Bailey & Ors v Glaxosmithkline (UK) Ltd

In group litigation, the scope of a trial is governed by the pleaded case and the issues defined by the Group Litigation Order. A party cannot expand that scope shortly before trial by advancing a materially different case, particularly where an earlier substantive ruling allowed the proceedings to continue on a defined basis and expansion would cause prejudice.

Where the parties agree that a topic is outside the trial issues, the court need not determine its legal merits. Evidence may address matters necessary to establish the pleaded comparative case, but material directed to unpleaded issues or irrelevant alleged conduct may be excluded or redacted.

The claimants brought proceedings under the Consumer Protection Act 1987, alleging that Seroxat was defective because withdrawal effects were worse than those associated with other selective serotonin reuptake inhibitors and should have been disclosed in the product literature.

Before trial, the claimants sought to clarify that their case also included a freestanding defect based on the incidence, severity and duration of withdrawal effects, irrespective of comparison with other drugs. The parties also addressed the relevance of Seroxat’s general risk-benefit profile, the list of trial issues, the addition of a further lead case and the admissibility of expert material.

1. Scope of the defect case. The claimants’ case was restricted to the comparative, or “worst in class”, withdrawal allegation and the associated failure-to-warn allegation. The pleaded case and the Group Litigation Order did not include a freestanding allegation that withdrawal effects were defective solely because of their incidence, severity or duration.
2. The earlier rulings of Foskett J were not merely ordinary case-management decisions. They permitted the litigation to proceed after a lengthy hiatus on the basis of the case advanced when the proceedings were stayed. The court should therefore be slow to expand that case shortly before trial, especially where expansion would prejudice the defendant by requiring investigation of a broader case.
3. Risk and benefit evidence. No application requiring a ruling on the legal merits of the holistic risk-benefit approach was before the court. Both parties agreed that the topic was outside the trial scope, and it was too late to expand the trial to include it. The defendant was not required to plead a positive case on benefits because the claimants had expressly stated that benefits were immaterial to their pleaded case.
4. The claimants remained entitled to examine the nature, incidence and duration of withdrawal effects insofar as those matters were necessary to determine the pleaded comparative case. The defendant’s list of issues would stand.
5. The claimant’s application to add Mr Holmes as an additional lead case was allowed, resulting in five lead cases. Specified passages in Professor Healy’s joint note were ordered to be redacted because they went beyond relevant study-related criticism, impugned the defendant’s conduct and raised factual issues outside the trial.