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You are here: BAILII >> Databases >> Scottish Court of Session Decisions >> RICHARDS, (FIRST) ; AND (SECOND JOHN JARVIE AGAINST PHARMACIA LIMITED, c/o PFIZER LIMITED [2018] ScotCS CSIH_31 (24 April 2018)
URL: http://www.bailii.org/scot/cases/ScotCS/2018/[2018]_CSIH_31.html
Cite as: [2018] CSIH 31, [2018] ScotCS CSIH_31
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SECOND DIVISION, INNER HOUSE, COURT OF SESSION
Lord Justice Clerk
Lord Brodie
Lord Malcolm
[2018] CSIH 31
A256/10 & A273/10
OPINION OF THE COURT
delivered by LORD BRODIE
In the cause
(FIRST) RONALD RICHARDS; and (SECOND) JOHN JARVIE
Pursuers and respondents
against
PHARMACIA LIMITED, c/o PFIZER LIMITED
Defenders and reclaimers
Pursuer: Smith QC, Murray; Lefevre Litigation
Defender: Shand QC, Middleton; DWF LLP
24 April 2018
Introduction
[1] This is a reclaiming motion at the instance of the defenders against an interlocutor of
the Lord Ordinary (Lord Beckett) dated 12 May 2017 allowing proof in two actions, one at
the instance of Ronald Richards, the other at the instance of John Jarvie. In so far as material
to the points which were canvassed before Lord Beckett, the pleadings in the respective
actions are almost identical (and certainly intended to be identical). For that reason, having
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heard what he describes as in effect one debate on parties’ preliminary pleas in the two
actions, the Lord Ordinary issued one opinion. We shall follow his example.
[2] As the Lord Ordinary explains in his opinion, these actions are among a number (he
mentions a figure of over sixty, we were advised that the number might be about seventy) of
actions before the court in which the defenders are being sued in connection with their
production, marketing and distribution of the non-steroidal anti-inflammatory drug
(“NSAID”) celecoxib, manufactured and marketed under the proprietary or brand name of
Celebrex. In these two cases the pursuers aver that they each suffered a serious adverse
cardiovascular (“CV”) event as a result of being prescribed and thereafter ingesting
Celebrex. Both pursuers found on fault at common law and separately aver that Celebrex
was a defective product giving rise to liability for damage caused, in terms of section 2 of the
Consumer Protection Act 1987. It is averred that the defenders are the corporate successors
of certain companies in the United Kingdom and in the United States which participated in
the research, development and marketing of Celebrex. We were advised during the hearing
of the reclaiming motion that Pharmacia Limited is owned by Pfizer Limited and that it has
a marketing function within the Pfizer group of companies (the matter is addressed in
answers 2.3.1 and 2.3.2). Nothing now turns on precise corporate identity. It is accepted
that the pursuers have sued the appropriate defenders. Thus, in the pleadings and in this
opinion the expression “the defenders” comprehends all such companies (including
companies incorporated outwith the United Kingdom) as had, at the relevant time,
responsibility for the acts and omissions relied upon by the pursuers as giving rise to
liability to make reparation to them.
[3] Celebrex 100 mg and 200 mg capsules received marketing authorisation in the
United Kingdom in May 2000. Mr Richards took Celebrex as prescribed between July 2002
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and May 2004. Mr Jarvie took Celebrex as prescribed between May 2002 and December
2004.
[4] A number of acronyms appear in this opinion. They are listed with an explanation of
what the letters stand for in the appendix.
Procedure
[5] Rule 2.2 of the Rules of the Court of Session empowers the Lord President, where he
is of the opinion that an aspect of the procedure which would otherwise apply to particular
proceedings, or proceedings of a particular description, is unsuitable for the efficient
disposal of those proceedings, to direct that that aspect of the procedure is not to apply in
respect of those proceedings and that such other procedure as he directs is to apply instead.
Such a practice direction was made on 23 September 2010 in respect of actions of which the
actions at the instance of Mr Richards and Mr Jarvie are examples. It is “Practice Direction
No 2 of 2010: Personal Injury Actions relating to the drugs Vioxx and Celebrex”. It relates
both to actions already raised as at 23 September 2010 and to actions raised subsequently
(“new actions”).
[6] Among other provisions, Practice Direction No 2 of 2010 provides that chapter 43 of
the Rules of Court shall not apply and that a new action shall be raised as an ordinary
action. The action at the instance of Mr Richards and the action at the instance of Mr Jarvie
had been raised prior to the making of the practice direction. The actions therefore became
subject to the practice direction on 23 September 2010 but its provisions were to an extent
anticipated on 26 May 2010 when on the motion of the pursuers of consent these two actions
were withdrawn from the procedure under chapter 43 of the Rules of Court, appointed to
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proceed as ordinary actions and sisted “pending consideration of further procedure in this
and related cases.”
[7] The objective of Practice Direction No 2 of 2010 can be seen from its paragraph 11:
“The court will manage the actions with the aim of securing the efficient disposal of them.”
To that end the court was given the powers set out in paragraph 12 and 13. These powers
include, either acting on the court’s own initiative or on the motion of one or more parties:
power to determine future procedure; power to set timetables; power to order disclosure of
information; power to order production and recovery of documents; and power to order
production of expert reports and affidavits. Paragraph 14 provides that where reasonably
practicable the court’s management function will be discharged by a particular Lord
Ordinary. Mr Smith QC, who has represented the pursuers from the beginning of these
litigations and who appeared before us, observed that the making of Practice Direction No 2
of 2010 was comparable to the making of a group litigation order in England, as provided
for by Civil Procedure Rule 19.11 (as to which see Blackstone’s Civil Practice 2017 para. 14.66
et seq). We have noted that information but, for present purposes at least, nothing would
appear to arise from it.
[8] Consideration of the 35 or so interlocutors pronounced in Mr Jarvie’s action between
the making of the practice direction and the action coming before Lord Beckett for debate in
March 2017 does not suggest that this and the other actions subject to Practice Direction
No 2 of 2010 have proved capable of very efficient, at least in the sense of swift, disposal.
The Minute of Proceedings points to difficulties over disclosure of information and recovery
of documents, a matter alluded to by Mr Smith. Mr Smith was able to provide some
additional information. In 2010 the “related cases” included actions against Merck Inc.
arising out of the prescription of a similar drug to Celebrex which was marketed under the
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proprietary name of Vioxx. Merck had initially taken the lead in presenting a defence to
what at one point had been in excess of 200 cases. Some of these cases involved pursuers
who had been prescribed both Celebrex and Vioxx. The Merck cases eventually settled. The
cases against the defenders have not. By interlocutor of 9 July 2012, in discharge of a duty
imposed by paragraph 15 of the practice direction to give early consideration as to whether,
in order to determine or give guidance on any generic issue in the actions, it is appropriate
to identify a lead action or actions to be progressed at an advanced rate, the actions at the
instance of Mr Richards and Mr Jarvie, together with one other action, were appointed to be
lead actions. That of Mr Richards was selected to represent the cases where the pursuer had
suffered a heart attack. That of Mr Jarvie was selected to represent the cases where the
pursuer had suffered a stroke. The third action was one where the pursuer (who has
subsequently died) had been prescribed both Celebrex and Vioxx. The pleadings in the lead
actions were adjusted with a view to encompassing what were seen to be the common issues
over the whole group of Practice Direction No 2 of 2010 cases. On 7 July 2016 the action at
the instance of Mr Richards and that at the instance of Mr Jarvie were appointed to a
Procedure Roll debate.
Regulatory approval of medicinal products
[9] These actions are concerned with the safety or otherwise of medicinal products
available only on prescription. Parties’ respective averments make reference to the process
for the regulation of medicinal products and in particular the interaction between the
defenders and the authorities responsible for marketing authorisation. That process
provides the broad context of the litigations and their pleadings and it might therefore be
useful at this stage to say something about it.
