Bailey & Ors v Glaxosmithkline (UK) Ltd [2016] EWHC 178 (QB)

Case No TLQ/15/1275

[2016] EWHC 178 (QB)

IN THE HIGH COURT OF JUSTICE

QUEEN'S BENCH DIVISION

Venue Royal Courts of Justice, Strand, London, WC2A 2LL

Date 04/02/2016

Before

MR JUSTICE FOSKETT

Between

SANDRA BAILEY AND OTHERSClaimants

GLAXOSMITHKLINE (UK) LIMITEDDefendant

Jacqueline A. Perry QC, Niazi Fetto and Timothy Killen (instructed by Fortitude Law) for Claimants

Malcolm Sheehan QC and Andrew Kinnier (instructed by Addleshaw Goddard LLP) for Defendant

Hearing Hearing dates: 28 October 2015 and 14 December 2015

Judgment

Introduction

[1]A case management hearing in this matter was listed before me on 28 October 2015. It was adjourned part heard until 14 December 2015 for the reasons set out in the brief ex tempore ruling I gave on that day, the terms of which are set out in Appendix 1 to this judgment. The order made consequent upon that ruling is set out in Appendix 2. On 28 October Ms Jacqueline Perry QC represented the Claimants. Because Ms Perry was unavailable on 14 December Mr Niazi Fetto made oral submissions in support of the Skeleton Argument signed by her, Mr Fetto and Mr Killen and in response to the submissions made on behalf of the Defendant by Mr Malcolm Sheehan QC.

[2]In very short summary, the Defendant seeks an order or orders that would have the effect of bringing these proceedings to a permanent halt, the proceedings having effectively been stayed since January 2011. The Claimants wish to proceed to trial and seek appropriate orders and directions to that end. The trial had originally been fixed to commence on 1 February 2011 before Mackay J with a time estimate of 3½ months, but the proceedings stalled shortly before trial in the circumstances to which I will refer below.

[3]This judgment represents the conclusions I have reached concerning the issues raised.

Background

[4]The proceedings relate to an anti-depressant drug with the generic name of Paroxetine. It is better known by its trade name Seroxat in the UK. Its trade name in the USA and elsewhere is Paxil. It is available only on prescription in the UK.

[5]The drug is a member of the Selective Serotonin Re-uptake Inhibitor (‘SSRI’) family. It is used (and indeed licensed in the UK) to treat depression, obsessive compulsive disorder, panic disorder (with and without agoraphobia), social anxiety disorders/social phobia, generalised anxiety disorder and post-traumatic stress disorder. It possesses a number of side effects in common with other anti-depressants of a similar type. However, what is sought to be alleged in these proceedings is that it is worse than other drugs of a similar nature in relation to symptoms following discontinuation of its use. It is pleaded on behalf of the Claimants that “the capacity of [Seroxat] to cause adverse effects consequent upon or following discontinuance (withdrawal) [is] such as to prevent or make more difficult the ability of users to discontinue, withdraw from or remain free from taking [it], to an extent greater than with other SSRIs.”

[6]That is the essential (and primary) nature of the case advanced. If that allegation is established as a matter of fact, it is alleged that it gives rise to the conclusion that the drug is “defective” within section 3 of the Consumer Protection Act 1987 (‘the 1987 Act’).

[7]The alternative (and secondary) allegation is that Seroxat is defective because it is “marketed and sold without warnings that it [causes] more or greater symptoms on discontinuation than all other SSRIs”.

[8]All these allegations are hotly contested by the Defendant, the manufacturer of the drug. Drawing from the initial Skeleton Argument of Mr Sheehan and Mr Andrew Kinnier for the Defendant in order to determine the response to the claim, the essential factual allegation to which I have referred is denied and it is said, in any event, that the issue of whether a prescription-only drug is “defective” cannot be determined simply by “comparing the incidence and/or severity of a particular adverse reaction against the incidence and/or severity of the same adverse reaction after treatment with another [drug]”. That being the primary response of the Defendant, it follows that the need for the kind of warning said by the Claimants to be necessary is denied. Furthermore, it is contended that if, contrary to the Defendant’s primary case, it is established that Seroxat has more profound withdrawal consequences than other anti-depressants (and/or there was a need for a warning to that effect), it would not result in the drug being “defective” within the 1987 Act. Finally, it is said that if the primary case fails, the Defendant “is entitled to rely on the development risk defence”, a reference presumably to section 4(1)(e) of the Act.

[9]The essential question is the extent to which it is or is not appropriate to permit these issues to be ventilated, but before addressing that question a general contextual review of the litigation concerning Paroxetine is not out of place.

Litigation concerning Paroxetine

[10]Various references were made in, in particular, the Claimants’ Skeleton Arguments to other litigation in which the Defendant had been involved or is involved. It was not entirely clear to me to what extent this informed the issues that I was called upon to consider, but at the conclusion of the hearing on 14 December 2015 I asked the parties to supply me with a summary of other litigation throughout the world concerning Paroxetine.

[11]I will not set out in detail the material to which each party has drawn attention in this connection, but I will endeavour to summarise. Although the list of actions provided to me on behalf of the Claimants is longer than that provided by the Defendant, a cursory comparison suggests that they largely cover the same material. Overall, it would seem that in the USA between 2000 and 2005 over 3500 claimants alleged that they suffered discontinuation symptoms when they attempted to reduce or discontinue the use of Paroxetine and in 2005 a confidential settlement agreement with a total of 3,294 eligible claimants (whose claims would otherwise have gone to a jury trial) was reached with no admission of liability. From 2003 a cohort of claimants filed a “putative class action” consisting of all California residents who paid for prescriptions of Paroxetine in California in which it was alleged that they sustained economic damage and were entitled to reimbursement or other relief due to alleged “discontinuation symptoms.” In January 2012 a class-wide settlement with no admission of liability was achieved.Again, the claims would have gone to a jury trial in the absence of settlement.

[12]These seem to be the two actions (or series of actions) where the “discontinuation symptoms” issue was raised directly. There have been other lawsuits in the USA in which allegations have been made that the drug has caused other significant, unwanted effects, both in adults and in children for whom it was prescribed as part of paediatric care. Further lawsuits were brought alleging its deleterious impact upon pregnancies which resulted in, so it was alleged, children being born with congenital defects. In 2012 there was also a plea of guilty by the Defendant to an allegation concerning its marketing in the context of a wide-ranging set of allegations against the Defendant by the US Department of Justice. As I understand it, it was alleged that Paroxetine had been “misbranded” as a drug appropriate for use in patients under the age of 18 when it was said that the research underlying the safety of such use did not support that conclusion. The Defendant’s position is that it pleaded guilty to that allegation because it was a strict liability offence.

[13]Whatever gloss may be put by either party upon any feature of the litigation to which I have referred, there is no case to which my attention has been drawn where a definitive finding concerning the “discontinuation symptoms” associated with withdrawal from Paroxetine use has been made. It would, however, be idle to pretend that the drug is not a controversial drug given the litigation to which it has given rise over the years. That, of course, is by no means determinative of the issues I have to decide. The Defendant will, of course, say that the numbers of those who have claimed that adverse effects have arisen, although they appear to be large, are very small in comparison to the number of patients who have been treated successfully with Paroxetine.

This litigation

[14]Interest in litigation in the UK concerning Seroxat seems to have begun in about 2002 following a BBC Panorama Programme entitled ‘Secrets of Seroxat’. A large number of people came forward in consequence claiming to have suffered serious consequences from taking it. Many claimed that they had suffered serious adverse effects upon trying to discontinue taking it (including, in some cases, the generation of suicidal thoughts) and some claimed that in spite of many attempts to withdraw from its use they had been unsuccessful.

[15]A large group of claimants came together for the purposes of making claims and instructed the firm Hugh James. Initial supportive advice was given by Mr Stephen Irwin QC, as he then was. The first letter of claim was sent in March 2004 and for a time from 1 March 2004 all claimants had the benefit of public funding in relation to the generic element. However, as I understand it, that position was reviewed subsequently and the public funding not fully reinstated until December 2007. Nonetheless, a Group Litigation Order (‘GLO’) was made on 9 July 2007 and Particulars of Claim, settled by Mr Simeon Maskrey QC and Mr Julian Matthews, were issued in December 2007 (by which time Mr Irwin had been appointed to the High Court Bench) in relation to 5 Lead cases chosen by the Claimants. The pleading contained the general assertions referred to in paragraphs 5 and 6 above. I am told that Mr Maskrey and Mr Matthews (both, of course, very experienced practitioners in this field) at that stage assessed the litigation as having good prospects of success and were, at that stage at any rate, instructed on Conditional Fee Agreements (‘CFA’). As I understand it, the CFAs related to the individual cases, but the Public Funding Certificate to which I will refer in paragraph 16 below related to the generic issues that really lie at the heart of these proceedings.

