Bailey & Ors v Glaxosmithkline (UK) Ltd

In group litigation, a party may not expand its case at trial beyond issues fixed by unappealed case-management rulings and an ordered list of issues. That remains so where the proposed expansion is said to arise from the pleadings or from the opponent’s failure to plead a positive case. Introducing a relative risks-and-benefits case for a prescription medicine, after the case had been confined to comparative discontinuation symptoms, would require a new factual and expert inquiry and cause procedural unfairness. The opponent’s failure to plead particular benefits did not amount to a concession that no such benefits existed. The appeal was dismissed.

The claimants in the Seroxat Group Litigation alleged that Seroxat was defective under Consumer Protection Act 1987 because discontinuation symptoms made withdrawal more difficult than with other SSRIs. Lambert J held in the High Court that the pleaded and case-managed issue was confined to that “worst in class” case and excluded a wider comparison of relative risks and benefits: [2019] EWHC 1167 (QB). The claimants appealed, arguing that the pleadings and the defendant’s Defence permitted them to contend that Seroxat had no particular relative benefits. The central issue was whether that wider case could be introduced in opening at a trial whose scope had been fixed by earlier, unappealed rulings.

Appeal dismissed. Hamblen LJ gave the leading judgment. Lord Justice Peter Jackson and Sir Ernest Ryder, Senior President of Tribunals, agreed.

1. Effect of prior rulings. Foskett J had defined the claim as a “worst in class” case concerning discontinuation symptoms and had ruled that it was too late to expand it into a general risks-and-benefits case: [2017] EWHC 377 (QB). Lambert J subsequently ruled that relative benefits would not feature at trial and ordered that the defined list of issues would govern the trial: [2019] EWHC 337 (QB). Those decisions were fundamental case-management decisions and were not appealed.
2. No expansion at trial. Once the court had identified and fixed the issues for trial, it was impermissible to introduce a materially wider case in opening by relying on pleading points or an assumed “level playing field”. A relative risks-and-benefits case would require a wide-ranging factual and expert inquiry which had not been undertaken. Allowing it would cause obvious unfairness to the defendant and undermine active case management.
3. Pleadings. In any event, the court agreed that neither party had pleaded a positive risks-and-benefits case. The defendant was not required to plead particular relative benefits merely because it challenged the claimants’ limited approach. Its pleading that there was no basis for distinguishing Seroxat from other SSRIs in efficacy or the nature of adverse reactions did not concede that Seroxat had no relative benefits. The claimants’ case remained limited to comparative discontinuation symptoms.
4. Substantive defect law. The court recorded the statutory framework in Consumer Protection Act 1987, including the guidance in Wilkes that product safety involves a holistic assessment of all the circumstances and, for medicinal products, may require risks to be balanced against potential benefits. It did not need to determine the substantive merits of that approach because the appeal was resolved on the scope of the trial.

• Court of Appeal (Civil Division). Hamblen LJ, with whom Lord Justice Peter Jackson and Sir Ernest Ryder agreed, dismissed the appeal: [2019] EWCA Civ 1924.
• High Court of Justice, Queen’s Bench Division. Lambert J held that the claimants’ case was confined to the comparative discontinuation-symptoms case and that a wider relative risks-and-benefits case could not be introduced: [2019] EWHC 1167 (QB).