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[10] As appears from the pleadings, medicinal products may not be placed on the market
anywhere in the EU unless they have been granted an appropriate licence or marketing
authorisation. The same is true in the United States of America. We were referred to
Powers & Barton, Clinical Negligence (5th edit) paras 13.1 to 13.54 for a summary of the
regulatory framework for medicines in the United Kingdom. The fifth edition of Powers &
Barton was published in 2015 and the text reflects the position as at that date, but it also
touches on the history of regulation. This allows a broad understanding of the regime which
was in force when the pursuers in these two actions were being prescribed Celebrex.
[11] The methodical implementation of mechanisms to promote the efficacy and safety of
medicinal products may be referred to as “pharmacovigilance”. Powers & Barton describe
pharmacovigilance within the EU as a tri-partite operation. By that they mean that (1) EU
institutions, (2) the competent authorities of Member States and (3) the parties authorised to
market medicinal products (“marketing authorisation holders”) all have responsibilities in
the matter, both at the stage of application for necessary regulatory approvals and thereafter.
As counsel confirmed before us, although the fact that Celebrex had all necessary regulatory
approvals in the United Kingdom is relevant to a consideration of the issues in these and the
other Practice Direction No 2 of 2010 cases, it is not suggested that regulatory approval can
absolve the defenders of their responsibilities in relation to the marketing of the drug.
[12] At the European level, pharmacovigilance has a history extending back to at least
26 January 1965 and the adoption of Council Directive 65/65/EEC on the approximation of
provisions laid down by law, regulation or administrative action relating to proprietary
medicinal products. Further provision was made by Council Directives 75/318/EEC and
75/319/EEC. Article 50 of Council Regulation (EEC) 2309/93 established the European
Agency for the Evaluation of Medicinal Products (“EMEA”). The EMEA comprised the
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Committee for Proprietary Medicinal Products (“CPMP”), the Committee for Proprietary
Veterinary Products, a secretariat, a director and a management board. The CPMP was
responsible for the preparation of the opinion of the EMEA on any question relating to the
evaluation of medicinal products for human use. That structure was superseded on
implementation of Regulation (EC) 726/2004 of the European Parliament and Council of
31 March 2004. In place of the EMEA there was established the European Medicines
Agency. There was also established, as part of the Agency, the Committee for Medicinal
Products for Human Use (“CHMP”). The CHMP assumed the responsibilities of the former
CPMP. Despite being re-established as the European Medicines Agency, Powers & Barton
tell us (at para 3.18 (1)) that the Agency retained the acronym EMEA until December 2009. It
is now however referred to as the EMA.
[13] Among the functions of the EMA is the issue of marketing authorisation for a
number of specified medicinal products, but more generally the issue of marketing
authorisation remains a matter for the competent authorities of the Member States. In the
United Kingdom the competent authority is (and at all relevant dates has been) the
“licensing authority” provided for by section 6 of the Medicines Act 1968. The licensing
authority is a body composed of the Ministers specified in section 1 of the 1968 Act. As
Powers & Barton explain at para 13.19, the licensing authority carries out its executive
functions through a body (“the regulatory authority”) which was created for the purpose of
regulating all the activities related to human medicinal products in the United Kingdom
including the grant, renewal, variation, suspension and revocation of licenses and
certificates. The regulatory authority was originally a branch of the then Department of
Health and Social Security and was known as the Medicines Division. The Medicines
Division was reorganised in April 1989 into an agency known as the Medicines Control
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Agency (“MCA”). The MCA was the regulatory authority (and therefore, from the
European perspective, the competent authority of the United Kingdom as a Member State)
from April 1989 until April 2003 when it was again reorganised following a merger with the
Medical Devices Agency as the Medicines and Healthcare Products Regulatory Agency
(“MHRA”).
[14] Until 2012 the statutory framework for the domestic regulation of medicinal
products was provided by the Medicines Act 1968 as amended by the Medicines Act 1971.
Provision was made for the grant and renewal of product licences, manufacturer’s licenses
and wholesale dealer’s licences, without which the relevant activity was prohibited. Section
18 of the 1968 Act provided that applications for licences should be accompanied by such
information as may be prescribed by subordinate legislation. In 2012 much, although not
all, of the 1968 Act was repealed and its provisions relating to the regulation of medicinal
products replaced by provisions of the Human Medicines Regulations 2012, SI 2012/1916.
[15] In the United Kingdom the regulatory function is supplemented by the advice given
to Ministers and the licensing authority by advisory committees established under the 1968
Act. One such was the Committee on Safety of Medicines (“CSM”). The CSM was replaced
in 2005 by the Commission on Human Medicines (“CHM”). The functions of the CHM are
now set out in article 10 of the 2012 Regulations.
[16] While regulation of medicinal products is, and at all relevant dates has been, within
the competence of Member States and therefore in the United Kingdom a matter for the
licensing authority acting through the regulatory authority for the time being, that regime
has of course been subject to the relevant European measures. Directive 2001/83/EC of the
European Parliament and of the Council, dated 6 November 2001, provided a detailed and
extensive Community Code Relating to Medicinal Products for Human Use. Article 6 of the
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Directive provides that no medicinal product may be placed on the market of a Member
State unless a marketing authorisation has been issued by the competent authorities of that
Member State or an authorisation has been granted by the EMA in accordance with
Regulation (EEC) 2309/93. The marketing authorisation holder shall be responsible for the
marketing of the medicinal product. In terms of article 8 of the Directive the application for
marketing authorisation submitted to a competent authority must be accompanied by
certain particulars and documents. The particulars and documents include therapeutic
indications, contra-indications and adverse reactions; the results of pharmaceutical tests,
pre-clinical tests and clinical trials; a Summary of Product Characteristics (“SPC”) in
accordance with article 11; a mock-up of the outer packaging containing the details provided
for in article 54 and of the immediate packaging of the medicinal product containing the
details provided for in article 55; and a package leaflet in accordance with article 59.
[17] Powers & Barton say this of SPCs (at paras 13.30 and 13.33):
“13.30 The data sheet or summary of product characteristics (SPC) is designed and
intended to provide the physician with the key information necessary for the safe
and effective use of the medicine. Critically it is a dynamic document that evolves
with time as experience with the wider use of the medicine concerned increases and
better defines its efficacy and safety and any population at risk. For all practical
purposes, it is the most important regulatory document relating to a medicinal
product.
…
13.33 Copies of SPCs are made available to healthcare professionals from reference
sources such as the Association of the British Pharmaceutical Industry (ABPI) Data
Sheet Compendium or monographs which are usually updated annually. In
addition, since 1999 SPCs and PILs (see below) have been available to healthcare
professionals online at a dedicated website updated daily known as the electronic
Medicines Compendium. All information on the website is provided by
pharmaceutical companies and is approved by the regulatory authorities.”
[18] The acronym “PILs” which appears in para 13.33 of Powers & Barton refers to
Patient Information Leaflets, otherwise package leaflets as provided for by article 59 of the
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Directive. Article 59 provides that the PIL shall be drawn up in accordance with the SPC.
Certain information must appear in the PIL. This includes contra-indications, appropriate
precautions for use and special warnings. Powers & Barton provide this commentary on
PILs at paras 13.34 and 13.35:
“13.34 A patient information leaflet (PIL) is ‘a leaflet containing information for the
user which accompanies a medicinal product’ which provides the patient with the
key information necessary for the safe and effective use of the medicine. It is not
promotional. The language must be simple and non-technical, easily readable and
readily understood by lay people. The amount of information that is included calls
for a delicate balance between the provision of adequate information to support
patients using the medicine appropriately and excessive information which may
dilute other important messages in the text. Furthermore, the wording of the PIL
should encourage appropriate use and adherence to treatment without giving rise to
anxiety or unnecessarily frightening the patient.
