(FIRST) RONALD RICHARDS; AND (SECOND) JOHN JARVIE AGAINST PHARMACIA LIMITED C/O PFIZER LIMITED
OUTER HOUSE, COURT OF SESSION
[2017] CSOH 77
(1) A256/10 & (2) A273/10
OPINION OF LORD BECKETT
In the cause
(FIRST) RONALD RICHARDS; and (SECOND) JOHN JARVIE
Pursuers
against
PHARMACIA LIMITED, c/o Pfizer Limited
Defenders
Pursuer: Smith QC, Murray; Lefevre Litigation
Defender: Anderson QC, Middleton; DWF LLP
12 May 2017
Introduction
[1] These actions are but two of more than sixty actions before this 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 brand name Celebrex. Such claims are subject to Practice Direction No 2 of 2010, “Personal Injury Actions relating to the drugs Vioxx and Celebrex.” In these two cases the pursuers aver that they each suffered a serious cardiovascular (CV) event as a result of ingesting Celebrex on prescription. Both pursuers found on fault at common law and separately aver that Celebrex was a defective product giving rise to liability under the Consumer Protection Act 1987, section 2, for damage caused.
[2] I heard a Procedure Roll Debate arising from the defenders’ challenge to the relevancy and specification of the pursuers’ pleadings. The defenders seek dismissal, failing which a proof before answer and exclusion from probation of certain averments. The pursuers did not insist on their preliminary pleas and propose that a proof before answer be appointed.
[3] Whilst the designation of the defenders is as stated above, it is accepted on all sides that the defenders are the corporate successors of certain companies in the UK who participated in the research, development and UK marketing of the drug Celebrex, and the defenders take no issue with the pursuers’ interchangeable use of the term “defenders” to describe interrelated companies including Pfizer Inc, Pfizer UK and Pharmacia Ltd.
[4] Mr Anderson QC and Mr Middleton, advocate appeared for the defenders and Mr Smith QC and Mr Murray, advocate appeared for the two pursuers in what was in effect one debate given that precisely the same issues arose in relation to pleadings which, subject to the individual circumstances of each pursuer, are almost identical. A revised version of the record was lodged at the bar at the outset of the debate; No 49 of process in the case of Mr Richards and No 59 of process for Mr Jarvie.
The Pleadings
[5] The pursuers’ averments are long and detailed as are the defenders’ answers in a record extending to 73 pages in the case of Mr Richards and 71 for Mr Jarvie.
[6] It is not disputed that traditional NSAIDS such as ibuprofen and aspirin can have gastrointestinal side effects. In the 1990s the defenders developed a method of producing a painkiller without such side effects and created the drug Celebrex. A rival company, Merck Inc., produced Vioxx, a similar product. The generic term for these drugs is “COX‑2 inhibitors.”
[7] The pursuers aver that there was commercial pressure on the defenders to get their product first to market.
[8] The pursuers aver that the defenders applied to the United States Food and Drug Administration (FDA) for approval to market Celebrex in the US for treatment of the symptoms of arthritis and osteoarthritis and that they contended in their application that Celebrex was more effective and safer than other currently available NSAIDs founding on studies listed in Article 2.3 of condescendence (Condescendence 2.3). Celebrex was approved by the FDA in December 1998 and Vioxx in May 1999. Celebrex 100mg and 200mg capsules received marketing authorisation in the United Kingdom in May 2000 which had first been granted in Europe by the Swedish regulatory authority. The application to Sweden included a proposed summary of product characteristics (SPC) for agreement with the European Medicines Agency (EMEA) which made no reference to increased risk of adverse serious CV events caused by Celebrex which was also the position when approval was granted in the UK. The SPC forms the basis for the patient information leaflet (PIL) which accompanies the product on sale. The pursuers aver that the SPC listed under a heading “Undesirable Effects” that very rare side effects include “cardiovascular: heart failure, myocardial infarction,” said to occur in less than 1 in 10, 000 patients or in isolated reports.