[16]The funding position as from 17 December 2007 was that, despite the opposition to the grant of public funding by Messrs Addleshaw Goddard on behalf of the Defendant, a full funding Public Funding Certificate was granted for the Claimants represented by Hugh James (numbering 468). (There were also 24 other claimants represented by other solicitors and one litigant in person.) That certificate, as previously indicated, related to the generic issues. Those issues are central to the pleaded issues to which I have already referred, issues which it is essential for any claimant to establish in his or her favour before any individual case has any prospect of success.

[17]As foreshadowed in paragraph 16, the proceedings were brought on behalf of 493 individual claimants, but, as is normal in a situation where there is a GLO, a number of lead Claimants were chosen. Furthermore, Hugh James was appointed as Lead Solicitor with a very experienced practitioner, Mr Mark Harvey, as the partner primarily responsible for the litigation.

[18]Simply spelling out the essential issues in the case (see paragraph 19 below) leads to the obvious conclusion that its outcome will depend to a large degree on expert evidence and on the evaluation of what is revealed, either by way of disclosure or otherwise, about the development of Paroxetine. Those aspects of the preparations for the trial of the generic issues were case-managed by, in the first instance, the then Senior Master, Master Turner, and then by his successor, Master Whitaker. Master Turner made the GLO to which I have referred, but the order of 29 October 2008 (made by Master Whitaker) represents a convenient starting-point for present purposes. All that I need to record at this stage of the chronology of events is that Professor Malcolm Lader OBE, Emeritus Professor of Clinical Psychopharmacology at the Institute of Psychiatry, had provided a supportive preliminary report for the Claimants which I believe was dated 30 September 2005 and supplemented later that year.

[19]The order identified a list of “common or related issues of fact or law” for determination “in the Seroxat Group Litigation in the context of the facts and matters of the individual claims” as follows:

“(a) Does Seroxat have a “capacity to cause adverse effects consequent upon or following discontinuance (withdrawal) such as to prevent or make more difficult the ability of users to discontinue, withdraw from or remain free from taking”

Seroxat to a greater extent than all other Selective Serotonin Re-uptake Inhibitors (“SSRIs”)? (b) Should the alleged defect in Seroxat, a prescription-only medicine, be established by comparing the incidence and/or severity of adverse reactions associated with that medicine against the incidence and/or severity of adverse reactions associated with another prescription-only medicine? (c) If the alleged defect in Seroxat, a prescription-only medicine, can be assessed by comparing such a medicine against other prescription-only medicines, should the proper range of medicines against which Seroxat be compared be limited solely to other members of the SSRI class? (d) If such a greater capacity exists, should a warning of such a greater capacity have been included in the Defendant’s product literature? (e) If such a greater capacity does exist and/or if there was a failure to warn of such a greater capacity, can, as a matter of law, Seroxat be rendered defective within the meaning of section 3 of the Consumer Protection Act 1987 (“the 1987 Act”)? (f) If such a greater capacity does exist and/or if there was a failure to warn of such a greater capacity and if, as a matter of law, Seroxat can therefore be rendered defective within the meaning of the 1987 Act, is or was Seroxat a defective product within the meaning of section 3 of the 1987 Act? (g) If Seroxat is or was defective, is the Defendant able to rely upon section 4(1)(e) of the 1987 Act, that the state of scientific and technical knowledge was not such that a manufacturer might have been expected to discover the defect? (h) Do the “adverse effects” alleged by the Claimants or any of them amount to an actionable personal injury? (i) Has Seroxat caused the injuries alleged in the individual cases in the Seroxat Group Litigation? (j) What range of general damages award should be made in the individual cases in the Seroxat Group Litigation? (k) Are the Claimants’ claims, or any of them, extinguished pursuant to section 11A(3) of the Limitation Act 1980 and/or statute-barred pursuant to section 11A(4A) of the Limitation Act 1980?"

[20]In addition to providing a timetable for pleadings, disclosure and expert evidence in relation to the 10 Lead Cases, the order also provided a timetable for disclosure in respect of the generic issues and permission for each party to rely upon the evidence of “a single expert” in psychopharmacology, pharmacokinetics and epidemiology. There was a “costs control” provision requiring the parties to exchange costs estimates up to and including expert evidence within 14 days of the order and requiring on a monthly basis an update on the estimates to enable monitoring of each party’s adherence to the estimates. The case, of course, commenced before the current costs budgeting provisions were in force.

[21]By an order of Master Whitaker dated 19 May 2009 the list of experts was extended to enable the Defendant to rely on an expert in the discipline of medical statistics (presumably so as to be able to deal with issues raised by Professor Hotopf: see below) and also to rely upon an expert “in the discipline of the regulation of medicines”.

[22]So far as the Claimants’ experts were concerned at that stage, they were Professor Lader (psychopharmacology), Professor Matthew Hotopf (epidemiology and statistics) and Professor John Hughes (pharmacokinetics).

[23]The Defendant’s experts were Professor Allan Young (psychopharmacology), Professor John Newton (epidemiology) and Professor David Greenblatt (pharmacokinetics). In addition they were to call Professor Robert Gibbons (a bio-statistician and thus their expert in statistics) and Dr Rashmikant Shah (as the regulatory expert). There was controversy about the extent to which Dr Shah’s evidence was relevant and/or admissible and it appears that Mackay J made an order on 28 September 2010 in which he directed that a redacted version of Dr Shah’s report would be admissible at the trial.

[24]It was suggested by Mr Hanison (see paragraph 70 below) in his first witness statement (and not controverted on behalf of the Defendant) that at least some of these experts had prepared reports in proceedings in the USA and that, accordingly, the Defendant had, in effect, a ready-made team of experts.

[25]At all events, the experts on each side provided reports and supplemental reports and those of a like discipline discussed their reports with a view to providing joint statements. There were various changes in the timetable, but it would seem that all the joint statements were agreed by July/August 2010, the final such statement (as between Professors Lader and Young) being dated 23 August 2010. Before saying anything further, I should record (in summary form) the extent of the material available by the time of the production of the joint statements.

[26]Subject only to the very limited area referred to in paragraph 56 below, I have not reviewed the detail of this material for the purposes of making the necessary decisions in these applications. However, it is appropriate to note the volume of the material generated in the process I have described.

[27]Professor Lader's first (disclosed) report ran to 130 pages and he indicated the substantial volume of material (in the form of publications relevant to the "withdrawal issue" and documentation from the Defendant concerning the licensing processes and the clinical trial processes) that he had considered. The Defendant raised questions on that report to which he responded and he then supplied a supplementary report (responding to points made by Professor Young in his report) which ran to 25 pages.

[28]Professor Hotopf (who is, or at least was at the material time, Professor of General Hospital Psychiatry and Consultant Liaison Psychiatrist also based at the Institute of Psychiatry) prepared a report, the substance of which ran to 195 pages. It would appear that he had the same material available to him as had Professor Lader. He too was asked questions by the Defendant to which he responded and also supplied additional material. He too supplied a supplementary report designed to respond primarily to the reports of Professors Newton and Gibbons. That report ran to some 40 pages.

[29]Professor Hughes (whose main area of expertise is in the field of Neuropharmacology) prepared an initial report running to 18 pages, a response to some questions put to him by the Defendant, a clarification report and then a supplementary report.

[30]On the Defendant's side, Professor Young (who is Professor of Psychiatry in the Department of Psychiatry at the University of Columbia in Canada) prepared a report running to 106 pages. He also prepared a supplemental report running to 125 pages in which he commented on matters raised in the reports of Professors Lader and Hotopf.

[31]Professor Gibbons (who was Director of the Centre for Health Statistics and Professor in the Department of Bio-Statistics, Mathematics, Statistics and Computer Science and Psychiatry at the University of Illinois, Chicagoand is now Chair of Mood Disorders at King's College London where he is also Director of the Centre of Affective Disorders with the Department of Psychological Medicine in the Institute of Psychiatry) prepared a report running to 109 pages. His supplemental report, dealing with issues raised in the reports of Professors Lader and Hotopf, ran to 55 pages.

[32]Professor Newton (who is a Public Health Physician and Honorary Professor of Public Health and Epidemiology at Manchester University) prepared a report running to 85 pages and a supplemental report, commenting on the reports of Professors Lader and Hotopf, running to 77 pages.

[33]Professor Greenblatt (who is Professor and Chairman of the Department of Pharmacology and Experimental Therapeutics at Tufts University School of Medicine, Massachusetts) prepared an initial report running to 31 pages and a supplemental report, commenting on the reports of Professors Lader, Hotopf and Hughes running to some 30 pages.