13.35 With changing attitudes to the provision of information directly to the
patients, PILs have, over the years, become progressively more detailed. …Over
time, as increased weight has been placed on the active involvement of patients in
decisions regarding their own health, there has been a trend towards the provision of
more detailed information in PILs. The current requirements are set out in the
Human Medicines Regulations 2012, Part 13, together with Schs 24 and 27.”
[19] The adoption of Directive 2001/83/EC and with it the Community Code Relating to
Medicinal Products for Human Use, post-dates the issue of marketing authorisation for
Celebrex but, at least in part, the Directive’s provisions reflect pre-existing European
measures. SPCs and PILs are not of recent provenance. Provision for the contents of SPCs
was made by the amendment to Council Directive 65/65/EEC effected by Council Directive
83/570/EEC of 26 October 1983. There is reference to a package leaflet in the original text of
the 1965 Directive.
[20] As Powers & Barton’s reference to the SPC as a “dynamic” document illustrates, the
process of communication between those marketing medicinal products and the licensing
authority is not expected to come to an end on the grant of a marketing authorisation. This
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is addressed in title IX (articles 101 to 108) of Directive 2001/83/EC. Powers & Barton
provide this short summary of the relevant provisions at para 13.18 (3):
“The marketing authorisation holder must operate its own pharmacovigilance
system, evaluate all information scientifically, consider options for risk minimisation
and prevention and take appropriate measures as necessary: including, inter alia, an
appropriately qualified person responsible for pharmacovigilance; a
pharmacovigilance master file; and a risk management system for each medicinal
product, monitoring and updating the risks.”
The pursuers’ cases
Celebrex
[21] Inflammation of tissue is productive of pain. Inflammation and its associated pain
can become chronic, as is the case with, for example, osteoarthritis and rheumatoid arthritis.
These conditions are widespread, particularly in more elderly populations. NSAIDs reduce
inflammation by blocking the action of a protein that acts as an enzyme, cyclo-oxygenase 2
(“COX-2”). However, traditional or standard NSAIDs, such as Aspirin or Ibuprofen, also
block the action of another protein that acts as an enzyme, cyclo-oxygenase 1 (“COX-1”), a
catalyst for the production of prostaglandins which promote the production of the natural
mucus lining which protects the stomach. The blocking or suppression of COX-1 can
therefore result in harmful gastro-intestinal effects, including the development of ulcers and
internal bleeding.
[22] In about 1991 a method was discovered of producing a NSAID which would
suppress only COX-2 thereby avoiding the adverse consequences of suppressing COX-1.
Such NSAIDs may be described as COX-1 sparing analgesics, or as selective COX-2
inhibitors. Among these was one developed by the defenders (or at least the rights to which
were acquired by the defenders) which had as its generic name celecoxib and which was
marketed as Celebrex. Another such NSAID was developed by Merck Inc. and was
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marketed as Vioxx. The defenders also acquired the rights to a similar COX-1 sparing
analgesic with the proprietary name of Bextra.
[23] On 29 June 1998 the defenders applied to the United States Center for Drug
Evaluation and Research for approval to market Celebrex in the United States under
reference number NDA 20-998. The proposed indication for use of the drug was treatment
of the symptoms of osteoarthritis and rheumatoid arthritis. The application stated that
celecoxib had greater efficacy and safety than currently available NSAIDs.
[24] The first marketing authorisation for Celebrex in the EU was granted by the Swedish
Medical Products Agency on 3 December 1999. As noted above, Celebrex 100mg and 200mg
capsules received marketing authorisation in the United Kingdom in May 2000. The
relevant marketing authorisation numbers were PL 08821/0057 and PL 08821/0058
respectively. Celebrex first appeared in the British National Formulary in September 2000
(volume 40).
[25] On 30 September 2004 Vioxx was withdrawn from the market. In November 2004
the defenders included a “black box warning” in the PIL for Bextra. A black box warning is
the highest level of warning that can be inserted prior to a product being withdrawn from
the market. On 7 April 2005 a Pfizer company agreed to insert a black box warning on the
Celebrex label in relation to products marketed in the United States. It stated: “Celebrex
may cause an increased risk of serious cardiovascular thrombotic events, myocardial
infarction and stroke which can be fatal.”
[26] Celebrex continues to be authorised to be marketed in Scotland and throughout the
EU.
Injury
[27] Mr Richards was born in 1944. He has a medical history of soreness and stiffness in
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his joints albeit he has enjoyed an active lifestyle. In 1996 he was referred to a rheumatoid
clinic but, after testing, no diagnosis was made. He had been prescribed various painkillers
for his condition, including Voltarol, Diclofenac and Naproxen. On or about 3 July 2002 he
was prescribed Celebrex by his general medical practitioner. The prescribed dosage was
200 mg per day. His GP explained to Mr Richards that Celebrex was a new drug and that
there had been positive reports about it. He said that Mr Richard’s dose of Naproxen was
getting too high and that it did not work as well as Celebrex did. Mr Richards accepted the
advice to take Celebrex. In the event, Celebrex was effective in treating his joint soreness
and stiffness. Mr Richards took it every day. On 12 May 2004, he suffered a heart attack.
[28] Mr Jarvie was also born in 1944. He has long-standing cervical and lumbar
spondylosis. He was medically retired from work as a coal miner in 1990 as a result of that
condition. He regularly took analgesia for back pain. He had oesophagitis. He was advised
not to take Diclofenac. On 4 January 2001, Mr Jarvie was examined by his GP. His GP
prescribed Vioxx. At a review on 1 February 2001, Mr Jarvie complained that Vioxx caused
him bloating. The prescription was not renewed. On or about 3 May 2002, Mr Jarvie saw
his GP. He had pain in his left arm, elbow and shoulder. At a further consultation on
31 May 2002, the GP prescribed Celebrex. Mr Jarvie took the prescribed dose of 200 mg
Celebrex each day between 31 May 2002 and 3 December 2004. He found Celebrex to be
helpful in moderating his pain. On 21 November 2003 Mr Jarvie suffered a stroke. He
suffered a second stroke on 11 May 2004.
[29] The pursuers have averments (at statement 2.6) of the mechanism whereby selective
inhibition of the COX-2 enzyme can lead to a CV event. Selective inhibition interferes with
the production and operation of prostacyclin rendering the formation of blood clots more
likely. Prostacyclin acts to prevent platelet formation and the clumping that is involved in
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clotting. Increased risk of clots causes an increased risk of stroke or myocardial infarction.
As was confirmed to the Lord Ordinary during the debate before him, it is the pursuers’
position that the ingestion of Celebrex over a significant period caused (in the sense of
materially contributed to), in Mr Richards’s case, his heart attack on 12 May 2004 and, in
Mr Jarvie’s case, his strokes on 21 November 2003 and 11 May 2004. Before the Lord
Ordinary counsel for the defenders stated that he apprehended that the pursuers would
attempt to prove causation of injury on an analysis comparable to that approved by the
increase in risk being sufficient to satisfy the causal requirements for liability) but counsel
for the pursuers explicitly disclaimed any such intention. Mr Smith confirmed that position
before us. The pursuers accept that they will have to satisfy the onus of establishing that the
particular adverse CV events affecting them were, on a balance of probabilities, caused (on a
“but for” basis) by their long-term ingestion of Celebrex.
