Bailey & Ors v Glaxosmithkline (UK) Ltd

A claimant must litigate the case disclosed by the pleadings and cannot expand it at trial by recasting the alleged defect. Where the pleaded case excludes consideration of relative benefits, the claimant cannot invite the court to assume a level playing field of risks and benefits between comparator products. A defendant’s decision not to plead a positive case on benefits does not concede that no such benefits exist. Any amendment required to introduce a wider risk-benefit case may be refused where the litigation has long proceeded on defined issues and late amendment would cause unfairness.

This was an interlocutory ruling in a long-running group action concerning whether Seroxat was defective under the Consumer Protection Act 1987. The claimants’ pleaded case alleged that Seroxat caused discontinuation symptoms to a greater extent than other SSRIs. Earlier case-management rulings had confined the action to that comparative allegation and excluded relative benefits from the issues for trial.

In opening the trial, the claimants sought to argue that the court should assume no relative benefits over comparator drugs and assess the alleged risks on a level-playing-field basis. The issue was whether that submission fell within the pleaded case.

1. Scope of the pleaded case. The claimants’ case was confined to the allegation that Seroxat was worse than other SSRIs in respect of discontinuation symptoms. It did not include a holistic comparison of the relative risks and benefits of the drugs. The claimants’ response to a request for further information expressly stated that relative benefits were not material to their case.
2. No concession by the defendant. The defendant was entitled to meet the claim as pleaded and was not required to advance a positive case identifying Seroxat’s relative benefits. Its failure to do so did not amount to a concession that no such benefits existed. The admission concerning efficacy was limited to therapeutic efficacy for licensed indications and did not establish the absence of other relative benefits.
3. Effect of earlier rulings. Foskett J had carefully analysed and defined the case in [2016] EWHC 178 (QB) and [2017] EWHC 377 (QB). Those rulings had not been appealed. The claim therefore had to proceed on the basis of the existing pleadings and the defined issues.
4. Disposition. The claimants were not entitled to argue that Seroxat had no relative benefits or that there was a level playing field of relative risks and benefits. There was no application to amend the Particulars of Claim. Had one been made, permission would have been refused as too late and unfair to the defendant. The judge did not determine the substantive merits of the defendant’s legal challenge under section 3.

First-instance interlocutory ruling. The judgment records that the earlier case-management rulings were not appealed.