[34]Dr Shah produced an initial report (including Appendices) running to 415 pages. He had been Senior Medical Officer with what was once known as the Medicines Control Agency (part of the Department of Health) between 1987 and 2004 and at the time of preparing his report was providing consultancy services to pharmaceutical companies throughout the world. As indicated above (see paragraph 23), there was controversy about his evidence. He prepared a supplemental report in response to regulatory issues said to have been raised in the reports of the Claimants' experts. That supplemental report ran to 27 pages.

[35]It is clear, therefore, that a substantial amount of expert opinion was advanced by the time the experts of like discipline discussed their reports on the usual basis. As I have indicated (see paragraph 25), Professors Lader and Young produced their joint statement in late August 2010 having discussed matters face to face on 21 June and thereafter by telephone on 16 August.

[36]The joint report of Professors Hotopf and Gibbons followed a face to face meeting on 9 June 2010. The joint statement ran to some 30 pages. I will refer to one particular feature of that joint statement to which Mr Sheehan draws attention below (see paragraph 56).

[37]The joint statement of Professors Hotopf and Newton followed a meeting on 30 June 2010 and ran to some 20 pages.

[38]Professors Hughes and Greenblatt met on 1 July 2010 and prepared a 6-page statement at the end of July, but Professor Hughes supplemented that statement to aid understanding of certain areas of disagreement.

[39]Dr Shah did not discuss his report with any counterpart on the Claimants’ side because there was none.

[40]Given that the trial was then some 6 months hence, and the material evidence was complete, it was obviously a time when a review of the prospects of success should take place. Indeed the Legal Services Commission (‘LSC’) sought an Opinion from Leading Counsel for the Claimants on the evidence and merits of the Claimants’ case before it would move into what was described as the "final contract stage, namely trial preparation and trial itself".

[41]On 4 October 2010 the Opinion was delivered to the LSC and on 25 October it issued (through Hugh James) a "Show Cause" notice to each of the individual Claimants to demonstrate why the LSC should continue its funding of the "generic" case under the Public Funding Certificate. Whilst the precise nature of Mr Maskrey’s Opinion is unknown (the Opinion itself being privileged) it is not speculative to conclude that he was more pessimistic then about the prospects of success of the case than he had been at an earlier stage. Some indications of the reasoning appear below (see paragraphs 53 - 59), but the position was that the individual Claimants were given until 8 November to make representations about the Public Funding Certificate.If, notwithstanding any such representation(s), the Public Funding Certificate was discharged then there would be a right of appeal to a Special Cases Review Panel (or, as I thought it was called, a Special Controls Review Panel).

[42]On 28 October 2010 Mackay J was told of the position and he gave certain directions designed to ensure that the Defendant’s solicitors were kept informed of developments with regard to the progress of the representations made to the LSC.

[43]On 29 November 2010 the LSC concluded that the Public Funding Certificate should be discharged save that it should remain in place for the limited purpose of: i) providing those Claimants who wished to discontinue their action with an opportunity to receive advice on the options available to do so; and ii) providing those Claimants who wished to challenge the decision of the LSC to discharge the Public Funding Certificate with an opportunity to do so through the Special Cases Review Panel procedure.

[44]On 30 November 2010, 369 Claimants discontinued their claims, including 8 of the chosen "Lead Cases". Shortly thereafter the Defendant accepted an offer made on behalf of the 369 discontinuing Claimants to pay its costs relating to the individual claims in the total sum of £165,127.50 (representing £447.50 each).

[45]A total of 124 Claimants decided at that stage not to discontinue, including 2 of the "Lead Cases". A Case Management Conference took place before Mackay J on 16 December 2010 when Mr Maskrey told him that the 124 continuing Claimants had appealed against the discharge of the certificate by which I understand him to have meant that they had invoked the Special Cases Review Panel procedure. Apparently, of this group 15 had indicated that they would continue with their claims even if the Special Cases Review Panel upheld the discharge the Public Funding Certificate, but the others would discontinue if the appeal against the discharge of the certificate failed. (There were, in addition, 4 other potential “continuing Claimants”, two of whom were acting in person and two of whom had issues concerning their capacity to litigate.) Mr Maskrey told the Judge that the “appeal panel” had met on 15 December (in other words, the day before the hearing) and that the Public Funding Certificate would remain in place only to the extent of enabling the assisted persons to seek clarification of aspects of his Opinion. Thus a further Opinion from Mr Maskrey was sought and it would take a little while for that Opinion to be formulated, particularly since at that stage Mr Maskrey did not know precisely what he was to be asked. It followed that, at that stage, there was a theoretical possibility that the 124 Claimants could proceed with funding, but that if the funding was withdrawn there might be 15 (or 19) who would seek to proceed even without funding.

[46]Mackay J vacated the trial listed for 1 February 2011 and directed that a further Case Management Conference should take place no later than 21 January 2011. Indeed a Case Management Conference was fixed for 21 January 2011.

[47]It would seem that Mr Maskrey’s further Opinion was sent to the LSC’s panel on or about 18 January 2011 and since it was unlikely that any substantive progress would have been made by 21 January an order was made by agreement whereby the CMC was adjourned with a view to being re-listed for half a day on the first available date 3 weeks after receipt by the Defendant of Hugh James' notification of the final decision by the Special Cases Review Panel or upon earlier application by the parties. It was at that stage that the case was effectively stayed as between the potential continuing Claimants and the Defendant because there ensued a prolonged process by which those Claimants sought to persuade the LSC to change its position. I should, perhaps, observe (though I am not sure it is really more than a matter of the phraseology chosen) that the claims were not in fact “stayed”, but the CMC was simply adjourned, to be restored when the outcome of the review process was known.

[48]As it was, it was not until 30 January 2015, some 4 years later, that Hugh James wrote to the Court (and Addleshaw Goddard) confirming that the Legal Aid Agency (formerly the LSC) had informed them that the Special Cases Review Panel had concluded its review and that the Public Funding Certificate had been discharged as of 29 January 2015.

[49]Apart from Hugh James maintaining its responsibilities of notifying the Defendant of the state of the register of the Claimants under the GLO (which continued in place), nothing substantive occurred in the litigation for that 4-year period.

[50]As I have indicated, during this period efforts were being made to persuade the Special Cases Review Panel not to discharge the certificate. As I understand it, Ms Perry and Mr Fetto were engaged from some time in 2012 on a pro bono basis by Dr Sarah-Jane Richards, who herself had been approached by a number of Claimants to assist them in trying to preserve the Public Funding Certificate. Dr Richards had, I understand, been working for Hugh James whilst that firm was handling the litigation and she maintained her interest in the case as an independent consultant after the Public Funding Certificate was discharged. Ms Perry told me that she and Mr Fetto were instrumental in making substantial written and ultimately oral representations to the Panel.

[51]As will be apparent, those representations were unsuccessful.

[52]I have been told that some part (about 12 months) of the extended period during which these matters were considered was occasioned by the desire of the Legal Aid Agency to obtain a further Opinion from another Leading Counsel on the prospects of success. That was, I am told, formulated solely on the basis of the papers and without the benefit of a conference with any or all of the experts.

Why was the Public Funding Certificate discharged?

[53]In answer to an inquiry I made during the second hearing I have been told by the Claimants’ present solicitors that no publicly issued decision of the Panel was made, but that the position regarding funding was communicated by a letter dated 29 January 2015 to Secure Law Limited, solicitors apparently then instructed by the Claimants. It follows that there is no clear indication emanating from the Panel that demonstrates to me the basis for the decision.

[54]Ms Perry told me that Mr Maskrey’s Opinion of October 2011 was to the effect that he could not satisfy the Legal Aid Agency that the case could achieve “more than a 50% rate of success” which I take to mean that he regarded the prospects as 50/50. Mr Hanison said in his first witness statement that “it is not disputed that the outcome of the Special Cases Review Panel … assessment was that the Claimants’ case had ‘poor prospects of success’”. That expression is one that was used by Hugh James in a letter to Mackay J’s Clerk dated 3 June 2013. That rather suggests a less than 50/50 chance. However, it is likely that the potential costs involved in preparing for a 12-week trial and then proceeding with such a trial entered into the assessments being made at the time. It would have required a substantial commitment of public money to pursue a case with only a 50/50 or less chance of success as assessed by Leading Counsel.

[55]Because it has not been my role in these applications to consider the intrinsic merits of the Claimants’ case (because there is no application for a strike out or for summary judgment as such before me), I can merely note this assessment. It is a relevant factor in considering whether and if so how to exercise the case management jurisdiction of the court, but ultimately it would be for the court, if invited to do so on a strike out or summary judgment application, to make its own assessment: whether a case is permitted to proceed, once it is before the court and has not been discontinued, is a matter for the court, not the Legal Aid Agency or indeed for some alternative source of funding. I accept Mr Fetto’s submissions on that point.