Liability
[30] The pursuers’ case is of failure on the part of the defenders to provide adequate
information as to a material risk of the association of adverse CV events with long-term
consumption of Celebrex. It is presented on two bases: (1) negligence; and (2) liability for
damage by virtue of section 2 (1) of the Consumer Protection Act 1987. Immediately
following the averments at statement 2.6 as to the mechanism whereby ingestion of selective
COX-2 inhibitors such as Celebrex may lead to an adverse CV event, the pursuers aver that
the increased risk of stroke or myocardial infarction is a material risk, in the sense of a more
than de minimis risk. It is averred that patients taking Celebrex who were not previously at
risk could become at risk by reason of their ingestion of the drug and that those already at
risk could become subject to an increased risk. It is averred that from 1999 onwards the
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defenders had evidence that Celebrex was implicated in a significant and materially
increased risk of serious cardiac side effects but that the dangers were not disclosed until
January 2005.
[31] In statement 6 of the condescendence in each of the Records the pursuers aver that
their injury was caused by fault and negligence on the part of the defenders. They aver that
their respective GPs reasonably relied on the defenders to disclose information of any
known risks, dangers or side effects of the drug and that the defenders knew or ought to
have known that they would so rely. They aver that the defenders knew or ought to have
known that Celebrex carried the risk of increased CV events for long-term users. The
defenders accordingly had a duty to bring such a risk to the attention of consumers and
medical practitioners whereas they did not do so until after the pursuers had stopped taking
the drug. The pursuers aver that had the defenders fulfilled the duties incumbent upon
them the pursuers’ GPs would not have prescribed Celebrex and the pursuers would not
have suffered loss and damage. Moreover, as it was not possible for GPs properly to advise
their patients of the risk of serious adverse CV events, the pursuers were prevented from
giving informed consent to a decision by the GP to prescribe Celebrex.
[32] Section 2 (1) of the Consumer Protection Act 1987 provides that where any damage is
caused wholly or partly by a defect in a product, the producer of the product, any person
who has held himself out to be the producer of the product, and the importer of the product,
shall be liable for the damage. Put shortly, in terms of section 3 of the Act there is a defect in
a product if the safety of the product is not such as persons generally are entitled to expect.
The pursuers aver that, as a pharmaceutical product marketed without information being
provided as to CV risk, Celebrex was defective.
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The Lord Ordinary’s decision
[33] The Lord Ordinary discusses the submissions that he had heard under the respective
heads of relevancy and specification. Looking first at the common law case his assessment is
that while the pleadings are lengthy and detailed, and might in places be viewed as straying
from giving notice of lines to pleading evidence, the essence of the common law case is
relatively simple. In the view of the Lord Ordinary the pursuers sufficiently identify the
medical events they found on as giving rise to their loss. They identify the duties said to
have been breached and how those breaches led to the pursuers taking Celebrex on
prescription. They aver that but for the ingestion of Celebrex, they would not have suffered
the loss, injury and damage for which they seek reparation. It is apparent from the
pleadings that each pursuer aims to prove that his consumption of Celebrex caused, in the
sense that it made a material contribution to, the medical event(s) on which he founds.
Accordingly, it cannot be concluded at this stage that should the pursuers establish all that
they seek to prove, still their case at common law must fail. The Lord Ordinary’s conclusion
is the same in relation to the case based on the Consumer Protection Act.
[34] The Lord Ordinary heard an argument premised on what was said by
Gauges Ltd v BEC (Scotland) Ltd 2001 GWD 3-126 on what was required when pleading a case
of fraud. Twenty one passages from the pursuers’ pleadings were identified by the
defenders as examples of instances where fraud (or at least deliberate wrongdoing) was
averred and subjected to the criticism that the pursuers do not given sufficient notice of who
was responsible for the act, omission or representation complained of; what it consisted of;
when it was done and in what circumstances. The Lord Ordinary was unimpressed by these
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criticisms except in one instance. With the excision of that one passage he accordingly
allowed parties, before answer, proof of their respective averments.
The Grounds of Appeal
[35] The defenders present three grounds of appeal (albeit in four paragraphs, the first of
which being a general statement to the effect that the Lord Ordinary erred by allowing proof
before answer). Renumbered and with numbers substituted for bullet points to indicate
subordinate paragraphs, the grounds of appeal may be stated as follows:
1. The Lord Ordinary has erred in holding that the case of alleged common law
negligence is relevant and sufficiently specific to merit enquiry at proof before
answer. In particular:
1.1 The case pled against the defenders at common law is that they breached a
duty to “bring any known defects, risks, dangers or side effects of the drug to the
attention of consumers and medical practitioners.” The pursuers do not aver
what are the specific “defects, risks, dangers or side effects” to which they refer.
While they make various averments about what various studies allegedly
showed about cardiovascular risks, these averments, in so far as sufficiently
specific, do not pass the test of relevancy, and otherwise do not give the
defenders fair notice of what the pursuers intend to prove by them.
1.2 An averred duty to warn of a risk which did not in fact eventuate is
what is the “risk” of which the pursuers contend notification should have been
given and an offer to prove that that particular risk materialized in the case of the
pursuers, the pursuers’ pleadings are irrelevant on that ground also.
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1.3 The pursuers do not aver by what means and in what terms the defenders
had a duty to “bring any known defects, risks, dangers or side effects of the drug
to the attention of consumers and medical practitioners.” In the absence of
averments about what should have been the terms of the alleged notification of
whatever alleged “defects, risks, dangers or side effects” the pursuers found on,
by what means the notification should have been made, and to whom
notification by that means should have been directed, the pursuers are not in a
position to lead evidence of a causal connection between any alleged injury
suffered by them and the duty averred.
2. The Lord Ordinary erred in holding that the case based on the provisions of the
Consumer Protection Act 1987 is relevant and sufficiently specific to merit enquiry at
proof before answer. In particular:
2.1 All medicines have side effects. Consumers of a pharmaceutical medicinal
product are not entitled to expect that such a product will be free from risk:
specify what is the defect upon which they found. They fail to specify in what
way Celebrex was not as safe as persons generally were entitled to expect. The
averment that “Persons consuming Celebrex, including the pursuer, were
entitled to expect that it would not carry the high risk of adverse cardiovascular
events, such as that which befell the pursuer and as herein condescended on”
does not give fair notice of what persons generally are entitled to expect.
“Persons generally” do not know the pursuers or what happened to them, and
the events which occurred to each pursuer were different from that which
occurred to the other. John Jarvie avers he experienced two strokes. Ronald
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Richards avers that he suffered a heart attack. John Jarvie does not offer to prove
that Celebrex causes strokes, nor (if that is his case) does he offer to prove at what
dosage Celebrex causes strokes. Ronald Richards does not offer to prove that
Celebrex causes heart attacks, nor (if that is his case) does he offer to prove at
what dosage Celebrex causes heart attacks. The reference to “the high risk of
adverse cardiovascular events such as .... hereinbefore condescended on” is
irrelevant and lacking in specification for the same reasons as the common law
case is irrelevant and lacking in specification. The pursuers are not in a position
standing their pleadings to lead evidence of a defect in Celebrex.
2.2 In circumstances where John Jarvie does not offer to prove that Celebrex
causes strokes, and in particular does not offer to prove that it causes strokes at
the dosage at which it was prescribed for him, his averments are not habile to
instruct a case that the alleged injury which occurred to him was caused by a
defect in Celebrex. In circumstances where Ronald Richards does not offer to
prove that Celebrex causes heart attacks and in particular does not offer to prove
that it causes heart attacks at the dosage at which it was prescribed for him, his
averments are not habile to instruct a case that the alleged injury which occurred
to him was caused by a defect in Celebrex. The pursuers aver in article 7 of
condescendence that: “Had the warnings been provided from the outset, few if
any doctors in the UK would have prescribed the medication.” However on the
pursuers’ pleadings the defect under the 1987 Act upon which they found is not
the absence of warning. Thus the pursuers aver “Not only was the product
defective, the defenders knew it to be so. If it was not defective, they would not
have required to alter the warnings on the packaging to a material effect as they
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did.” Accordingly, whatever alleged (unspecified) defect in Celebrex the
pursuers found on they cannot establish that even if it existed and was a “defect”
within the meaning of the 1987 Act it caused their loss.
