The High Court has refused a request by a child bringing a personal-injury action to require GlaxoSmithKline Biologicals S.A. to answer a written question about whether it compared adverse-event reports for two swine flu vaccines.
The application concerned one proposed interrogatory, or written question, in proceedings brought by Benjamin Blackwell, a minor suing through his mother and next friend, Natalie Blackwell. The claim alleges that he developed narcolepsy and cataplexy after receiving Pandemrix at Ratoath National School on 22 February 2010, aged five. The allegations in the underlying case remain disputed and were not decided in this application.
The proposed question asked whether the fourth defendant had analysed an alleged disparity in adverse events associated with Pandemrix and Arepanrix, said to be evident in its Enhanced Safety Review Team reports for a specified period in late 2009 and early 2010. The plaintiff argued that an answer could clarify what the company knew and potentially reduce trial costs.
GlaxoSmithKline disputed the premise that the reports established a meaningful disparity and objected that the question was unclear, bundled several issues together and sought a response on matters central to the case. In an affidavit, its senior pharmacovigilance director said the company had conducted appropriate analysis, but rejected the suggested characterisation of the data and said comparative analysis of week-by-week reports was scientifically invalid. Those positions were submissions and affidavit evidence considered on this application, not findings on the underlying claim.
Mr Justice MacGrath held that the proposed question assumed a disputed conclusion and raised several questions, including whether a disparity existed and whether it was apparent from the reports. He was not satisfied that it was clear or capable of a clear answer. He also considered that requiring an affidavit response risked unfairness to the company on an issue central to the proceedings.
The judge said the disputed matters could be addressed through oral evidence and cross-examination at the trial. He also considered discovery from a separate, since-compromised case, which the parties had agreed would be treated as discovery in these proceedings, and an affidavit by solicitor Roderick Bourke addressing other agreed discovery issues. The court noted that the disputed interrogatory had not been covered by that affidavit.
The court refused leave to deliver the interrogatory, finding it had not been shown to be necessary for the fair disposal of the case or for saving costs. It also declined to reformulate the question. The ruling determined only this procedural application; it did not decide the injury claim or the disputed vaccine-safety issues.