[56]As I have said, I have not considered the overall merits of the case as it is presently configured by reference to the expert evidence as it presently stands. Mr Sheehan has drawn attention to one feature of the joint statement between Professor Gibbons and Professor Hotopf which, he submits, is important:

“Please consider whether Seroxat causes more severe adverse events on discontinuation of treatment than (a) the comparator medicines you consider appropriate and (b) if different, other SSRIs. If you feel they provide relevant comparative evidence, please consider and give your views on the evidence referred to at 3.1-3.5 above. RG With respect to severity, most studies conclude that the majority of symptoms were not severe and are no longer present after the first post-treatment week. The CSM (2004) review, clearly indicates that in general these symptoms are mild in nature and are self limiting. The literature is far less detailed regarding severity than it is with respect to incidence. While the absolute frequency of withdrawal symptoms may vary from study to study, I can find no evidence that the severity of those symptoms was significantly different between drugs. In fact, I know of no study that actually provided a head to head statistical comparison of the severity of symptoms between two or more SSRIs. MH I agree that the information on severity is sparse. I retract the opinion I made in my original report that paroxetine was associated with a five fold increase in clinically significant DS compared with other SSRI antidepressant, as I think this comment suggests a greater precision on this point than the data can support. I accept that with respect to the Himei study, all patients who developed WS in accordance with the Black criteria had paroxetine reintroduced. This was not in and of itself a measure of severity as suggested in my report. However it remains my opinion that the evidence supports paroxetine being associated with more severe symptoms upon discontinuation than other SSRIs.”

[57]Mr Sheehan says that “the rate of severity of discontinuation symptoms [is] absolutely fundamental to the Claimants' claim” and that, as he characterised it, this concession weakened the Claimants’ case significantly.

[58]Whilst it is not wholly clear whether Professor Hotopf was referring to this particular part of the joint statement, Mr Hanison has said that Professor Hotopf has explained to the new legal team that his changed position still supported the main thrust of the case that the adverse effects of the drug were “worst in class” although to a slightly lesser degree than he had previously suggested. He has apparently expressed the view that he felt that he had been 'ambushed' into agreeing with a proposition based upon the limited data that he was asked to consider which was correct as far as it went, but hardly touched upon the wider epidemiological picture which remained as before. It is, of course, possible to see why the apparent concession, if unexplained, might be seen as undermining the essential case sought to be advanced.

[59]I do not consider I should speculate on what may have been a combination of reasons for reaching the decision that the Special Cases Review Panel did, but the inference to be drawn is clear, namely, that the factual case (and perhaps the legal case based upon the 1987 Act) was not perceived at that stage to be strong enough to justify substantial public expenditure when the perceived potential return for individual Claimants was not high even if their cases were established. I will return to the potential quantification of the individual claims later.

What has happened since July 2015?

[60]Although Hugh James remained as the court-appointed lead solicitors for the purposes of this action, it would seem that Dr Richards was playing an instrumental role in trying to secure the continuation of public funding for the remaining Claimants (see paragraph 50 above). I need not dwell on it for present purposes, but there was an occasion in May 2013 when a firm of solicitors called Secure Law purported to serve a Notice of Change of Solicitors on Addleshaw Goddard. Hugh James challenged this and, in short, matters remained formally as they were until the events of July 2015 to which I will refer further below. However, it appears that Dr Richards was employed for a while by Secure Law although she gave up that position when she assumed a role in the firm known as Fortitude Law (see paragraphs 70 - 76 below).

[61]Once Hugh James had confirmed the outcome of the review conducted by the Legal Aid Agency, the questions arose of whether the remaining Claimants were to continue with the proceedings and, if so, whether they were to be represented and, if so, by which firm of solicitors. Matters were somewhat confused for a number of months. In the first instance, Hugh James were obliged to restore the adjourned CMC pursuant to the order of 21 January 2011 (see paragraph 47 above). However, in January 2015 it appeared to Hugh James that Secure Law was to take over the representation of the Claimants. However, the position from the perspective of the Defendant was unclear and in March 2015 Addleshaw Goddard issued an application to restore the CMC to enable the court to consider the position. In the first witness statement of Ms Louisa Caswell dated 26 March 2015 the court was invited to “give detailed consideration [to] the next steps in this litigation, in circumstances where it appears that at least some of the Claimants may intend to pursue their claims.” I have been told that Secure Law confirmed in April 2015 that it would “not be going on the record as acting for the remaining litigants” in these proceedings.

[62]The papers were put before me and in due course I made an order on 15 June 2015 by virtue of which I required the then 117 identified Claimants to confirm by 24 July 2015 whether they were proceeding with their claim in default of which their claim would be struck out.

[63]In the light of the material now available, it is clear that there was a good deal of activity “behind the scenes” which led to the recognition by the Solicitors Regulation Authority on 15 July 2015 of Fortitude Law as a firm of solicitors of which Mr Darren Hanison is the Managing and founding partner. He had written to Addleshaw Goddard on 11 June 2015 to explain that he would be able to take the litigation forward as soon as the SRA regulatory formalities had been completed “at which point Fortitude Law will come on the record as representing the Seroxat Litigation Claimants.” At about this time he was also in discussions with funders and insurers with a view to obtaining funding for the litigation.

[64]He describes Fortitude Law as a law firm which has a claimant based, civil litigation portfolio including product liability (medical devices and pharmaceuticals) and professional negligence including medical negligence. It is a recognised sole practitioner law practice. Mr Hanison has said that the firm was “not established solely to litigate” this case, but there can be little doubt that it was created as a vehicle by which this litigation could be continued. I will return to the constitution of that firm below (see paragraphs 70 - 73), but to complete the chronology at this stage of the story, shortly before the expiration of the deadline set by my order, on 22 July 2015 Fortitude Law served a Notice of Change of Legal Representative and 103 out of 117 remaining Claimants confirmed that they intended to proceed with their claims.

[65]Against that background, on 26 August 2015 the adjourned CMC was restored before me on 28 October 2015.

[66]Various communications took place between Addleshaw Goddard and Fortitude Law during August, September and October concerning the adequacy of the firm’s resources to maintain the litigation, the adequacy of the proposed funding arrangements, including any After The Event (‘ATE’) insurance cover, and the future arrangements concerning expert evidence.

[67]Suffice it to say for present purposes that the Defendant took the view that the information supplied on all issues was inadequate and intimated for the first time in Ms Caswell’s witness statement of 23 October 2015 that its primary position would be that the claims should not be permitted to proceed. The alternative position taken was that under the terms of an unless order, the Claimants’ representatives should provide a statement in which they would be required to set out, in detail, how they proposed to prosecute the litigation (particularly in relation to lead cases and the expert evidence), the adequacy of the resources they could commit and the adequacy of the proposed funding arrangements.

[68]As previously indicated, I adjourned that CMC part heard so that in the meantime the further information referred to in the order I made (see Appendix 2) could be supplied. It was not expressed as an “unless order”, but plainly I intended the information to be supplied.

The information now available and the proposals concerning expert evidence

[69]I propose to summarise the information now available concerning various areas of potential importance rather than dwell on the process by which it emerged. I will indicate, where relevant, what Mr Sheehan has said about that process, but the information as it is represents the material I need to assess.

(i) Fortitude Law

[70]Mr Hanison is a solicitor with over 20 years post qualification experience over, he says, a wide area of commercial/insurance disputes including disputes “in respect of all types of professional service suppliers as well defective products manufacturers (both medical and non-medical).” He proposes to dedicate 50% of his time to this litigation until its conclusion.

[71]Dr Richards is a solicitor with 11 years post qualification experience, but also has been involved in this litigation from the outset. She has, I am told, a science-based degree from Cambridge and Mr Hanison has said that her “detailed scientific background has been essential throughout to the identification and comprehension of the scientific issues inherent in this case.” She will, it is said, be involved exclusively in this litigation and will relinquish her current 1-day per week role as an Assistant Coroner.

[72]Mrs Amanda Turner, who is a senior paralegal, will also attend to this litigation on a full-time basis. She has previously been involved in the litigation, particularly in clinical trial and academic publication reviews. She has, Mr Hanison says, 7 years’ experience of claimant litigation. He also says that she has previously managed a caseload of defective product claims brought under the Consumer Protection Act 1987.

[73]Finally, there is Miss Kate Green, who was a final year psychology student in 2009, and, according to Mr Hanison, “assisted previous solicitors with academic publication identification and review … and extraction of relevant data from disclosed clinical trials”. She has subsequently completed a further degree in forensic psychology and is available to assist the litigation again through the identification and extraction of relevant data from disclosure. She is not a qualified solicitor, but acts as a consultant to Fortitude Law in relation to this litigation. The time she spends on the case depends on what is required.

[74]Mr Hanison has, of course, also drawn attention to the team of Counsel and says that “additional staff may be appointed as the litigation develops”.