2.3 If (contrary to their averments in the first part of article 7 of condescendence)
the alleged defect on which the pursuers rely is some alleged deficiency in
warning, the pursuers’ case under the 1987 Act is not relevantly pled as a case
where the alleged defect in Celebrex founded on was a deficiency in warning.
Further the pleadings do not give notice of what was the alleged deficiency in
warning, if any, upon which the pursuers found. Such specification is necessary
to determine whether any such alleged deficiency of warning constitutes a defect
within the meaning of the Act; and is central also to the question of whether or
In the absence of such specification the pursuers are not in a position to prove to
whom the warning(s) should have been directed nor what the terms of such
warnings should have been nor what the effect thereof would have been, if any,
on the prevention or otherwise of the strokes and heart attack suffered by John
Jarvie and Ronald Richards respectively.
3. The Lord Ordinary has erred in holding that the pursuers’ averments anent fraud
and deceit on the part of the defenders provide the defenders with fair notice of the
case made against them and that they are sufficiently specific and relevant as to merit
enquiry. Esto said averments are sufficiently specific per se (which is denied), on the
basis of concessions at the Bar by Senior Counsel for the pursuers that fraud is
incidental to the issue before the court, they are, in any event, extraneous and
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irrelevant to both of the grounds of action in these litigations. They should therefore
Submissions
Defenders
[36] On behalf of the defenders, Ms Shand QC adopted her revised note of argument.
She pointed to the pursuers’ averments that they had each been prescribed Celebrex at the
United Kingdom approved dosage of 200mg per day. However, despite a variety of
formulations adopted in their averments about increased risk under reference to a number
of studies, the pursuers did not aver that there was a statistically significant increased risk of
adverse CV events at that dosage. The studies referred to included those which involved
dosages of up to 800mg per day. An averment quantifying the increase in risk was
important for a determination of whether or not there was a duty to provide a warning, the
terms of such a warning, to whom it should be given and whether or not a supposed breach
of that duty actually caused the loss claim, it being for the pursuers to aver that the adverse
CV events which they suffered had indeed been caused by the ingestion of Celebrex at the
United Kingdom approved therapeutic dose. The essence of the defenders’ argument before
the Lord Ordinary was that the pursuers had not pled a relevant case of negligence based on
a supposed duty to warn. The Lord Ordinary had not properly analysed that argument. He
had failed to recognise that the viability of the propositions which he saw as encapsulating
the essence of the pursuers’ cases depended on the underlying detail of: (i) what level of risk
was known to or ought to have been known to the defenders; (ii) what was the specific risk
about which the defenders were under a duty to warn and in what terms such a warning
ought to have been given; and (iii) what would have happened relative to the occurrence of
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CV events suffered by the pursuers if such a warning had been given. The pursuers had not
provided the necessary specification by reference to what factor they alleged the risk to be
increased. They had accepted (at statement 2.3) that the relevant SPC did advise that among
the very rare side effects of Celebrex was a “less than 1 in 10,000 risk of heart failure and
myocardial infarction”. The pursuers do not aver what different warning should have been
given. They had failed to give fair notice of their case: cf Argyll & Clyde Health Board v
Strathclyde Regional Council 1988 SLT 381 at 383. It was no answer to say, as the Lord
Ordinary records had been said at the Procedure Roll debate, that expert witnesses would be
able at proof to explain the inferences to be drawn from the studies. If there are inferences
which will be relied on, they should be averred.
[37] As with the common law case, when addressing the statutory case under the
Consumer Protection Act 1987, the Lord Ordinary had failed properly to analyse the
detailed criticisms of the pursuers’ averments as to “increased risk” or “high risk”, which
was the foundation of the statutory case. No medical product is 100 per cent safe and
accordingly the pursuers cannot expect 100 per cent safety: Wilkes v Depuy International
Limited [2018] 2 WLR 531 at paras [13], [14] and [65]. The defenders were entitled to know
why the pursuers said that Celebrex was defective. It was not clear whether their case
related exclusively to lack of appropriate warnings or whether the complaint was that there
was something intrinsically wrong with the drug. If it were the latter what was said to be
wrong is not specified; if it were the former the required warning, absence of which made
the drug defective, is not specified. If, as appeared to be the case, the pursuers did not know
in what terms a warning should have been given, they are not in a position to establish that
had a warning been given the drug would not have been prescribed and therefore that the
pursuers would not have taken it. The context was that while regulatory approval (which
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had been given here) is not an automatic defence it is nevertheless powerful evidence that
the level of safety which people generally were entitled to expect had been achieved.
Moreover, there was no offer to prove the level of risk associated with the alternative
treatment which the pursuers would have undertaken had they not been prescribed
Celebrex.
[38] In any event, the pursuers’ numerous averments of fraud and deceit are irrelevant
and should be excluded from probation and that for two reasons. First, it was conceded on
behalf of the pursuers before the Lord Ordinary that fraud was incidental and extraneous to
the issue before the court and not an essential fact which had to be established. Second,
even if potentially relevant the averments in question were not sufficiently specific to give
the defenders the requisite high degree of notice which is appropriate with an allegation of
fraud.
Pursuers
[39] The motion made by Mr Smith QC on behalf of the pursuers and respondents was to
refuse the reclaiming motion and to adhere to the interlocutor of the Lord Ordinary,
appointing the cause to a diet of proof before answer. Properly analysed, the criticisms
made of the pursuers’ pleadings fell into four categories: (i) statistics; (ii) warnings; (iii)
causation; and (iv) fraud. Mr Smith explained that he would address each of these but, by
way of giving context, he began by drawing the court’s attention to the importance for the
system of statutory regulation which is to be attached to the content of SPCs and PILs:
cf Powers & Barton, Clinical Negligence (5th edit) para 13.17.
[40] Much of what the defenders had complained of was not a lack of essential
specification, rather it related to a level of forensic detail which is misplaced at debate. The
plea of lack of specification finds its proper application in a case where a defender does not
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know the case to be made against him and objects to being taken by surprise at the proof:
Macdonald v Glasgow Western Hospitals 1954 SC, per LP Cooper at 465; JD v Lothian Health
Board [2017] CSIH 27, per Lord Glennie at [72]. Criticism on lack of specification should be
proportionate. That advanced by the defenders was not. The defenders had been given fair
notice. The Lord Ordinary’s analysis at para [42] of his opinion was correct. The pursuers’
pleadings met the test of relevancy: Jamieson v Jamieson 1952 SC (HL) 44.
[41] Turning to the part of his submissions which Mr Smith headed “statistics”, he
pointed to the pursuers’ averments about drug trials demonstrating an increased risk of
adverse CV events at therapeutic levels (upwards of 100 mg per day). Indeed there is an
averment that in studies conducted by the defenders on patients with arthritis the estimated
rate (of onset of a CV event) ratio exceeded 2 at a dose of 100mg and exceeded 3 at a dose of
400mg, but in any event it could not be said that the results of trials at higher levels were
irrelevant to demonstrating the probability of adverse events. Unless otherwise indicated,
increase in risk meant increase over a placebo or no administration at all. Contrary to the
defenders’ submission it was not necessary for the pursuers to aver the actual level of
enhanced risk to which they as individuals were exposed; that is a medical and scientific
impossibility. It was sufficient that they averred, as they did, that the increased level of risk
was a material risk. This was consistent with the issue in 2005 by the EMEA of urgent safety
restrictions for COX-2 inhibitors on having obtained further data from the defenders. It was
not the function of the court to determine an absolute level of risk to which the pursuers
were exposed. The judge is not required to search for medical certainty: Elvicta Wood v
Huxley [2000] WL 664536, 19 April 2000. To use the language of Mackay J in XYZ v Schering
[2002] EWHC 1420, the place of the court was not in the forest of epidemiology but in the
open country where the simpler concept of balance of probabilities rules.
