Sandra Bailey & Others v Glaxosmithkline UK Ltd
| Jurisdiction | England & Wales |
| Judge | Mrs Justice Lambert |
| Judgment Date | 09 May 2019 |
| Neutral Citation | [2019] EWHC 1167 (QB) |
| Docket Number | Case No: HQ07X04076 |
| Court | Queen's Bench Division |
| Date | 09 May 2019 |
[2019] EWHC 1167 (QB)
IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
Royal Courts of Justice
Strand, London, WC2A 2LL
Mrs Justice Lambert
Case No: HQ07X04076
Jacqueline Perry QC, Michael Kent QC, Niazi Fetto, Harry Lambert and Juliet Stevens (instructed by Fortitude Law) for the Claimants
Charles Gibson QC, Malcolm Sheehan QC, Andrew Kinnier QC, Adam Heppinstall and James Williams (instructed by Addleshaw Goddard) for the Defendant
Hearing dates: 29 April – 1 May 2019
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
Introduction
This is an action for damages, brought by a large number of Claimants, arising from their use of the drug, Seroxat (a prescription only antidepressant and one of a class of Selective Seratonin Re-Uptake Inhibitors, or SSRIs) which is alleged to be defective under section 3 Consumer Protection Act 1987 (“the Act”). The trial started on 29 April 2019 and is listed for 10 to 12 weeks. An issue arose during the course of the Claimants' Opening which required an urgent ruling. I therefore heard submissions on the point and circulated my decision on 2 May 2019 with reasons to follow. This judgment sets out my reasons.
The Claimants were represented by Ms Jacqueline Perry QC and Mr Michael Kent QC with Mr Niazi Fetto, Mr Harry Lambert and Ms Juliet Stevens, the Defendant by Mr Charles Gibson QC, Mr Malcolm Sheehan QC, Mr Andrew Kinnier QC with Mr Adam Heppinstall, and Mr James Williams.
Procedural Background
The litigation has a particularly long history, the Particulars of Claim having been drafted as long ago as 2007. The procedural history of the litigation has been set out in detail in the judgment of Foskett J of February 2016 and I do not repeat it here. I note at this stage only that, following the service of the Defence, a Group Litigation Order was made by Senior Master Whittaker in October 2008 listing 11 common or related issues of fact or law for determination at trial and that the litigation was proceeding along the usual lines until very shortly before the trial (which had been listed to take place before Mackay J in February 2011) when public funding was withdrawn on a merits basis. The effect of the withdrawal of public funding was that the trial was adjourned, and the action effectively stayed until it came back before the Court, this time before Foskett J, in 2015. During the hiatus of over four years a large number of the Claimants discontinued their claims, leaving only around 124 Claimants in the action. The remaining Claimants challenged unsuccessfully the decision to withdraw public funding but managed to obtain alternative funding. A new counsel team was instructed, led by Ms Jacqueline Perry QC.
The first question confronting Foskett J was whether the claim should be allowed to proceed given the reason for the trial in 2011 having been vacated and the prolonged interval before it had been restored before the Court. In his judgments of February 2016 and March 2017 Foskett J determined that the fair course was to allow the litigation to go forward, but only on the basis that the Claimants' case should remain as pleaded at the date of the vacated trial. I will return to those judgments later but pause here to note that Foskett J set out his analysis of the pleadings and the parties' respective cases in some detail in those two judgments as it was the necessary context for his handling of the case management issues which arose. He recorded in March 2017 that the accuracy of his earlier summary (in February 2016) of the essential nature of the case advanced on behalf of the Claimants was common ground between the parties. Neither ruling was the subject of appeal.
I was appointed trial judge in the Autumn of 2018. Two pre-trial reviews were conducted before me: in November 2018 and February 2019. Again, I will return to those hearings and the decisions which followed in due course.
The Pleadings:
The action is brought under the 1987 Act where, under section 3(1) a product is defective if the safety of the product is not such as persons generally are entitled to expect. Under section 3(2), in determining what persons generally are entitled to expect, all of the circumstances shall be taken into account.