[75]It is contended on behalf of the Defendant that this is not a sufficient team to cope with the difficulties of this litigation.

[76]I will return to the question of the adequacy of this team in due course (see paragraph 135 below). (ii) funding

[77]In his first witness statement Mr Hanison said this about the future funding of the litigation from the Claimants’ point of view:

“I am able to confirm the litigation is funded to trial with the benefit of commercial litigation funding provided by Managed Legal Solutions Ltd (who despite their absence from the list on the AFL website, I am informed abide by the Code of Code Conduct of Litigation Funders) and ATE insurance provided by Belmonte Ltd. on behalf of Gable Insurance AG. Lamp Insurance ATE insurance policies are in place in respect of any individual claimant’s case adverse costs and these policies remain the same.”

[78]This, of course, gave little hard information about the extent of the funding. The order made following the hearing on 28 October was that a further statement was required that addressed “fully and precisely” in relation to “the Claimants’ funding arrangements and ATE insurance arrangements in respect of adverse costs orders, a detailed explanation of the reasons and underlying assumptions relied upon for contending that those arrangements provide “adequate” cover having regard to the parties’ costs incurred thus far and their likely future costs if the litigation proceeds to a trial of 3½ months.”

[79]In his further witness statement Mr Hanison said this:

“19. The Defendant has already been advised … that funding has been provided by Managed Legal Solutions Limited (MLS). The Claimants are not obliged to disclose their level of funding but suffice to say it significantly exceeds the remaining £500,000.00 previously available to the litigation under the terms of the Public Funding Certificate. The potential to increase funds has been agreed with MLS in the event the Claimants require further funds before and at trial. 20. Without waiving privilege in the content of these discussions or meetings, it is the case that … the funding arrangement was agreed after extensive and rigorous evaluation and after several months of discussions, case analysis, and meetings between funders, insurers (and their external lawyers) and experienced counsel. 21. It is perplexing that the Defendant continues to raise as an issue the question of whether or not the Claimants have adequate funds to pursue the litigation against GlaxoSmithKline (UK) Limited. Previous funding availed to this litigation by the Legal Services Commission to trial did not exceed £1.5m. The funding currently secured by Fortitude Law significantly exceeds the residue of this sum. Furthermore, in spite of delays incurred by the Legal Services Commission, this remains a litigation which is well advanced. Funding provided under the Public Funding Certificate was a fixed sum with the Commission who made it clear that further funding would not be forthcoming in the event the funding pot was exhausted.”

[80]He went on to say that the ATE insurance put in place “will in the event of an unsuccessful outcome reimburse the Defendant’s reasonable costs up to £750,000” and pointed out that under the terms of the Public Funding Certificate the Defendant would not have received any adverse costs from the Legal Aid Agency in the event the litigation was either discontinued or failed. He suggested, therefore, that the Defendant was “in a far stronger position to receive adverse costs under the current ATE insurance indemnity arrangement and with the facility to increase the limit of indemnity already being in-built into the ATE insurance policy.”

[81]I will deal with the time estimate for the trial later (see paragraphs 116 - 118), but Mr Sheehan’s attack on this statement is framed on the basis that the Claimants “have not even started the process of compliance with the order” that was made. He contends that these paragraphs represent no more than a series of assertions which I am not in a position to evaluate because the basic information necessary to do so has not been provided. He says that merely to assert that the available funding significantly exceeds the £500,000 previously available under the public funding certificate without being told the figure means that it remains impossible to evaluate the adequacy of the figure. Furthermore, he submits that no information has been given about the underlying assumptions made that the funding is adequate.

[82]Mr Fetto’s response was, in effect, that whilst the information given in Mr Hanison’s second witness statement might not have been precisely what was ordered, there is sufficient there for the material factor to be determined. The material factor for this purpose is, he contends, whether the Claimants have sufficient funding to finish the litigation. He submits that the issue is not whether there is sufficient ATE insurance to meet the Defendant’s costs if the Claimants should lose(a) because that is almost akin to requiring the Claimants to give security for costs and

(b) it would be very difficult commercially to obtain such cover in any event (which would be to cover between £7.5 million and £15 million according to the estimates given by Ms Caswell). He may be right about (b) but there is, as Mr Sheehan rightly says, no evidence about that, merely assertion. That said, however, I have to say that I would need some persuasion that it would be necessary for ATE insurance to be in place to cover such a level of recovery. Presumably, all the existing Claimants remain protected from any personal adverse costs consequences so far as the generic issues are concerned by the Public Funding Certificate that was in existence until it was discharged finally. That protection does not, of course, apply for the future: any such protection is afforded by the ATE insurance. If any of those Claimants discontinued now, there might, one supposes, be some relatively small liability for the Defendant’s costs concerning their own individual cases (cf. paragraph 44 above). However, they propose to continue with the generic issues with, as I have said, the protection of ATE insurance behind them. This does mean, as Mr Fetto correctly says, that there is the prospect of the Defendant recovering some part of its future costs in the event that the Claimants’ case fails even if the figure of £750,000 is not altered in the meantime. If Ms Caswell’s prediction as to the additional costs for the future (which, of course, may not reflect the recoverable costs) are correct, the £750,000 would not be adequate, but it does represent a beginning. I will return to the implications of this later.

[83]However, proposition (a) referred to in the preceding paragraph is correct and is, in some respects the obverse side of the coin considered by Thirlwall J in XYZ v Various

[2013] EWHC 3643 (QB)

. There the issue raised at a case management hearing was the extent to which a particular defendant was insured such that any award in damages in favour of the claimants would be met. Thirlwall J held, following the approach of Steel J in West LondonPipeline and Storage v Total (UK) Limited and TAV and Others

[2008] EWHC 1296 (Comm)

, that the insurance position of the particular defendant was not “a matter of dispute in [the] proceedings” and, accordingly, further information or disclosure about it was not permitted under Part 18. She emphasised that whether or not the claimants could enforce any judgment was not a matter that affected case management, but whether the particular defendant could fund the litigation to trial (and any appeal) did affect case management. Accordingly, she ordered the particular defendant to provide a statement or statements setting out whether it had “insurance adequate to fund this litigation to the completion of the trial and the conclusion of any appeal.” (I imagine the expression “insurance” was intended to embrace the question of whether an insurer was funding the litigation and I note that further submissions were invited on the precise phraseology of the order.)

[84]If that is the true issue in this case (and I am inclined to think that it is), then the question is whether I should be satisfied by what I had been told by Mr Hanison and also whether it is realistic in the context of the proposed changes in the Claimants’ expert team and the estimated length of the trial. Mr Sheehan makes the point that no supporting documentary evidence has been put forward by Mr Hanison to justify his statement. That may be so, but it is a statement made by an officer of the court to which a statement of truth has been appended. He suggests that there was £500,000 still available at the time the earlier proceedings stalled and that would have been sufficient to get through to the end of the trial as then envisaged. There is, he says, “significantly more” available now and also that there is agreement with MLS that the figure may be increased before and at trial if needed. Mr Fetto emphasised that there is funding to cover disbursements and a willing Counsel team acting on low fee CFAs.

[85]It has to be said that Mr Hanison’s approach is very broad brush and I am not sure that the information provided is as detailed as envisaged by the order I made. However, as Mr Fetto correctly said, this is not an exercise in judicial discipline – the question is whether the information is sufficient to reach the necessary conclusion about future funding. Even if it is not, one option at this stage is simply to take the information at face value and keep the progress of the litigation under review. I will return to the viability of that option in due course. (iii) experts

[86]Certain changes in the Claimants’ team of experts are proposed. One change to the Defendant’s team will be enforced if the case is permitted to proceed because of Dr Shah’s supervening ill-health. I will set out in the first instance what is proposed on the Claimants’ side. It is fair to say that there was some uncertainty about the position on 28 October. However, matters have clarified subsequently.

[87]The first proposed change is to substitute Professor David Healy, Professor of Psychiatry, Cardiff University, for Professor Lader as the Claimants’ neuro- psychopharmacology expert.

[88]The next proposed change is to relieve Professor Hotopf of his responsibility for statistics and to substitute Professor Glyn Lewis for him in that particular respect. Professor Glyn Lewis is Professor of Clinical Trials and Applied Epidemiology in the Division of Psychiatry at University College London. His expertise is in the methodology of clinical trials and the statistical analysis of randomised clinical trials. Professor Hotopf would remain as the expert in epidemiology.

[89]Professor Hughes would remain as the expert in pharmacokinetics.