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[42] On warnings, it was the pursuers’ case, as they had averred, that the defenders ought
to have included a warning on the SPC provided to the regulatory authorities and all later
approved versions of the SPC, whereas no proper warnings were provided. Again as
averred, it was the public, and particularly prescribing doctors and their patients, who
should be warned. The content of the warning should have reflected the results of the
studies which were available to the defenders. What appeared on the “black box” warning
which the defenders agreed on 7 April 2005 with the United States Food and Drug
Administration to include in the Celebrex label would have provided a good model, but the
pursuers’ case was that what was required were words to the effect that consumption of
Celebrex involves a significant increase in CV risk. No such warning was given by the
defenders prior to the pursuers suffering their respective adverse CV events.
[43] As to causation, Mr Smith confirmed that, as they had pled, the pursuers intended to
prove that their respective GPs would not have prescribed Celebrex had a warning of the
material risk of adverse CV events been given, indeed if that warning had been given from
the outset they say that few if any doctors in the United Kingdom would have prescribed it.
In the result patients were prevented from giving informed consent. The pursuers further
intended to prove that had they not taken Celebrex they would not suffered adverse CV
events. The evidence for that would be a combination of medical evidence as to mechanism
and statistical evidence as to likelihood of an adverse CV event given the increased risk
associated with Celebrex. The Lord Ordinary had correctly understood the pursuers’ cases
as appeared from paragraph [43] of his opinion.
[44] Turning finally to the averments of fraudulent conduct on the part of the defenders
which are discussed by the Lord Ordinary at paragraphs [57] to [84] in his opinion,
Mr Smith confirmed that he was not making a case of fraud as such; he had no plea which
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would support such a case. That did not mean that they were irrelevant. The
Lord Ordinary, before whom the defenders had attacked these averments as lacking in
specification, had been correct to admit all but one sentence of them to probation. It was the
pursuers’ case that the defenders knew their product was defective in the sense of carrying a
material risk of adverse CV events when taken in therapeutic doses. That the defenders did
not disclose that fact and were accordingly responsible for suppressio veri or suggestio falsi
was a legitimate line of evidence. It was plainly relevant to proving that a product is
defective for evidence to be led that the defenders knowingly omitted data or information
concerning the safety of the product when seeking marketing authorisation in the United
States or Europe. A “defect” exists if the safety of the product is not such as persons
generally are entitled to expect: 1987 Act, section 3(1). If the manufacturer of a medicine
deliberately omits any warning of CV risk which they know of from the SPC, then prima facie
the safety of the product is not as the consumer is entitled to expect from a consideration of
the terms of the SPC.
Discussion and decision
[45] The Lord Ordinary took the view that, as pled, these were relatively simple cases,
albeit encumbered with unnecessarily lengthy and detailed averments. He gave short shrift
to the defenders’ arguments to the effect that the respective cases were irrelevant because of
a fundamental lack of specification. We agree with the Lord Ordinary’s assessment and we
propose to follow his approach when it comes to disposal. Proof of a simple case may of
course turn out to be very complicated, but proof is not what we are concerned with at this
stage.
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[46] The Lord Ordinary described the pursuers’ averments as straying from giving notice
to pleading evidence. That is an understatement. Other criticisms might be advanced of the
pursuers’ condescendence, particularly statement 2. However, for present purposes all that
need be considered are the defender’s complaints of lack of specification, in other words the
contention that the pursuers have failed to frame their cases with sufficient clarity and
precision to allow the defenders know what they have to respond to.
[47] Despite Ms Shand’s protests to the contrary, we do not accept that the defenders can
legitimately say that they do not have notice of the case against them. When what is in
issue is specification, as is self-evident, what is required will depend on the nature of the
case but regard must also be had to the identity of whom the pleadings are primarily
addressed: the other party; and what the other party is already aware of and what the
other party may be taken readily to understand. We were referred to Macdonald v Glasgow
Western Hospitals and Hayward v Edinburgh Royal Infirmary 1954 SC 453. These were actions
against the boards of management of then fairly recently nationalised hospitals, founding
on the alleged negligence of members of the resident medical staff. In Macdonald it was a
house surgeon who was blamed. The board pleaded that they were not vicarious liable for
his fault (then an arguable proposition). One of the points taken was that the pursuer’s
averments were lacking in specification in respect that full particulars were not given as to
the precise terms of the surgeon’s contract and the extent of the Board’s control over him.
Lord President Cooper said this at 465:
“This objection seems to me to come with an ill grace from a state authority to the
representatives of a patient under the state scheme. The plea of lack of specification
finds its proper application in a case where a defender does not know the case to be
made against him and objects to being taken by surprise at the proof. In this instance
the Board and their house surgeon know perfectly well what their contract was and
how it operated, and the pursuer cannot know these things except by obtaining
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information from the defenders. I am unimpressed by this objection and am
surprised that it was taken.”
[48] We do not suppose that the defenders in the present case are necessarily as
disingenuous as were the Board of Management of Glasgow Western Hospitals, but in
considering Ms Shand’s submissions that the defenders have not been given fair notice of
the case against them, the identity of the defenders and the nature of the activity with which
the actions are concerned, provides the context in which her submissions have to be
considered. In the actions before us the defenders are the representatives of the various
entities responsible for bringing Celebrex to the market, first in the United States and then in
the United Kingdom and the rest of the EU. They are the market authorisation holders in
the United Kingdom. They are familiar with the regulatory process and the way in which
medicinal products are marketed. Subject to the control of the licensing authority, they are
responsible for framing the terms of the relevant SPC and PIL. They may be taken to know
all that is known about Celebrex and its effects.
[49] What we have designated as ground of appeal 1 is directed at the sufficiency of
specification and therefore the relevancy of the pursuers’ common law case whereas what
we have designated as ground of appeal 2 is directed at the sufficiency of specification and
therefore the relevancy of the pursuers’ case based on the Consumer Protection Act 1987.
While there is overlap as between the two grounds, ground 1 focuses on inadequate
specification of “risk” whereas ground 2 focuses on inadequate specification of “defect”. It
is convenient to look at “defect” first.
[50] In ground 2.2 the defenders contend that there is, at best, ambiguity as to the defect
of which the pursuers are complaining. We see no such ambiguity, although it would have
to be conceded that the matter is put more clearly in Mr Jarvie’s pleadings than those of
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Mr Richards’s. As we have already observed, in terms of section 3 of the Consumer
Protection Act there is a defect in a product if the safety of the product is not such as persons
generally are entitled to expect. In each of the actions the pursuers aver that, as a
pharmaceutical product, Celebrex was defective and that not only was it defective but that
the defenders knew that to be so. In each of the actions the pursuers go on to make
averments about alterations to the warnings on the packaging for Celebrex and in the PIL,
concluding that a warning should have been applied from the outset. We would therefore
see it as reasonably clear from the Record in either of the actions what it is the pursuers are
complaining about, but the point is quite specifically addressed in the pleadings in Mr
Jarvie’s action to which reference was made in the hearing before us. There, at statement 7
(page 64D) it is stated (emphasis added):
“Persons consuming Celebrex, including the pursuer, were entitled to expect that it
would not carry the high risk of adverse cardiovascular events, such as that which
befell the pursuer as hereinafter condescended upon. The pursuer was entitled to
expect that Celebrex would not cause or materially contribute to the cardiovascular
event suffered [by the pursuer] without a clear warning being given to that effect.”
