Sandra Bailey and Others v Glaxosmithkline (Uk) Ltd
| Jurisdiction | England & Wales |
| Judge | Mr Justice Foskett |
| Judgment Date | 04 February 2016 |
| Neutral Citation | [2016] EWHC 178 (QB) |
| Docket Number | Case No: TLQ/15/1275 |
| Court | Queen's Bench Division |
| Date | 04 February 2016 |
[2016] EWHC 178 (QB)
IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
Royal Courts of Justice
Strand, London, WC2A 2LL
Mr Justice Foskett
Case No: TLQ/15/1275
Jacqueline A. Perry QC, Niazi FettoandTimothy Killen (instructed by Fortitude Law) for the Claimants
Malcolm Sheehan QC and Andrew Kinnier (instructed by Addleshaw Goddard LLP) for the Defendant
Hearing dates: 28 October 2015 and 14 December 2015
Introduction
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.
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 3 1/2 months, but the proceedings stalled shortly before trial in the circumstances to which I will refer below.
This judgment represents the conclusions I have reached concerning the issues raised.
Background
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.
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."
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').
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".
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.
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
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.
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.
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.
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
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.
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...
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