[90]The consequence of this, if permitted, would be that the Claimants’ side would have four experts who would match the expertise of the four experts who remain in place on the Defendant’s side. The only area where the expertise would not be matched directly would be in the field of regulation, the area of Dr Shah’s experience. However, if the proceedings continue, it would be open to the Defendant to apply to substitute another expert (a search for whom has apparently already been launched, albeit unsuccessfully so far) and the court would be able to assess the extent to which evidence from such an expert was admissible and/or relevant. (I should say that it is acknowledged by Mr Sheehan that Dr Shah’s unfortunate unavailability has not been caused by the applications made by the Claimants, but he points to it as a potential prejudice suffered by the Defendant if the proceedings are allowed to continue.)

[91]There is no doubt that if these substitutions are made and either new reports are prepared or the newly appointed experts effectively adopt (either in whole or in part) the reports of those from whom they have taken over, the status of the previously prepared reports and the joint statements will be called into question. I will return to this, but Mr Sheehan has also sought to question the basis upon which Professor Lader seeks to stand down and the basis upon which Professor Hotopf wishes (as it would appear) to be relieved of one aspect of his current expert portfolio.

[92]So far as Professor Lader is concerned, he is approaching his 80th birthday in February 2016. It has been said on his behalf that he does not feel able to continue because of his advancing years and because of lack of relevant recent experience. Mr Sheehan made strong submissions that no evidence about his capacity to continue (including medical evidence) has been put before me and he has drawn attention to a recent extract from Google Scholar where, he says, it is shown that Professor Lader is still active.

[93]I do not find these submissions attractive. If someone with a distinguished background such as that possessed by Professor Lader reaches the age of 80 and says that he or she does not feel up to preparing for and taking part in prolonged court proceedings, then that position ought to be respected without the need for a medical report about the individual concerned. My brief perusal of the material referred to on the Google Scholar search suggests that much of the material was either review material or reference in other material to Professor Lader’s previously expressed views. But any work that he carried out will have been work carried out in the relative comfort of a private room and not in the glare and bustle of courtroom activity. The final unattractive aspect of the Defendant’s position concerning Professor Lader is that if he did continue to take part in the litigation (as, in effect, the Defendant wants him to do if the proceedings are to continue), it is not difficult to envisage the argument being advanced by the Defendant, when inviting the trial judge to consider the weight to be attached to his evidence, that he is now too old and out of date to have any relevant expertise to help the court.

[94]I regard the need to consider the substitution of Professor Lader by Professor Healy as something to be considered in the round and in the context of where this litigation currently stands, but I do not think that the points advanced against his substitution in principle have any intrinsic substance in them.

[95]Added to that consideration, it is clear that Professor Healy has relevant experience and has detailed knowledge of the issues involved in this litigation. I say nothing, of course, about whether his evidence would or would not be acceptable to the court in due course, but the Claimants are seeking to provide a substitute for Professor Lader with appropriate experience.

[96]Mr Sheehan also seeks to criticise and question the proposed substitution by Professor Glyn Lewis for part of Professor Hotopf’s portfolio. I agree with him that we were told one thing at the hearing on 28 October (namely, that Professor Hotopf was not prepared to continue his involvement with the case at all, principally, as I understood it, because of a potential conflict of interest given his current position) and that the position had changed by the hearing on 14 December. However, this is a forensic point that does not seem to me to have much substance. I am told now that Professor Hotopf is happy to continue his interest in the case (which he fully supports), but I sense that he has placed strong pressure on the Claimants’ team to limit the area of his involvement to epidemiology. I do not know why that should be so other than to draw what may be the legitimate inference that, whilst he has sufficient expertise to deal with the statistics, he would prefer not to have to deal with both statistics and epidemiology and thus have to deal with two separate experts on the Defendant’s side perhaps in light of his current workload. Mr Sheehan was concerned that the opportunity to cross-examine Professor Hotopf about the concession referred to in paragraph 56 above would be lost if the substitution occurred, but that point rather disappeared when Mr Fetto pointed out that Professor Hotopf had said exactly the same in his joint statement with his epidemiological counterpart and so it was a cross-examination point (if permitted) still available to Mr Sheehan.

[97]Again, I recognise the need to look at the consequences of this re-arranged portfolio when considering overall whether I should call a permanent halt to this litigation now, but I do not consider that there is much substance in the points made against the principle of allowing Professor Glyn Lewis to take over the statistics side of what otherwise Professor Hotopf would have dealt with.

[98]Finally, of course, if one was in an ideal litigation world (which I recognise one is not in this litigation), it would be more appropriate from the point of view of “equality of arms” to have individual experts in particular areas matched against an equivalent expert in the same area. The proposed substitutions have that effect.

[99]Whilst the substitution of experts is unusual, it is not unknown. I had to deal with the issue in Andrews, etc v Allen and Overy & Others

[2013] EWHC 4735 (Ch)

and, as I mentioned during the argument, during 2015 I was faced, in my capacity as Judge in Charge of the Queen’s Bench Civil List, with applications for adjournments because of the non-availability of a particular Consultant Paediatric Neurologist for whom the party seeking to call him would be looking for a substitute. Obviously, it is important for the court not to sanction pure “expert shopping”, but I do not detect that in the present case. For whatever reason, it is now five years since the case was due to be heard and it is not surprising that some changes are effectively being forced on the Claimants’ side (just as it would be on the Defendant’s side if the case is permitted to proceed). (iv) the effect on the litigation of changing experts

[100]Leaving aside for the moment the issue of disclosure (see paragraphs 106 - 109 below), the question arises of how the new experts would report. Mr Sheehan has made a number of critical observations of the suggestions that they might simply “adopt” their predecessor’s report. I do not think that this is a matter upon which I should comment because the experts will have to take their own course. They will doubtless be alive to the need to comply with the CPR Part 35 and to put forward their considered view on the issue or issues involved and not simply repeat, parrot-fashion, what was said by someone else in a previous report. Such an approach would not reflect their duty to the court and would be singularly unpersuasive in any event.

[101]As I have said, it is not for me to dictate, but I am going to assume, for the purposes of deciding whether to permit this litigation to proceed, that each new expert on the Claimants’ side would prepare a new report and that each existing expert who remains (i.e. Professor Hotopf and Professor Hughes) would simply update their previous reports if updating was necessary. I understand that Professor Healy has given reports in some of the litigation in the USA so there will doubtless be little surprise from the Defendant’s perspective in what he says. I do not know to what extent Professor Glyn Lewis will take a different view from that of Professor Hotopf on the issue of statistics, but his evidence (Mr Fetto tells me) will be focused solely on that area and, accordingly, I doubt that Professor Gibbons will be taken by surprise by it.

[102]The status of previous reports and/or joint statements for the purposes of any trial would be a matter for the trial judge and I do not think that I should comment upon that.

[103]What would be the costs implications of permitting the instruction of these new experts? That may depend to some extent on whether disclosure of any new material relevant to the issues that has emerged since the completion of the earlier disclosure exercise reveals significant new information. I will turn to that shortly (see paragraphs 106 - 109), but is it possible to assess the costs implications of simply changing the experts? Ms Caswell in her second witness statement said this:

“125. If permitted, the effect of the Claimants submitting new expert reports in respect of the 3 main expert disciplines of psychopharmacology, statistics and epidemiology, would be to take this action back to where matters stood at the exchange of witness evidence in July 2009. 126. To illustrate the costs on both sides that would be wasted as a result of such a course, I take 1 July 2009 as the starting point for the work undertaken on expert evidence (while noting that GSK and the Claimants clearly instructed several of their generic experts before that date). During that 11-month period from July 2009 to May 2010 (inclusive), the Claimants incurred costs of £2,525,895.65 (excluding VAT). In the same period GSK incurred costs of £2,838,753.45 (excluding VAT).”

[104]She goes on to suggest that “at least £2.8 million will be wasted [by the Defendant] if the Claimants' two main experts are replaced” and that the figure for the Claimants will be “£2.5 million”, with a further prediction that “the cost the parties to take to this matter to trial is likely to be a further £13.5 million”, a fair part of which would be attributable to the expert involvement. (Mr Fetto, who does not accept the accuracy of this figure says, quite rightly, that a large part of whatever the true figure may be would have been incurred in any event had the trial proceeded as originally planned and that what needs to be considered is the additional cost arising from the changed situation.)

[105]For reasons that will be apparent from what I said in paragraphs 101 - 104 above, I do not consider that the substitution of these experts would simply put this action back to where it was in July 2009. Even the need to identify a few more lead cases should not affect significantly the expert evidence on the generic issues. I do not doubt that there will be a need to cover some new ground or some of the old ground again, but to suggest (if this is the suggestion) that experts, solicitors and Counsel alike can simply charge on an hourly basis where much of the ground has already been covered would be quite unreasonable. To suggest that about £2.5m on each side would have been wasted if the new experts were substituted is not a contention I can accept. There would be a need for detailed scrutiny of precisely what was being charged and for what in the context of any new expert reports. Ms Caswell suggests that it may cost the Defendant between £350,000 and £500,000. Again, these figures seem to be put forward in terrorem. It is very difficult at this stage to judge what the additional cost may be, but I have already indicated that I do not think that the “real” additional work on the Defendant’s side should be as extensive (and thus as expensive) as is being suggested.