[51] Thus, and this was confirmed as the being the position by Mr Smith, the pursuers do
not say that there is anything intrinsically defective about Celebrex. What makes it a
product that has a defect is that it was marketed without a warning as to the risk of adverse
CV events associated with its long-term consumption.
[52] Staying with “defect” but also beginning to address what the grounds of appeal have
to say about “risk”, at ground of appeal 2.1 the defenders aver that consumers of a medicinal
product are not entitled to expect that such a product will be free from risk. They refer to
Wilkes v Depuy International Ltd where, at para 13 of his judgment, Hickenbottom J observed
that no medicinal product is free from risk, in the sense of the hazard or chance of the
happening of a particular adverse event that will cause loss or damage. That may be so.
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However, under the regulatory regime described above, no medical product is marketed
without information being given in writing about any relevant risks of adverse effects
consequent on the use of the product. The media through which such information is given
include SPCs and PILs. Thus, the defenders may be correct when they say that consumers
are not entitled to expect that a medicinal product will be free from all risk but, on the other
hand, consumers are entitled to expect that where there is a relevant risk which is known
about, then it will be the subject of a warning. That proposition is the basis of both the
pursuers’ common law and statutory cases and we see it to be clearly spelled out in their
pleadings. To the extent that ground of appeal 2 depends on a supposed failure to specify
what is the “defect” which is founded upon, it must be rejected.
[53] At ground 2.3 the defenders complain that, if it is the pursuers’ case that the defect in
Celebrex was a deficiency in warning, then the pleadings do not give notice of what that
deficiency in warning was. This echoes the complaint at ground 1.3 that the pursuers do not
aver by what means and in what terms the defenders had a duty to “bring any known
defects, risks, dangers or side effects of the drug to the attention of consumers and medical
practitioners.”
[54] “Deficiency in warning” is the defenders’ expression. We are not aware of it
occurring anywhere in the pursuers’ pleadings. What the pursuers found on, and in our
opinion this is critical to the assessment of the relevancy of their pleadings, is the complete
absence of any warning to the licensing authority, to medical practitioners, or to patients of
the increased CV risks associated with Celebrex and known about by the defenders. That
this is the pursuers’ position appears at statement 2.3:
“The SPC proposed by the defenders [to the Swedish Medical Products Agency]
made no reference to increased risk of adverse serious cardiovascular events caused
by Celebrex. After marketing authorisation was granted in the UK, the SPC for
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Celebrex 100 mg and 200 mg capsules did not warn of cardiovascular risks
associated with the drug. Under the heading ‘Undesirable Effects’, very rare side
effects include ‘Cardiovascular: heart failure, myocardial infarction’. These were
said to be less than 1 in 10,000 patients, or in isolated reports. ...Celebrex first
appeared in the British National Formulary ...in September 2000 ...There was no
specific warning about cardiovascular risk.”
What the pursuers aver the defenders did not do but should have done appears later in
statement 2.3:
“The defenders ought to have included a warning in the proposed SPC and all later
approved versions of the SPC that Celebrex increased the risk of patients suffering
serious adverse cardiovascular events.”
At statement 2.5 there is this:
“... no proper warnings were provided that communicated the information on risks
that the defenders were in fact aware of. At no time did the warning labels or patient
information leaflets disclose the truth, viz that there was a significantly increased CV
risk to patients.”
The only duty on which the pursuers rely in respect of their negligence case is as follows
(statement 6):
“The defenders had a duty to bring any known, defects, risks, dangers or side effects
of the drug to the attention of consumers and medical practitioners prescribing the
drug that there was a risk of increased myocardial infarction associated with the long
term use of Celebrex”
There follows the averment of breach:
“They did not do so until after the pursuers had ceased taking the medication.”
Causation is addressed in the following sentence:
“Had the defenders fulfilled the duties incumbent upon them, the pursuer’s GP
would not have prescribed Celebrex and the pursuer would not have suffered the
loss, injury and damage as hereinafter condescended.”
[55] As we would see as being quite clear from the pursuers’ averments, their case
against the defenders is that of an absolute failure to give information about a relevant
matter of which the defenders were aware. That is so both in respect of their case of
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common law negligence and in respect of their statutory case. Once that is appreciated, any
basis that there might otherwise be for grounds of appeal 1.3 and 2.3 falls away. It is enough
that the pursuers aver that a warning about a relevant risk which should have been given
was not given. As Mr Smith was able to illustrate, there are a number of averments to that
effect.
[56] Given that the pursuers’ case is that of an absence of warning in the context of a
regulatory scheme with which the defenders must be taken to be very familiar, we were
particularly unimpressed by the complaints that appear in ground of appeal 1.3 that the
pursuers had failed to specify by what means, notification of warnings should have been
made, and to whom notification by that means should have been directed. As we have
explained above, the SPC is one of the ways in which an applicant for marketing
authorisation communicates with the licensing authority and that document, once
approved, will be a source of information for the medical profession either directly or
indirectly, as will the PIL, which is also available to the individual patient for whom the
drug is prescribed. The pursuers specifically aver that the SPC for Celebrex made no
reference to the increased risk of CV events caused by the drug. “Prescribing doctors and
patients”, “GPs, or to patients directly”, “the public or GPs” and “the public and GPs” are all
identified in the pleadings as those to whom information about the relevant risk should
have been communicated.
[57] In this latter part of our opinion we have referred to the risk which, according to the
pursuers, gives rise to a duty to warn medical practitioners and their patients, as the
“relevant risk”. That formulation avoids identifying just what it is that we are talking about.
Grounds of Appeal 1.1 and 1.2 present a similar criticism of the pursuers’ pleadings.
Ms Shand argued that, for all the various formulations which were to be found in the
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33
pursuers’ averments, they nowhere identify just what the “risk” associated with Celebrex
was. She submitted that it was for the pursuers to identify and with a degree of precision to
quantify, the risk of which they said the defenders were aware. This was important in
determining what duties such a risk gave rise to. It was also important for the purpose of
establishing causation both at the stage of determining what the pursuers and their medical
advisers would have done if informed of the particular risk, and at the stage of determining
whether the risk which eventuated when the pursuers suffered their respective CV events
was the same risk as that of which they should have allegedly been warned (a risk which
does not eventuate being irrelevant). This, Ms Shand submitted, was not achieved by
references to a number of studies and trials some of which had involved taking Celebrex at
dosages in excess of that authorised for therapeutic use in the United Kingdom.
[58] For the purpose of these actions the pursuers define what they mean by the relevant
risk at statement 2.6 of condescendence where it is averred:
“Selective blocking of the COX-2 enzyme interferes with the production and
operation of prostacyclin, rendering the formation of blood clots more likely.
Prostacyclin acts chiefly to prevent platelet formation and the clumping that is
involved in clotting. Increased risk of clots causes an increased risk of stroke or
[myocardial infarction]. Patients not at risk previously could become at risk; and
those already at risk had an increased risk of an adverse effect. The increase of risk is
a material risk, being more than de minimis.”
In the same statement the pursuers go on to aver that the defenders were aware of this
particular risk prior to Celebrex being granted market authorisation in the United Kingdom
but that they did not communicate that information to the licensing authority:
“As is otherwise averred, as from 1999 onwards, the defenders had evidence that
Celebrex was implicated in significant and materially increased risk of serious
cardiac side effects. The dangers were not disclosed until January 2005.”
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[59] In our opinion these averments are sufficient for the purpose of the pursuers’ case.