The issue which has arisen during the course of the Claimants' Opening concerns the scope of the Claimants' case on the pleadings; specifically whether, in determining whether the safety of the drug is such as persons generally are entitled to expect under section 3 of the Act, the Court should infer or assume that Seroxat has no relative benefits (when compared with other drugs in the appropriate comparator class). The Claimants submit that the Court should assume “a level playing field” (as it was put) of risks and benefits as between the drugs in the appropriate comparator class save for the single product characteristic of Seroxat which is said to constitute the “defect.” They submit that this inference or assumption arises from the parties' respective cases on the pleadings. This is disputed by the Defendant.
I set out below the key sections of the pleadings.
The Particulars of Claim (dated December 2007) identify the Claimants' generic case on defect in paragraphs 5 and 12:
“ 5. The Claimants contend that:
5.1 the Product was defective as defined in the Directive and the Act because the safety of the Product was not such as persons generally were entitled to expect in that the capacity of the Product to cause adverse effects consequent upon or following discontinuance (withdrawal) was such as to prevent or make more difficult the ability of users to discontinue, withdraw from or remain free from taking the Product, to an extent greater than other SSRIs;
5.2 (a) the adverse effects, and (b) the need to continue taking the Product, amount to a personal injury.”
At paragraph 12 the defect alleged is stated to be that:
12.1 the Product had the capacity to cause adverse effects on discontinuance (withdrawal) which were injurious and which were such as would prevent or make it more difficult to withdraw from, discontinue or remain free from taking the Product;
12.2 the capacity of the Product to cause such adverse effects was greater than with other SSRIs;
12.3 persons generally are and were at all relevant times concerned about whether antidepressants were
“addictive” in the sense that, amongst other things, it could be difficult to discontinue taking the medication… Accordingly, persons generally are and were entitled to expect that:
12.3.1 the Product would not be marketed or sold, or further marketed or sold until any such adverse effects on discontinuance that were identified as potentially present in pre-marketing trials or post-marketing surveillance studies had been fully assessed as to their nature, incidence and extent;
12.3.2 the Product would not have the potential to cause such adverse effects upon discontinuance in terms of incidence or severity as would make it difficult to discontinue taking the medication;
12.3.3 the Product would be no more likely to cause such adverse effects upon discontinuance than other SSRIs which could be prescribed for the same condition;
12.3.4 insofar as there was therapeutic benefit available from the Product not available from any other SSRI (which in respect of the main indications for which the same was marketed is denied) and
12.3.4.1 in any event, the Product would carry a clear warning in relation to adverse effects upon discontinuance…
Before serving its Defence, the Defendant requested clarification of a number of sections of the Particulars of Claim. The Request included the following:
“6. In contending that Seroxat was defective for the reasons alleged in paragraph 5.1 of the Particulars of Claim, is it the Claimant's case that the benefits of Seroxat against other SSRIs for a particular Claimant are material or to be taken into account?”
7 If so: (a) is it contended that Seroxat had lesser benefits for every Claimant than other SSRIs?; (b) please identify each benefit and each SSRI being referred to?”
Question 6 was answered: “No.”
Question 7 (a) was answered “ Strictly, given the answer to 6, an answer is not required. However, in the event that potential benefit is determined to be of relevance, the Claimants denies (sic) that the Product had or has any or any greater effectiveness or other substantial benefit when compared with other SSRIs”
The Defence was served in September 2008. The Defence challenged the lawfulness of the Claimants' approach to defect under section 3 of the Act. At paragraph 39 it was pleaded that:
“39. For the avoidance of doubt, it is denied that a defect within the meaning of the 1987 Act, in a prescription-only medicine can be established by comparing the incidence and/or severity of a particular adverse reaction associated with that medicine against the incidence and/or severity of that adverse reaction associated with another prescription-only medicine. The producer of a prescription-only medicine cannot properly compare its medicine with all other comparator medicines either at the stage of development, post marketing or in its product literature.”
The Defence then set out what the Defendant asserted to be the lawful approach to defect in paragraph 40:
“40. Without prejudice to the foregoing denial, it is averred that any proper comparison between medicines would have to include a comparison of the relative risk/benefit profiles of the medicines being compared, both generally and for the particular Claimant in question. Such an analysis would...
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