(v) further disclosure

[106]Mr Fetto made it clear that standard disclosure since the end of the last disclosure exercise would be sought. I do not see how that could be avoided if the litigation is to continue.

[107]Ms Caswell estimates that a budget in the range of £50,000 - £60,000 for Addleshaw Goddard’s time alone would have to be provided for to carry out what was required. She asserts that the Defendant “would not be undertaking a simple supplemental disclosure exercise … [but] … an entirely new search for hard copy and electronic documents created in the period since Autumn 2010.” She itemises the categories of disclosure as: i) Periodic Safety Update Reports in respect of Seroxat; ii) UK datasheets and the Summary of Product Characteristics; iii) Seroxat Patient Information Leaflets; iv) Patient Information Leaflets for SSRIs, SNRIs and other medicines; v) Summaries of Product Characteristics for SSRIs, SNRIs and other medicines; vi) Paroxetine Global Data Sheets; vii) Correspondence between GSK and the UK medicines regulators; viii) promotional material in respect of Seroxat; ix) Global Labelling Committee meeting minutes.

[108]She says that this exercise would be “disproportionate”.

[109]Having been able to identify the categories of documents so clearly, I am bound to say that I do not really understand why the exercise should be so onerous, particularly since there has been recent litigation around the world about Paroxetine and most of these documents must have been identified already. The true recoverable cost of any necessary additional work would be the subject of a detailed assessment by the court in due course if there was an order for costs in favour of the Defendant. (vi) the overall value of the claim

[110]There are now only just over 100 individual Claimants, about one quarter of the original cohort. If there was a legitimate “average value” of a claim for the original cohort, the overall claim now is potentially considerably less given the size of the current cohort. Mr Maskrey said on two occasions to the Senior Master (once on 9 July 2007 and again on 29 October 2008) that the individual claims were “relatively modest personal injury claims”. His junior, Mr Matthews, had said to Master Whitaker on 27 February 2008 that each of the individual claims was of “moderate value”. He said expressly that it was not a case where there were “multi-million pound claims”. It would seem from what Dr Richards has said in one of her statements that the Legal Services Commission took the average value of the claim at £20,000 (which, incidentally, she says was “inexplicable”), though Ms Caswell has calculated the average figure as £67,000 on the basis of the schedules of special damages put forward by Hugh James.

[111]If Ms Caswell’s figure is broadly accurate, the overall amount that might be recovered if these proceedings continue to trial and were successful on behalf of the Claimants would be in the region of £6.9m, plus general damages and interest.

[112]It is said on behalf of the Claimants that Ms Caswell’s estimated “average” value is artificial because the Defendant simply took the average of the special damages of the 10 erstwhile Lead Cases and multiplied that figure by the total number of Claimants. The point is made that the Lead Cases were not chosen by reference to value, but by reference to the need to embrace all of the issues identified at paragraph 19 above and were, accordingly, not necessarily representative of the value. Dr Richards has said that, for the purposes of the appeal concerning the Public Funding Certificate, another unrepresentative process (enforced because of time constraints) was adopted with a view to addressing the assumed £20,000 value per claim to which I have referred. Volunteers were sought and the intention was that the first 10 to volunteer (representing about 10% of the cohort) would be chosen to have their claims valued. She said this about what happened:

“It transpired that of the 10 Claimants selected, 2 did not complete their Schedules due to reasons of illness and holidays. The remaining 8 were interviewed by telephone. The results indicated a range of general damages between £37,775 - £91,138 and special damages between £000 - £643,613. Total damages ranged between £37,775 - £1,605,802. Interest was calculated in respect of 4 of these Claimants. The total value was £3,548,371, giving a mean average value per Claimant of £443,546.37.”

[113]As I have said, she recognises, however, that this is not a representative sample either.

[114]Against this background, it is extremely difficult to obtain a realistic “sense” of what the total damages might be for 100 plus Claimants if successful on the issue of liability. If some could show that taking Seroxat had left them with, in effect, a lifetime dependency upon it which has affected their ability to work that, but for taking it, would not have been affected, then a quite substantial claim might be advanced realistically. If, however, the claimed consequences are simply that it took a few months longer to withdraw from taking it than might have been the case with another anti-depressant, the claim would inevitably be modest. It would seem that Mr Maskrey and Mr Matthews had that kind of situation more in mind than anything higher up the scale of value.

[115]I will have to return to this in the overview that it is necessary to take. (vii) length of trial

[116]There has been debate about the length of the trial. The time estimate for the trial contemplated in early 2011 was three and a half months and the Claimants’ team have put forward various updated estimates which started at four weeks and would appear now to be seven weeks. This varying position has attracted criticism from Mr Sheehan.

[117]My initial reaction was that what had been agreed by the experienced teams at an earlier stage would be more likely to be correct. However, my attention had not been drawn specifically to the way the timetable for the trial had been put together. The timetable is appended to the order made by Mackay J on 28 September 2010 when all parties were contemplating that the trial would proceed. What was proposed was that every Monday should be a reading day for the judge and that “Maxwell hours” would apply to the days when hearings took place – in other words, that the sitting times should be 9.30 – 14.30 with a 30-minute break during that period (thus providing for four and a half hours sitting time each day). The timetable I have seen provided for 50 days of oral evidence with one day for opening oral submissions on both sides and four days of oral closing submissions. There was provision for two hours of evidence-in-chief for each of the principal experts essentially for clarification purposes.

[118]I do not, of course, suggest that this was not an appropriate timetable, but I question whether quite such an extended timetable would be required if(a) a daily transcript was provided (which I anticipate it would be) and

(b) a normal court sitting day was adopted on a 5-day week basis. Plainly, the trial judge would need a substantial period for reading into the case, but I simply question whether it is necessary to build in a one day reading day each week. I am inclined to think that, with yet further refinement of the issues, one could be looking at a trial requiring no more than 6-7 weeks of evidence. Provision would, of course, have to be made for the preparation of written closing submissions and then their delivery or clarification in oral form.

[119](viii) lead cases

[120]I was told that there were to be 10 lead cases. Indeed it is correct that in the early stages that was contemplated in the orders made: see, e.g., the order made by Master Whitaker on 27 February 2008. However, the final substantive order before trial (made by Mackay J on 28 September 2010) referred to the consideration of 6 lead cases at trial.

[121]For my part, I would have thought that a total of 6 would suffice. “Exemplar” cases may or may not truly assist in determining generic issues, but I do not see that reverting to 10 has any particular magic about it provided that the cases chosen do provide the court with appropriate material by which to evaluate the generic issues.

Conclusion/overview

[122]I am conscious that I have reviewed extensively the current state of affairs in this litigation without, in many respects, having come to a definitive conclusion on a number of aspects. I have found it difficult to do so for a number of reasons, but they are all derived from an essential tension that is palpable: the Defendant is anxious (it might be said, over-anxious) to stop this litigation in its tracks. The motivation may simply be a total conviction that there is, in effect, no case to answer and that it is wrong to be harassed with unmeritorious claims. Alternatively, it may derive simply from a desire not to have to face in this jurisdiction the kind of claims brought in the USA and elsewhere. It may, of course, be a combination of both. Whatever the motivation, Mr Sheehan’s skilful advocacy has been deployed to expose every actual or perceived weakness in the Claimants’ position. I do not say that critically at all, but the nature of his underlying instructions is clear.

[123]So far as the Claimants’ team is concerned, I sense that they are, to a degree, still engaged in a catch-up process with the result that not all loose ends concerning the future conduct of the litigation, if it is permitted, are tied up. What I am prepared to take at face value for present purposes is that there is ATE insurance to the figure £750,000 available to cover costs to be paid to the Defendant if the generic claim is unsuccessful and that there is something significantly more than £500,000 available to fund the future of the litigation on the Claimants’ side. I have to accept also, because this is what I have been told, that the opportunity to increase these figures in both respects exist. To that extent, there is the wherewithal to proceed further in the litigation which has support from reputable experts with relevant expertise and that there is the prospect of recovery of at least some of its reasonable recoverable costs by the Defendant if the claims fail or are discontinued.

[124]Just as the Defendant will see criticisms of Seroxat as ill-founded and sees the demonstration of that proposition to be of importance, so too each individual Claimant will see his or her claim as important, whether it is valued at a modest level or a more significant level. I am concerned about the information I have on that aspect of the case and, if this case is to go further, even by a staged process, I shall require further work to be carried upon it. However, as I have indicated, the case is one of importance to all parties.

