The High Court has ordered Baxter to disclose certain records in a personal injuries case brought by Jennifer Walsh, who alleges that a Celvaplan swine flu vaccine caused an inflammatory eye condition. The ruling concerns discovery only; it does not decide whether the vaccine caused her condition or whether any defendant was negligent.
Mr Justice Max Barrett delivered the judgment on 19 June 2017. The case concerns a discovery application in proceedings against the Health Service Executive, Baxter AG and Baxter Healthcare Limited. The judgment records Ms Walsh’s claim that she received vaccine doses on 21 December 2009 and 25 January 2010, after which she experienced eye irritation, redness and watering and required continuing care from a consultant ophthalmic surgeon. Baxter denied negligence and that the product was defective.
The court ordered discovery of periodic safety update reports and simplified periodic safety update reports for Celvaplan, limited to material relevant to the eye condition and to the period from 6 October 2009 to 10 August 2010. It also ordered discovery of Celvaplan packaging for two specified batches, VNV9J020A and VNV9J016A. A further category of documents had been agreed by the parties; the judgment does not detail its contents.
The judge refused a broader request for records of complaints and reports about a range of possible adverse effects, finding that the request was not sufficiently limited by time or to documents relevant to Ms Walsh’s alleged injury. He also refused a request for all research, testing, clinical-trial and pre-release surveillance material. The court said that safety reports to be disclosed, published regulatory assessments and the vaccine’s regulatory history provided relevant information, and considered the broader request unnecessary for fair disposal of the case.
The court declined to order disclosure of Baxter’s regulatory application files, which it described as containing commercially confidential information, but directed Baxter to identify relevant publicly available reports and where they could be found online, if online. It refused a separate request for all post-release pharmacovigilance and surveillance records, saying the relevant material was covered by the safety-report category or publicly available documents. It also refused a request for correspondence between the HSE and Baxter about administration guidance and vaccine batches, finding it duplicated the packaging category.
Baxter had asked for a confidentiality agreement as a condition of discovery. The judge declined to let Baxter determine the terms and said the court would hear further submissions on confidentiality after the parties considered the judgment and before any order issued. The judgment therefore settled the discovery categories described above but left confidentiality arrangements for later consideration.