We return to the point made above. The pursuers allege that the defenders provided simply
no information about the increased risk of clot formation and the consequent increased risk
of stroke and myocardial infarction associated with the use of Celebrex, either to the
licensing authority or to patients and doctors. They allege that the defenders knew about
the risk but chose not to disclose it. The pursuers go on to allege that they were prescribed
Celebrex and as a result suffered strokes and a myocardial infarction respectively, events
which they say were within the scope of the risk (cf BPE Solicitors v Hughes-Holland
[2017] 2 WLR 1029), whereas had they and their medical advisers known of the risk they would not
have agreed to prescribe or take the drug. That, as the Lord Ordinary observed, is a
relatively simple case. For the purposes of such a case it is sufficient to aver that the
deliberately undisclosed risk was “a material risk, being more than de minimis.”
[60] We would accept that identifying a risk as a “material” risk involves some
circularity; a risk is material because it is a risk that should not be ignored. Moreover,
proving that a risk is material may become a quite complicated evidential and evaluative
exercise. At para 14 of Wilkes Hickenbottom J quotes para 13.29 of Powers & Barton. There
the authors say this:
“Determining the safety of a product is a holistic approach that calls for an integrated
assessment of the clinical and laboratory adverse effects associated with the product
in terms of their frequency, seriousness, severity, reversibility and outcome, and
determining whether the risk can be mitigated by warnings on any risk factors. That
assessment is complex and takes into account a range of factors including the nature
of the disease or condition to be treated, the type of patient and the duration of
treatment. It is important to appreciate that regulators approve or disapprove a drug
on the basis of risk/benefit at a population level and not at an individual patient
level.”
However these complexities are matters for proof. The pursuers have committed
themselves to the position that the increased risk of an adverse CV event was material, just
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as they have committed themselves to the position that no warning of that was given despite
it being known to the defenders. The Lord Ordinary was correct to allow the pursuers to
attempt to prove that. The various references to studies and trials provide hints as to how
they will go about that but, given the nature of the pursuers’ case, to require them to go
further by way of averment would be to require them to plead evidence (more accurately,
more evidence) and argument.
[61] The submissions in relation to grounds 1 and 2 raised a number of incidental points.
Ms Shand argued that reference to studies where subjects had been taking in excess of the
United Kingdom authorised dose was irrelevant. We disagree. What is to be made of such
studies is a matter for determination at proof; the pursuers also make reference to studies
where subjects were taking the United Kingdom therapeutic dose. Ms Shand criticised the
failure to aver the particular level of risk to which the individual pursuers were exposed.
Mr Smith’s response was that it is not medically or scientifically possible to define the
statistical risk of CV events to all patients from the ingestion of Celebrex on the basis of a
single study in terms of a single figure. We suspect that that may be correct, but again it is a
matter for proof as to the extent to which it is legitimate to ascribe the experience of a
population to the experience of an individual. Ms Shand also submitted that the pursuers
do not aver what would have happened if the desiderated warning had been given. As we
have perhaps already indicated, we do not accept that. The pursuers’ case is that their
general practitioners would not have prescribed Celebrex for them. That seems to us clear
from the pursuers’ averments; that is what they offer to prove.
[62] We accordingly reject grounds of appeal 1 and 2 in their entirety.
[63] Ground of appeal 3 is directed at the averments alleging fraud and deceit on the part
of the defenders in failing to disclose information as to the association between the ingestion
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of Celebrex and adverse CV events. Ms Shand submitted that these averments were
insufficiently specific but if that submission was not accepted they were in any event
irrelevant.
[64] We do not question the correctness of Lord Macfadyen’s statements of the law in
Royal Bank of Scotland v Holmes and Buchanan (Stewart) Gauges Ltd v BEC (Scotland) Ltd but in
so far as they are applicable in the circumstances of the present cases, we consider that they
were correctly applied by the Lord Ordinary when he allowed proof of all but one of the
passages in the pursuers’ averments which the defenders had criticised as not meeting the
rigorous standards for a case of fraud. We say “in so far as they are applicable”, because the
pursuers’ cases do not depend on establishing the delict of fraud as such. What is critical in
any case, as the Lord Ordinary appreciated, is that a party is given fair notice of his
opponent’s position and in assessing that the strictures of Lord President Cooper in
Macdonald apply. Lord Macfadyen addressed that in Buchanan in a passage quoted by the
Lord Ordinary in his opinion in the present case:
“The party against whom any allegation is made is entitled to have fair notice in the
other party's pleadings of the substance of the allegation. Where the allegation is of
fraud, the courts have applied that rule of fairness particularly strictly. But, in my
view, even in a case of fraud, a defender is not entitled to complain of lack of
specification if the pursuer's pleadings give him what in the circumstances amounts
to fair notice of the allegation. He cannot, through reliance on the authorities about
the high standard of specification required in cases of fraud, demand that the
pursuer's averments go into more detail than is necessary to give fair notice of the
case.”
[65] We see the Lord Ordinary as having considered each of the criticised passages of
averments from the perspective identified by Lord Macfadyen in Buchanan as being
appropriate. In all but one instance the Lord Ordinary held the averments to be sufficiently
specific. We agree with that assessment for the reasons given.
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[66] The defenders submit that these averments are in any event irrelevant. We disagree.
The pursuers’ case is that the CV risks associated with Celebrex were known to the
defenders and that as applicants for marketing authorisation and then suppliers of the
product to the public they were under a duty to disclose that information. In the absence of
a warning of these risks it is contended that Celebrex is a product with a defect for the
purposes of the Consumer Protection Act. It may not be necessary for the pursuers to
succeed in that case that they prove fraud on the part of the defenders, but it cannot be said
to be irrelevant to their case, namely that the defenders knowingly omitted data or
information concerning the safety of the product when seeking marketing authorisation in
the United States or Europe and in their subsequent interactions (or absence of interactions)
with the regulatory authorities or that they made false claims as to the safety of Celebrex or
that they selectively released data or that they otherwise kept information from the public.
Evidence that the defenders deliberately chose not to disclose information and the available
inference that this was done so as not to impact adversely on the marketability of the
product, would clearly be relevant to inform the question as to what persons generally are
entitled to expect for the purpose of section 3 of the 1987 Act and to displace any suggestion
of there being a defence in terms of section 4 (1) (e) that the state of knowledge was not such
that a producer of such products might be able to discover the defects. Moreover, if, as Ms
Shand argued, regulatory approval is powerful evidence that the level of safety which
people were entitled to expect had been achieved, evidence that approval had been given as
a result of fraud would be relevant to displace the significance of the regulatory authority
having given marketing authorisation.
[67] We accordingly reject ground 3.
[68] We shall refuse each of the reclaiming motions. We reserve all questions of expenses.
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Postscript
[69] As the Lord Ordinary decided, these actions can now proceed to proof. It is not
however too late for more active case management than has apparently proved possible so
far. We have insufficient information to determine the reasons for this but on the face of it
only limited progress has been made despite these actions being raised some eight years
ago. There may be difficulties of which we are not aware, but if that is so then parties and
the court should set about addressing them.
Appendix
Acronym Full name
CHM
CHMP
COX-1
COX-2
CPMP
CSM
CV
EMA
EMEA
FDA
MCA
MHRA
NSAID
PIL
Commission on Human Medicines
Committee for Medicinal Products for Human Use
cyclo-oxygenase 1
cyclo-oxygenase 2
Committee for Proprietary Medicinal Products
Committee on Safety of Medicines
Cardiovascular
European Medicines Agency
European Agency for the Evaluation of Medicinal Products
United States Food and Drug Administration
Medicines Control Agency
Medicines and Healthcare Products Regulatory Agency
Non-steroidal Anti-inflammatory Drug
Patient Information Leaflet
Page 39 ⇓
SPC or
SmPC
39
Summary of Product Characteristics