Bailey and Others v Glaxosmithkline
| Jurisdiction | England & Wales |
| Judge | Lord Justice Hamblen,Lord Justice Peter Jackson,Sir Ernest Ryder |
| Judgment Date | 08 November 2019 |
| Neutral Citation | [2019] EWCA Civ 1924 |
| Court | Court of Appeal (Civil Division) |
| Docket Number | Case No: B3/2019/1265 |
| Date | 08 November 2019 |
[2019] EWCA Civ 1924
IN THE COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
THE SEROXAT GROUP LITIGATION
The Honourable Mrs. Justice Lambert DBE
CLAIM NO. HQ07X04076
Royal Courts of Justice
Strand, London, WC2A 2LL
THE SENIOR PRESIDENT OF TRIBUNALS
Lord Justice Hamblen
and
Lord Justice Peter Jackson
Case No: B3/2019/1265
Michael Kent QC, Niazi Fetto, Harry Lambert & Juliet Stevens (instructed by Fortitude Law) for the Appellants
Charles Gibson QC, Malcolm Sheehan QC, Adam Heppinstall, James Williams (instructed by Addleshaw Goddard LLP) for the Respondent
Hearing date: 31 October 2019
Approved Judgment
Introduction
This appeal concerns an action for damages for personal injury brought by the appellant Claimants in which it is alleged that Seroxat, a prescription-only antidepressant and one of a class of Selective Serotonin Re-Uptake Inhibitors or SSRIs, is defective within the meaning of the Consumer Protection Act 1987 (“the CPA”).
The Claimants appeal against the decision of the trial judge, Lambert J, as to the scope of the Claimants' case on defect. In summary, she held that that case was limited to the risks of Seroxat relative to comparator SSRIs in respect of symptoms on discontinuation (the “worst in class” case) and could not be extended to the relative risks and benefits of Seroxat and its comparators more generally (“the risks/benefits case”). In consequence she held that, in considering whether the safety of Seroxat is such that persons generally are entitled to expect, the Claimants were not entitled to advance the case that Seroxat has no particular benefits relative to other drugs in the appropriate comparator group.
As a result of this ruling the ten week trial was adjourned pending determination of any appeal. Her ruling is set out in a reserved judgment of 9 May 2019, [2019] EWHC 1167 (QB) (“the judgment”).
The legal framework
The CPA is the United Kingdom's implementation of the Product Liability Directive 85/374/EEC (“the Directive”).
The Directive created a no-fault liability regime for defective products. Producers of products are liable for injury to persons or damage to certain kinds of property if a claimant can establish that the loss was caused by “a defect in the product”.
Section 3 of the CPA sets out when there is a “defect in the product”. It provides as follows:
“(1) Subject to the following provisions of this section, there is a defect in a product for the purposes of this Part if the safety of the product is not such as persons generally are entitled to expect; and for those purposes “safety”, in relation to a product, shall include safety with respect to products comprised in that product and safety in the context of risks of damage to property, as well as in the context of risks of death or personal injury.
(2) In determining for the purposes of subsection (1) above what persons generally are entitled to expect in relation to a product all the circumstances shall be taken into account, including—
(a) the manner in which, and purposes for which, the product has been marketed, its get-up, the use of any mark in relation to the product and any instructions for, or warnings with respect to, doing or refraining from doing anything with or in relation to the product;
(b) what might reasonably be expected to be done with or in relation to the product; and
(c) the time when the product was supplied by its producer to another;
and nothing in this section shall require a defect to be inferred from the fact alone that the safety of a product which is supplied after that time is greater than the safety of the product in question.”
In determining whether a product fails to meet the entitled expectations of persons generally, section 3(2) accordingly provides that “all the circumstances shall be taken into account” and sets out a list of non-exhaustive factors which the Court is required to take into account.
Recent guidance as to the interpretation of section 3 is provided by the decision of Hickinbottom J in Wilkes v DePuy International Limited [2018] QB 627. In that case he held at [78] that “assessment of whether the safety of a product is at an acceptable level requires a holistic approach.” On the question of whether risk/benefit is a relevant circumstance Hickinbottom J held that “any assessment of its safety will necessarily require the risks involved in use of that product to be balanced against its potential benefits including its potential utility” and that “risk-benefit may lie at the heart of the question of appropriate level of safety of a medicinal product for the purposes of the Act”.
The pleaded case on defect
At paragraph 5 of the Particulars of Claim dated December 2007 (“the POC”) the Claimants contended how the product was allegedly defective:
“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 (emphasis added);
5.2 — (a) the adverse effects, and (b) the need to continue taking the product, amount to a personal injury.”
At paragraph 12 of the Particulars the defect alleged was 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 mediation… 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 in 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 SSRI's 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 in any event,
12.3.4.1 – the Product would carry a clear warning in relation to adverse effects upon discontinuance…”
(emphases added).
Before serving its Defence, the respondent Defendant requested clarification of the POC in a Request for Further Information dated 19 February 2008. The Claimants provided a Reply to the Request for Further Information on 23 May 2008. The answers given to Questions 6 and 7 are of particular relevance:
“Question 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?”
To this question 6, the Claimants answered: “ No.”
“Question 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?”
To question 7 (a), the Claimants 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.”
To question 7 (b), the Claimants answered: “No answer required, given the answer to 6”
(emphases added)
In relation to paragraph 12.3.4.1. there was the following Question and Answer:
R: “Is it the Claimants' contention that even if there were therapeutic benefits available from Seroxat not available from any other SSRI, Seroxat should have carried the warnings identified at paragraphs 12.3.4.1 to 12.3.4.3?
A: This is irrelevant but the answer is yes.” (emphasis added)
Following this exchange, the Defence was then served on 15 September 2008. This challenged the lawfulness of the Claimants' approach to defect, pleading at paragraph 39 as follows:
“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 Defendant's case as to the lawful approach to defect was set out at paragraph 40 as follows:
“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...
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