Blackwell v The Minister for Health and Children

• Jurisdiction: Ireland
• Judge: Mr. Justice MacGrath
• Judgment Date: 18 August 2020
• Neutral Citation: [2020] IEHC 427
• Docket Number: [2017 No. 9907 P.]
• Court: High Court
• Date: 18 August 2020

BETWEEN

BENJAMIN BLACKWELL A MINOR SUING BY HIS MOTHER AND NEXT FRIEND NATALIE BLACKWELL

PLAINTIFF

AND

THE MINISTER FOR HEALTH AND CHILDREN, THE HEALTH SERVICE EXECUTIVE, THE HEALTH PRODUCTS REGULATORY AUTHORITY

AND

GLAXOSMITHKLINE BIOLOGICALS S.A.

DEFENDANTS

[2020] IEHC 427

MacGrath J.

[2017 No. 9907 P.]

THE HIGH COURT

Interrogatories – Personal injuries – Breach of the provisions of the Liability for Defective Products Act 1991 – Plaintiff seeking leave to deliver interrogatories for examination of the fourth defendant – Whether injustice would be occasioned to the plaintiff by the refusal to grant leave to deliver the interrogatory

Facts: The plaintiff, Mr Blackwell, applied to the High Court for an order pursuant to O. 31, r. 1 of the Rules of the Superior Courts granting him leave to deliver interrogatories for examination of the fourth defendant, GlaxoSmithKline Biologicals SA. In the underlying proceedings, the plaintiff claimed damages for personal injuries allegedly arising in consequence of the administration to him of the swine flu vaccine, Pandemrix on the 22nd February, 2010 at Ratoath National School when he was aged five. It was alleged that he developed symptoms of excessive sleepiness and was subsequently diagnosed with narcolepsy and cataplexy. He alleged negligence, breach of duty, breach of his constitutional rights and breach of the provisions of the Liability for Defective Products Act 1991. It was pleaded, inter alia, that the fourth defendant was in breach of the provisions of the 1991 Act in failing to give adequate warnings of the increased incidences of adverse events associated with Pandemrix compared to its other flu vaccines. Pandemrix was developed by the fourth defendant in response to the human swine flu in 2009 and was produced at its Dresden plant in Germany. It was alleged that another swine flu vaccine, Arepanrix, which was produced by the fourth defendant at its plant in Canada, had far fewer adverse reactions than Pandemrix. Pandemrix was used in Ireland and other European countries. Arepanrix was used in Canada. The application was brought by way of notice of motion dated 28th February, 2020. Initially, six interrogatories were raised on behalf of the plaintiff for the examination of the first and second defendants, the Minister for Health and Children and the Health Service Executive, and the fourth defendant. The parties came to an agreement in relation to all but one which was addressed to the fourth defendant being: “Did not the fourth defendant conduct an analysis of the disparity in adverse events associated with the Pandemrix and Arepanrix vaccines respectably, which was evident from its Enhanced Safety Review Team Reports for the period from week 46 of 2009 (4-10 November) to week 6 of 2010 (3-10 February).”

Held by MacGrath J that the manner in which the interrogatory was phrased sought the acceptance of a conclusion, whether directly or indirectly, of a disputed premise, namely the suggested disparity. It also raised a number of issues and MacGrath J was not satisfied that it had the clarity required or that it was such as to be capable of a clear answer. He was also satisfied that, given the manner in which the interrogatory was phrased, there was a possibility that the fourth defendant could be prejudiced by being fixed with a response on affidavit to a matter which was central to an issue in the proceedings. In this regard, the court had regard to the contents of Dr Seifert’s affidavit and the objections raised by him therein. It also seemed to MacGrath J that no injustice would be occasioned to the plaintiff by the refusal to grant leave to deliver the interrogatory.

MacGrath J held that he would refuse the relief claimed.

Application refused.

JUDGMENT of Mr. Justice MacGrath delivered on the 18th day of August, 2020

The Application

1 This is the plaintiff's application for an order pursuant to O. 31, r. 1 of the Rules of the Superior Courts granting him leave to deliver interrogatories for examination of the fourth named defendant.

