesus positive; consequently she was treated with Anti-D Immunoglobulin (Anti-D) after the birth of each of her children. The Anti-D administered after the birth of her second child came from a batch which was subsequently indentified as being potentially infectious for the Hepatitis C virus (HCV).

4

By letter dated 9th June, 2008, the Irish Blood Transfusion Service Board, (BTSB) wrote to the Appellant's solicitor confirming that the likely batch of Anti- D which would have been in circulation at Portlaoise in 1993 was batch number 610. Two recipients of Anti-D from that batch had tested positive for HCV antibodies and Polymerase Chain Reaction (PCR) positive for the virus but each had other significant risk factors for HCV; one of these had also received Anti-D from batch 615 which was known to be weakly infectious. Four others, including the Appellant, had tested positive on what the BTSB mistakenly described at the time as an “ELISA” test but which subsequently tested negative on the “RIBA 3” test.

5

On the 6th January, 1998, the Appellant gave a blood donation. All blood donations are routinely screened by the BTSB laboratory for the presence of human immunodeficiency virus (HIV), Hepatitis B virus (HBV) and HCV antibodies. The method of test used to test by the BTSB to test the Appellant's specimen was the Abbott Prism test, which is an in vitro chemiluminescent immunoassay (“ChLIA”) for the detection of antibodies to HCV in human serum and plasma.

6

The “ChLIA” tests were reported positive. A PCR test was also carried out to determine whether the virus was still active. It was reported negative.

7

Following best practice clinical guidelines, the BTSB, in common with other blood transfusion services, has a protocol in place which provides for confirmatory testing of any specimen testing positive on the “ChLIA”. That service is provided by the National Virus Reference Laboratory (NVRL), Department of Microbiology, at U.C.D.

8

Different methods of confirmatory testing for HCV antibodies were and are utilised by the NVRL, namely, the Ortho EIA developed by Ortho Diagnostics, the Abbott Axsym, developed by Abbott Industries – both of which are Enzyme Linked Immunosorbent assays, (otherwise known as “ELISA” tests) – and the Recombinant Immuno-blot antibody assay (“RIBA 3”) which is an Immuno-blot assay. Although the Appellant's specimen had tested “ChLIA” positive, the NVRL reported on the 20th January, 1998, that the specimen had tested negative using these methods.

9

All of the Immunoassays used to test the Appellant's blood sample are classified as 3rd generation anti-HCV assays. They are based on the same principals of antibodies binding to antigens – in other words, they share the same structure and are designed to detect the reaction between an antibody and an antigen. However, they differ on the precise mechanism by which the binding of an antibody to an antigen is detected and communicated, the essence of which is the form of the marker used to identify and deliver the result of the test. It is pertinent to refer to the respective mechanisms in turn.

10

A Radio-Immuno Assay (RIA) uses a radioactive molecule which is read by a Geiger counter. An “ELISA” involves the use of an enzyme to which a substrate for that enzyme will be added which, in the presence of the enzyme, will change colour and is then detected by measuring the optical density of the solution. A “ChLIA” involves adding a substance such as hydrogen peroxide which records the emission of light that can be measured in a chemi-luminometer.

11

Whether the immunoassay is an “RIA”, an “ELISA” or a “ChLIA”, they all work on exactly the same principle; the only difference being the type of marker conjugate and, consequently, the different type of signal – whether radioactivity, colour change, or light emission – which is generated. It is the binding of the conjugate, whether an enzyme or chemiluminescent substance, to the antibody which generates the signal which can then be read.

12

The results of all tests on the Appellant's specimen were communicated to her by letter dated 27th April, 1998. She was advised that whilst her sample of blood had tested reactive in one of the screening tests, those results were not confirmed by subsequent testing. Notwithstanding, under the guidelines then applicable, she was also advised that the BTSB would not be in a position to use her donations because her blood had shown a reaction, albeit on the “ChLIA” only.

13

On the 13th January, 1999, the BTSB again wrote to the Appellant making reference to the letter of the 27th April advising that, while she had tested “ELISA” positive, she had also tested “RIBA” negative and that therefore the initial result was considered to be a false positive reaction.

14

It is quite clear from the papers before the Court that references in the letter to the Appellant having tested “ELISA” positive were factually incorrect; it was the “ChLIA” rather than the “ELISA” tests which had tested positive. The error was repeated in other documentation, including a letter from Dr. Eimear Lawlor dated 11th August, 1999, which begs a question: what was the understanding of the BTSB and its medical staff concerning the differences between the tests used to screen and, if found positive, to confirm the presence of HCV in a specimen.

15

It was submitted on behalf of the Appellant that this was significant for a number of reasons, not least of which was that not only was the BTSB using these terms interchangeably, but so too were its highly qualified...

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