This case relates to an action for damages brought by a group of Claimants funded by the Legal Services Commission (LSC) in 2007, arising from their use of a prescription-only antidepressant drug, Seroxat. Seroxat was alleged to be defective within the meaning of section 3 of the CPA because of a single aspect of its adverse event profile, namely symptoms upon discontinuation. The Claimants alleged that Seroxat was "worst in class" for discontinuation symptoms when compared with other drugs in the comparator class. In a Request for Information prior to filing its Defence, GSK asked whether the benefits of the product were material to be taken into account. The Claimants responded that they were not. Accordingly, GSK's Defence asserted firmly that it was not appropriate to assess defect by reference to one characteristic of a product only, and that all relative risks and benefits should be taken into account in that assessment.
Shortly before trial of the claims was due to commence in 2011, the LSC withdrew its funding on receipt of advice by the Claimants' then leading Counsel on the merits of the claim. There was a lengthy stay of proceedings before the Claimants revived the claims in 2015, having obtained the benefit of private funding provided by Managed Legal Solutions (MLS).
The litigation then formed the subject of a series of hearings before case management judge, Foskett J, and later before trial judge, Lambert J. In particular, Foskett J ruled in a judgment dated 1 March 2017 that the characterisation of the Claimants' case as "worst in class" was an accurate one, and that it was too late for the Claimants to (if they were planning to do so) engage in a risk/benefit analysis, which they had previously "expressly disavowed". By this time the judgment in Wilkes had also been handed down, which supported GSK's position that the approach to defect should be a holistic one.
A pre-trial review was later conducted before Lambert J in February 2019, at which time the Claimants sought to argue a 'free-standing defect' case, i.e. that Seroxat was defective because of its effects on discontinuation, irrespective of the relative risks of other SSRIs. Lambert J had little difficulty in rejecting this argument, noting the previous conclusions of Foskett J on the scope of the Claimant's case.
A trial of lead cases, listed for ten weeks, subsequently commenced on 29 April 2019. A list of issues was prepared for the trial, the first of which (Q1) was whether it was "appropriate in principle" to assess whether Seroxat was defective by seeking to establish whether it was "worst in class". If it was not, the claims would fail and it would not be necessary for the Court to consider any of the other issues in the case.
However during the course of the Claimants' opening submissions, an issue arose concerning the scope of the Claimants' pleaded case, which required Lambert J to give an urgent ruling. The Claimants advanced that, in determining whether the safety of Seroxat is such as persons generally are entitled to expect under section 3 of the CPA, the Court should infer or assume that Seroxat has no relative benefits when compared with other drugs in the appropriate comparator class, i.e. the Court should assume "a level playing field" of risks and benefits as between the drugs in the comparator class, save for the single characteristic which was said to constitute the "defect".
GSK reminded the Court that the case had been carefully case managed to trial and that there had been a series of Court rulings in which the Claimants' case had been defined as being that Seroxat was defective because it was "worst in class" for discontinuation symptoms. GSK had maintained from the outset that the Claimants' pleaded case on defect, i.e. a comparative case based on a single adverse event, was the wrong approach and that a holistic approach should be taken in determining the safety of a prescription medicine. Accordingly GSK's view was that Q1 should be answered in the negative and that should be determinative of the claims.
Lambert J gave a ruling on 9 May 2019 as to the scope of the Claimants' case on defect: [2019] EWHC 1167 (QB). In her decision, Lambert J held that the Claimants' case was limited to the "worst in class" case. The Claimants appealed against the ruling, and the ten week trial was adjourned pending determination of the appeal. The Court of Appeal (The Senior President of Tribunals, Hamblen LJ and Jackson LJ) unanimously dismissed the Claimants' appeal, confirming in a judgment of 8 November 2019 that the nature of the Claimants’ case on defect had been clearly and conclusively defined in previous court rulings, both by Foskett J and by Lambert J. The Court of Appeal noted that it had been "plainly impermissible" for the Claimants to seek to open their case in the way they had done at trial, and that they were in "complete agreement" with the analysis of the pleadings as set out in the prior rulings.
The Claimants sought permission to appeal the Court of Appeal's decision, but were refused both by the Court of Appeal itself and subsequently the Supreme Court.
Consequently, GSK applied to the Court for a restored trial of the lead claims at which the Court would:
- Use its case management power under CPR 3.1(2)(j) to hear and determine Q1 before the other questions for trial;
- Determine Q1 in GSK’s favour;
- Enter judgment on all of the claims currently managed as part of the Seroxat Group Litigation in favour of GSK; and
- Make provision for the inter partes costs (i) thrown away by the adjournment of the trial and (ii) of the action at first instance.