2 In the underlying proceedings, the plaintiff claims damages for personal injuries allegedly arising in consequence of the administration to him of the swine flu vaccine, Pandemrix on the 22nd February, 2010 at Ratoath National School when he was aged five. It is alleged that he developed symptoms of excessive sleepiness and was subsequently diagnosed with narcolepsy and cataplexy. He alleges negligence, breach of duty, breach of his constitutional rights and breach of the provisions of the Liability for Defective Products Act, 1991 (“the Act of 1991”). It is pleaded, inter alia, that the fourth named defendant was in breach of the provisions of the Act of 1991 in failing to give adequate warnings of the increased incidences of adverse events associated with Pandemrix compared to its other flu vaccines. Pandemrix was developed by the fourth named defendant in response to the human swine flu in 2009 and was produced at its Dresden plant in Germany. Of particular relevance to this application is an allegation that another swine flu vaccine, Arepanrix, which was produced by the fourth named defendant at its plant in Canada, had far fewer adverse reactions than Pandemrix. Pandemrix was used in Ireland and other European countries. Arepanrix was used in Canada.

3 The application is brought by way of notice of motion dated 28th February, 2020. Initially, six interrogatories were raised on behalf of the plaintiff for the examination of the first, second and fourth named defendants. The parties have come to an agreement in relation to all but one which is addressed to the fourth named defendant being:-

“Did not the fourth defendant conduct an analysis of the disparity in adverse events associated with the Pandemrix and Arepanrix vaccines respectably, which was evident from its Enhanced Safety Review Team Reports for the period from week 46 of 2009 (4-10 November) to week 6 of 2010 (3-10 February).”

4 The plaintiff claims that prior to his vaccination the fourth named defendant was aware of the risks associated with the use of the vaccine including those revealed by post marketing pharmacovigilance data which, it is alleged and contended showed that the Pandemrix vaccine was significantly less safe than the alternative H1N1 vaccines. It is contended that a disparity was evident from the pharmacovigilance data produced by the fourth named defendant from November, 2009 to the date of the plaintiff's vaccination on 22nd February, 2010. It is alleged that the fourth named defendant, as the market authorisation holder of the product, failed in its obligations to notify the appropriate authority of a disparity in the incidents of adverse events between Pandemrix and Arepanrix. The authority is the European Medicines Agency (“EMA”) which authorised Pandemrix for use in Ireland. It is alleged that the fourth named defendant was in breach of its obligations under EU law including Regulation 726/2004, regarding procedures for the authorisation and supervision of medicinal products for human and veterinary use arising from the alleged failure to notify the EMA of the pharmacovigilance data; and that the fourth named defendant was in breach of its duty to share ongoing pharmacovigilance data which, it is further alleged, was breached by the fourth named defendant acquiescing in what is described as a system of disinformation which was adopted by the first and second named defendants. The first and second named defendants are not parties to this application. All matters are in dispute and these allegations are denied by the fourth named defendant.

Affidavit in Response to Request for Discovery

5 This is one of a number of proceedings brought by plaintiffs in which somewhat similar complaints are made. In Aoife Bennett v. Minister for Health and Children, HSE, GlaxoSmithKline Biologicals SA and Health Products Regulatory Authority (Record No. 2012/ 12009P) (the “Bennett proceedings”), extensive discovery was made. The Bennett proceedings have since been compromised. Following the conclusion of the trial in the Bennett matter, a number of motions were issued in these proceedings, relating to discovery and this application for leave to deliver interrogatories. Counsel for the plaintiff, Mr. Kilfeather S.C., explained to the court that the obligations of the fourth defendant as the market authorisation holder are the subject of more significant focus than they were in the Bennett proceedings. He also informed the court that in the discovery application, the plaintiff sought documents relating, inter alia, to the roles and involvement of two teams within the fourth named defendant company and as to what protocols were in existence. It is explained that in the context of the ongoing requirement to monitor data received following the administration of the vaccine, information was fed and collated in the fourth named defendant's global database, known as the OCEANS database, which held details of adverse events reported to the fourth defendant for each of its products.

6 In the context of discussions regarding the making of discovery, the parties agreed that an affidavit be sworn on behalf of the fourth defendant in which explanations and answers be provided in respect of a number of matters, including the role of the two teams, and concerning applicable and existing rules and protocols. It was also agreed that documentation supporting the answers would be exhibited. This affidavit was prepared and sworn by Mr. Roderick Bourke, solicitor and partner in the firm McCann FitzGerald on 12th May, 2020. Although not now on record for the fourth defendant in these proceedings, Mr. Bourke's firm have advised the fourth defendant in respect of litigation surrounding Pandemrix since 2012 and assisted in the preparation of discovery in the Bennett proceedings.

7 Mr. Bourke explains that in...