Walsh -v- The Health Service Executive & ors, [2017] IEHC 394 (2017)

Party Name:Walsh, The Health Service Executive & ors
Docket Number:2012 5061 P
 
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THE HIGH COURT2012 No. 5061P

BETWEEN:

JENNIFER WALSHPlaintiff– and –

THE HEALTH SERVICE EXECUTIVE, BAXTER AG AND

BAXTER HEALTHCARE LIMITEDDefendants

JUDGMENT of Mr Justice Max Barrett delivered on 19th June, 2017.

  1. Background1. It appears that in December, 2009, Ms Walsh was administered a dose of swine flu vaccine which retails under the trade-name ‘Celvaplan’. Thereafter, Ms Walsh claims to have suffered irritation and redness of the eyes and weeping eyes, and to have been diagnosed with an inflammatory ocular condition that requires continuing care by a consultant ophthalmic surgeon. As a consequence of the foregoing, Ms Walsh has commenced the within personal injuries proceedings, in the context of which she has brought the discovery application that is now before the court. So far as Ms Walsh’s case against the Baxter parties (hereafter ‘Baxter’) is concerned, it appears to comprise the following allegations, viz. that Baxter failed (i) to test adequately, or at all, the vaccine prior to its release, (ii) to warn Ms Walsh adequately or at all of the risks (and the absence of adequate testing of the vaccine) prior to administration, and (iii) to warn Ms Walsh of the risks inherent with Celvaplan.

  2. An Aside on Celvaplan2. Among the affidavits sworn as part of the within affidavit application, the court has been supplied with an affidavit sworn by Ms C. Christle, a solicitor acting for the Baxter parties, in which, inter alia, Ms Christle sets out a brief summary of the regulatory framework under which Celvaplan was granted a marketing authorisation by the European Commission on application by Baxter through what is known as the ‘centralised procedure’. It is informative and helpful to recount at this juncture the details supplied by Ms Christle:

    “Celvaplan H1N1 was licensed on the basis of a pandemic ‘mock-up vaccine concept, based on European Guideline EMEA/CPMP/VEG/4717/2003 which allows for the submission and approval of a core pandemic dossier during non-pandemic periods. When a pandemic is subsequently declared, the procedure allows for fast-track approval of a pandemic variation. A mock-up licence can only be granted after a pandemic has been declared and the pandemic variation has been approved. Baxter’s initial application for a Marketing Authorisation(‘MA’) for Celvaplan through the centralised procedure was first supported by a core dossier for pandemic influenza vaccine H5N1. On 4 March 2009, the European Commission issued an MA under exceptional circumstances for the HFN1 mock-up vaccine of Celvaplan.

    On 11 June 2009, the World health Organisation (‘WHO’) declared a ‘Phase 6’ official influenza pandemic, reflecting the global spread of a new strain of human flu virus H1N1. On 22 September 2009, following the onset of the pandemic and WHO declaration, Baxter filed a formal Pandemic Variation to update the composition of the strain to H1N1 and updated the Quality Documentation sections which were product specific to H1N1 as opposed to the previous H5N1.

    On 1 October 2008, the European Committee for Medicinal Products for Human Use (‘CHMP’) adopted a Positive Opinion to change the pandemic strain vaccine to H1N1 and the European Commission Decision was subsequently issued on 6 October 2009. There was no requirement to provide H1N1 specific clinical data prior to variation approval. H1N1 specific clinical data was collected in children, adults and the elderly during the pandemic.

    In April 2010 the CHMP reviewed further information on the centrally authorised pandemic influenza vaccines Celvaplan, Feocetria and Pandemrix and concluded that data from post-marketing surveillance of 40 million people since September 2009 was sufficient to allow al three vaccines to be used outside a declared influenza pandemic. On 12 August 2010 the European Commission issued a modification of the original MA to a full MA in light of the positive data on the clinical efficacy and safety of Celvaplan.

    On 10 August 2010, the WHO announced that the influenza pandemic was over and the H1N1 2009 pandemic entered its post-pandemic phase. Pharmacovigilance/adverse events updates which had been published regularly by the European Medicines Agency since December 2009 ended on 8 August 2010. The Agency undertook to publish any changes to MAs into the future.

    The most recent opinion in relation to Celvaplan issued by the CHMP on 26 February 2015 based on a review of available information stated that the quality, safety, and efficacy of Celvaplan continues to be adequately and sufficiently demonstrated and that the benefit/risk profile of this medicinal product continues to be favourable. The CHMP recommended that the renewal of the MA be granted with unlimited validity. The MA for Celvaplan was renewed by the European Commission on 6 May 2015. Baxter AG is no longer the MA holder for Celvaplan.”

    1. The court does not understand any of the above-quoted averments to be disputed.

  3. The Decision in

    Framus4. There is no disagreement between the parties to the within proceedings as to the general legal principles applicable to discovery. Even so, it seems to the court that it is helpful to commence its judgment by considering in some detail the principles of discovery outlined by Murray J., for the Supreme Court, in Framus v. CRH plc [2004] 2 IR 20 (paras.26–36), to which reference was made in the course of the hearing and which the court has found helpful in adjudging upon the within application. Those principles might be summarised as follows:

    1. Party Seeking Discovery

      (1) A party seeking discovery must pinpoint the documents or category of documents required.

      (2) A party seeking discovery must give reasons why the pinpointed documents or category of documents are required.

      (3) Blanket discovery requests are not allowed.

      (4) Documents sought on discovery must be relevant, directly or indirectly, to the matter in issue between the parties in the proceedings.

      (5) A party seeking discovery must show it is reasonable for the court to suppose that the documents contain information which may enable the applicant to advance his own case or to damage the case of his adversary.

      (6) A party seeking discovery cannot obtain discovery based on (a) mere speculation or (b) what has been traditionally characterised as a ‘fishing expedition.’ [1]

      [1] The phrase ‘fishing expedition’, though commonly used, is not especially informative. If objection to discovery is to be made on grounds of want of relevance and/or necessity and/or proportionality and/or some other ground, e.g. that what is being sought is a speculative exercise, it would seem preferable that the objection be raised precisely and not by way of nebulous metaphor, in order that a court might engage with the precise difficulty(ies) claimed to present. However, the phrase ‘fishing expedition’ has passed into common usage; this being so, as good a definition as to any as to what it seems generally intended to embrace is to be found in the judgment of Kerr L.J. in In Re State of Norway’s Application [1987] QB 433, 482:

      “The Solicitor-General stated: ‘Although Freshfields have attempted to explain...

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