[125]As I have observed previously, this is not a strike-out application or an application for summary judgment. I do not doubt that I could bring the proceedings to an end under my case management powers if I felt it right to do so, but I have to say it would be an unusual step to take, certainly in the context of the kind of information I have available at present. I do not consider that it is a step that I should take at this stage. That does not mean that it may not be a step that could be taken at a later stage nor does it mean that, if so advised, the Defendant may not apply for summary judgment at some stage. However, I wish to see how this case may develop in various stages before deciding whether it should be brought to a halt as an exercise in case management. I think I should say that I do not encourage a “State trial” at every stage of the process, but I will be concerned to see that some rigour has been applied to the matters I expect to be dealt with before I give any sanction to a further stage in the process.

[126]What I propose to do is to assume for present purposes (without fully so providing in an order or otherwise deciding finally) that the proposed expert changes on the Claimants’ side will take place. Prior to making the decision about whether I will sanction such changes, I want to see completed the process of standard disclosure from the date of the closure of the earlier disclosure process to date. I should like each of the proposed experts for the Claimants to indicate in the light of that disclosure and in the light of the material previously disclosed (plus any relevant published papers) how long they consider it will take to prepare their report (in other words, the number of hours to complete it rather than “it will take a couple of months”) and what they would propose to charge for doing so.

[127]I shall ask the Defendant’s experts to review any additional disclosure and ask them to say whether they will wish to add anything to their earlier reports. If so, I will wish to know what they believe they will need to charge for so doing.

[128]Once the experts on each side have given their assessment of the position at that stage to the solicitors who instruct them, there is to be a mutual exchange of these assessments. At the expiration of 14 days after that exchange, each party should have produced a written commentary on the position taken by the other party and this commentary, plus the assessments of the experts themselves, are to be lodged with the court (and sent to my Clerk electronically) for my consideration as a “papers exercise”. I may ask the Senior Costs Judge to nominate a costs judge to assist in my evaluation of the costs implications at that time.

[129]If I feel that the information is satisfactory, I will consider giving the Claimants’ experts the opportunity to prepare their reports with a view to them being lodged with the court and served on the Defendant. By then, the precise costs of producing the reports and the extent of those reports will be known. I will at that stage consider what, if any, steps I require the Defendant’s experts to take before any report or reports in response are prepared.

[130]At this stage I do not propose to go further, but it will be apparent that I wish to proceed on a step-by-step basis with a careful eye on the costs of each step. I do not intend to “micro-manage” this litigation, but I need to see to what extent certain crucial stages are capable of being achieved and at what cost before I can obtain a sense of how realistic it is that it can proceed.

[131]In addition to this, and during the period it is taking place, I shall want the Claimants’ advisers to take 4 cases from the 100 or so Claimants they represent and identify one as typical of the lowest category in terms of potential award of damages, another being the next level up from that level, the next one being the one above that and finally, the fourth, being the highest claim that in their view could be advanced. Each Claimant must be identified by name and a fully worked up schedule of damages (with as much supporting material as possible) should be prepared in relation to each. When those schedules have been prepared, they should be served on the Defendant’s solicitors who should produce, so far as possible, a response to the claims as advanced. I shall want to see these schedules and counter-schedules when the other material from the experts is placed before me.

[132]I shall require a witness statement from Mr Hanison or Dr Richards indicating their assessment of how many of the 100 cases are within the various categories of value to which I have referred.

[133]I appreciate that this may be seen as something of a repeat of the process envisaged by part of the order made following the hearing on 28 October 2015, but I believe it will give me a clearer appreciation of the true collective value of the claims of the individual Claimants than achieved by what was revealed following that order.

[134]Finally, I will invite the Claimant’s advisers to identify 2 further cases (i.e. in addition to the one on the Claimants’ side that remains alive) that, in their view, should be taken as lead cases and to say why they, plus the existing lead case, will enable the issues set out in paragraph 19 above to be determined. I will not ask the Defendant to do the same for the time being.

[135]I propose to appoint Fortitude Law as the Lead Solicitor under the GLO for the purposes of implementing the directions that will be made to carry into effect the steps I have indicated. I will have a greater appreciation of their ability to progress matters satisfactorily at the end of that process.

Timetable and the order

[136]I will invite the parties to discuss a timetable with a view to carrying out these steps. I am, of course, anxious not to prolong matters in view of the 5-year gap in anything substantive occurring in the litigation, but a step-by-step approach will, at least initially, dictate rather slow progress. I would like to think that all the steps I have referred to can be carried out within 3 months from the date of any order giving effect to these rulings. However, I will hear from the parties if there is disagreement.

[137]I should be grateful if Mr Fetto could produce a draft order giving effect to the approach I have set out above which he should invite Mr Sheehan to consider. APPENDIX 1 “…the situation with which I'm confronted today is not satisfactory, in my view. The position now is that there are 100 or so Claimants who wish to go ahead in this litigation, and I am told that funding arrangements are in place, but no details have been given so that I'm in a position to evaluate how realistic it is for this cohort of Claimants to continue with the claim that has effectively been stayed for something over four-and-a-half years. There are, as things stand, some formidable arguments advanced by the defendants as to why this case should not be permitted to proceed. But I do not consider it right for me to decide today whether those arguments should or should not prevail. The new team representing the cohort of Claimants to which I have referred has only been in existence as a properly constituted unit since Fortitude Law came into existence in July and I sense that they have been playing catch-up since then. It's easy to be critical, but the unit is a small one and does not match, in terms of resources, the team on the other side. There is undoubtedly further information that should be made available to me before I can come to a final conclusion on the issues that have been raised before me today. What I'm proposing to do, and I'm deliberately making no comments one way or the other on the merits of the arguments I've heard today, is to adjourn this case management hearing part-heard, to be relisted before me on a convenient date between 12 and 18 December with one day allowed …. [I then gave directions as to the further information required which then were reflected in the order subsequently drawn up: see Appendix 2] I'm proposing to say nothing more, other than that I am hoping that armed with the further information, I'll be able to make a decision. I shall obviously hear further argument certainly on any new material on the next occasion, but having given the matter the best thought I can today, I don't feel that it's right for me to come to a final conclusion. And as I say, the matter remains open, but those directions must be complied with.” APPENDIX 2 1. The Claimants’ solicitors shall, by 4 p.m. on Friday 27 November 2015, lodge with the Court and serve on the Defendant, a statement addressing, fully and precisely, the following matters:(a) The directions that the Claimants are seeking and the reasons for seeking those directions in relation to: (i) the selection and pleading out of new lead claims; and (ii) disclosure (in relation to the generic and individual cases).

(b) In relation to the 3 “consultants”, referred to in Fortitude Law’s letter of 16 October 2015, said to be fee-earners allocated to management of the claims on behalf of the Claimants: (i) Save for Dr Sarah-Jane Richards, confirmation of the professional qualifications of those fee-earners and, in particular, whether they are qualified to practise as solicitors in England and Wales; and (ii) Confirmation of the amount of time that each consultant has been engaged to provide and for how long.

(c) In relation to the Claimants’ funding arrangements and ATE insurance arrangements in respect of adverse costs orders, a detailed explanation of the reasons and underlying assumptions relied upon for contending that those arrangements provide “adequate” cover having regard to the parties’ costs incurred thus far and their likely future costs if the litigation proceeds to a trial of 3½ months. 2. The Claimants shall, by 4 p.m. on Friday 27 November 2015: (a) Issue and serve on the Defendant any application for permission to rely upon substitute experts in the disciplines of psychopharmacology, epidemiology and medical statistics. The applications shall, for the avoidance of doubt, be supported by a statement and shall identify the proposed substitute expert in each discipline as well as his relevant expertise and experience; and (b) Letters, written by each of the proposed substitute experts, shall be exhibited to the supporting statement to any application, which set out: (i) the documents and materials relevant to the subject-matter of their proposed reports that they have considered thus far; and (ii) their preliminary views on the questions that they will be asked to address, if permission were granted, in their reports. 3. The Claimants shall, by 4 p.m. on Friday 27 November 2015, lodge with the Court and serve on the Defendant any revised schedules of loss that have been prepared by Fortitude Law and any other schedules (whether revised or not) that have been prepared in relation to any other Claimants for whom Fortitude Law are acting. 4. There shall be a further Case Management Conference, before the Honourable Mr Justice Foskett, to be listed in the week 14-18 December 2015, with a time estimate of 1 day. 5. Fortitude Law shall, by 4 p.m. on 6 November 2015 write to Hugh James seeking provision of copies of the schedules of information prepared in relation to the Claimants set out in the Schedule to this Order. The letter shall state that the request is made at the behest of Mr Justice Foskett. Fortitude Law shall, by 4 p.m. on 6 November 2015, provide a copy of the letter to Hugh James to the Defendant’s solicitors. 6. Skeleton arguments shall be lodged with the Court and exchanged not less than 3 days before the further Case Management Conference. 7. Costs reserved.