High Court: Further submissions to be heard on proposed confidentiality agreement in vaccine personal injury case

About this case:

• Judgment:
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Declining to order discovery of all but one of the categories sought, Mr Justice Max Barrett added that he would hear further submissions on the pharmaceutical company’s “somewhat unusual” request for the Court to order that the plaintiff enter into a confidentiality agreement regarding the discovery so made.

Background

In December 2009, Ms Jennifer Walsh was administered a dose of swine flu vaccine ‘Celvaplan’.

Thereafter, Ms Walsh claimed 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.

Consequently, Ms Walsh commenced personal injuries proceedings, in the context of which she brought a discovery application to the High Court.

Ms Walsh’s case against Baxter AG and Baxter Healthcare Limited was that Baxter failed:

Discovery ‘check-list’

Justice Barrett was satisfied that in the interests of consistency, efficiency and predictability; it was possible to reduce the principles identified in Framus v. CRH plc 2 IR 20 to a ‘check-list’ of questions:

(1) Has the party seeking discovery pinpointed, i.e. identified with great accuracy or precision, the documents or category of documents required?

(2) Has the party seeking discovery given good reason why the pinpointed documents or category of documents are required?

(3) Are the documents sought on discovery relevant, directly or indirectly, to the matter in issue between the parties in the proceedings?

(4) Has the party seeking discovery shown it is reasonable for the court to suppose that the documents contain information which may enable the applicant either to advance his own case or damage the case of his adversary?

(5) Has the applicant for discovery avoided the following in respect of each document or category of discovery required:

(i) mere speculation;

(ii) what has been traditionally characterised as a ‘fishing expedition’;

(iii) seeking discovery merely to find out whether documentation may be relevant;

(iv) seeking a general trawl through the other party’s documentation;

(v) utilising the discovery process as a tactic in the battle between the parties?

(6) Is discovery of the document or category of documents required necessary for disposing fairly of the cause or matter or for saving costs?

(7) Discovery of any document or category of documents that reaches this point ought generally to be ordered. Limitation may be imposed by the court where it would be oppressive to produce them all; and/or there is a want of proportionality.

Categories of Documentation Sought

Category 1 - All documentation in relation to complaints and other reports or notifications regarding adverse effects related to the vaccine, in the possession of Baxter.

Justice Barret was not satisfied that Ms Walsh had imposed any temporal limitation on Category 1, nor had she limited her request to documents relevant to her alleged injury.

Declining the discovery sought, and limiting the discovery to that which had been offered by Baxter, Justice Barrett described the discovery sought to be a “widespread and general trawl”.

Category 2 - All documentation in relation to warnings, disclaimers and/or potential side-effects of the vaccine which were issued to the HSE and others.

Justice Barrett was satisfied that this category satisfied all elements of the check-list above, and therefore ordered the discovery as sought.

Category 3 - All documentation in relation to research, testing, clinical trials (including details of all phases) and post-marketing surveillance performed by or on behalf of Baxter prior to the release of the vaccine.

Declining to make an order for the discovery sought, notwithstanding answering ‘yes’ to Questions (1)-(5); the answer to Question (6) had to be ‘no’.

Celvaplan had all necessary regulatory approvals required under European Union.

Category 4 - All documentation in relation to the licensing and/or granting of the MA and release of the vaccine submitted to the European Medicines Agency and/or the Irish Medicines Board

Declining to make an order for the discovery sought, notwithstanding answering ‘yes’ to Questions (1)-(5); the answer to Question (6) had to be ‘no’.

However, the Court did order that Baxter specify the publicly available reports that contain the data relevant to Ms Walsh’s claim and where they are available

Category 5 - All documentation in relation to pharmacovigilance and post-marketing surveillance subsequent to the release of the vaccine.

Again, declining to make an order for the discovery sought, notwithstanding answering ‘yes’ to Questions (1)-(5); the answer to Question (6) had to be ‘no’.

Category 6 - had already been agreed between the parties prior to the hearing.

Category 7 - All documentation passing between the HSE and Baxter in relation to the guidance for use and/or administration of the vaccine and the vaccine batches.

Justice Barrett held that this was a duplication of category 2 and declined to make an order for discovery.

Confidentiality

Baxter claimed that the documentation sought contained commercially confidential information, the disclosure of which could harm their competitive position – and therefore sought the Court to order the plaintiff to enter into a confidentiality agreement.

Justice Barrett stated that the Court was not disposed to ‘out-source’ the policing of confidentiality so that discovery is made of documents on such terms as Baxter may determine to be acceptable.

On this point, Justice Barrett stated that the Court would hear further submissions on this somewhat unusual request.