[9] The pursuers aver that in October 2004, the EMEA alerted users and prescribers of COX‑2 inhibitors to a warning for patients with a history of cardiovascular disease. In December 2004 the defenders informed EMEA of the results of a trial of Celebrex to prevent adenoma involving 2400 patients with an average duration of 33 months’ treatment taking either 400 or 800mg doses daily indicating increases in rates of occurrence of CV events: 2.5 fold and 3.4 fold at the respective doses of 400 and 800mg. It was found that 26 patients taking a dose greater than 100mg were known to have suffered serious CV events compared with five taking placebo. In the defenders’ “PreSAP” trial, 13 patients on Celebrex experienced serious CV events compared with five on placebo. The defenders were invited to appear before EMEA’s Committee for Medicinal Products for Human Use to discuss the efficacy and safety of Celebrex. In February 2005, the EMEA issued urgent safety restrictions for COX‑2 inhibitors to the effect that they are contraindicated in patients with ischaemic heart disease or stroke. Prescribers were warned to exercise caution when prescribing COX‑2 inhibitors for patients with risk factors including heart disease, hypertension, hyperlipidaemia and peripheral arterial disease and to use the lowest effective dose for the shortest possible time. In 2000 and 2002 there were no specific warnings about Celebrex in the British National Formulary, but by 2005 there were pointed warnings about concerns relating to the safety of COX‑2 inhibitors, particularly for patients with ischaemic heart disease and cerebrovascular disease. Medical practitioners are guided by the British National Formulary and the SPCs on which it is based.
[10] The pursuers aver that the defenders omitted to provide data from the Celecoxib Long Term Arthritis Safety Study (CLASS) study to EMEA when it became available and that they omitted to include other data indicating a statistically significantly increased risk of CV events. They aver that the defenders ought to have included in the proposed SPC a warning that Celebrex increased the risk of patients suffering serious adverse CV events such as myocardial infarction, stroke or sudden cardiac death.
[11] They aver that Pfizer Inc was engaged to launch the product along with Searle and that the defenders acquired the rights to Celebrex in December 1999.
[12] The pursuers aver:
“It was maintained by the defenders that Celebrex was safer than Vioxx in respect of CV safety, despite their knowing from their own and other studies that there were significant CV risks. As is hereinafter averred, as a pharmaceutical product, Celebrex was defective; and the defects in its function were known to the defenders but concealed from the public and those who were responsible for sanctioning it release on to the market.”
[13] In Condescendence 2.4 the pursuers aver bases on which the defenders would have known of potential adverse CV events associated with the use of COX‑2 inhibitors from 1997 onwards, and more clearly from 1999 onwards. Specified studies undertaken by the defenders in connection with arthritis are said to have shown that there was an increased risk of CV events for patients taking doses of 100mg or more as compared with a placebo. In response to a requirement of the FDA, the defenders commissioned the CLASS study.
[14] It is averred that the defenders were aware of “the significant risks to patients taking Celebrex” and the averments in Condescendence 2.4 specify that their knowledge was derived from studies they commissioned and the results of which the defenders misrepresented to regulators and the public.
[15] In Condescendence 2.4(a) reference is made to a large number of studies on the efficacy of Celebrex generally said to indicate cardiovascular and other risks and it is then averred:
“From 2005, Dr Reuben, an anaesthesiologist funded by the defenders, wrote substantially fraudulent articles in the medical press, commending the use of Celebrex.”
[16] In Condescendence 2.5 the pursuers aver generally that :
“From 1999 to 2004, the defenders maintained to the public (and GPs) that Celebrex (and indeed Bextra) were wholly safe painkillers without side effects. That claim was false as the defenders well knew. It was maintained by them that this claim was based upon the results of scientific studies.”
Specific examples of representations attributed to Pfizer Inc. follow and it is said that they now accept that conclusions offered by scientists employed by the defenders in the Journal of the American Medical Association (JAMA) on 13 September 2000 were false and the averments continue:
“Accordingly, it was known to the defenders by 1999 that there was evidence of a significant increased risk in CV problems but that was not disclosed to the public or GPs. The FDA was similarly misled by the defenders as to the safety of Celebrex.”
[17] In Condescendence 2.6 averments are made to the effect that COX‑2 inhibitors increase the likelihood of blood clot formation such that the risks of stroke and myocardial infarction are increased and continue:
“Patients not at risk previously could become at risk; and those already at risk had an increased risk of adverse effect. That increase in risk is a material risk, being more than de minimis. 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. The authors of the study reported a statistically significant increased risk of CV problems. That conclusion was concealed by the defenders from the public, the FDA and GPs. It was not made publicly available until 2005.”
[18] In Condescendence 2.7, the pursuers make averments about the circumstances of the withdrawal of Vioxx from the market in September 2004 and an acknowledgment by the defenders that their own product, Bextra, was cardiotoxic and continue:
“In December 2004, the defenders began advising the public and GPs that Celebrex increases the risk of heart attacks and CV problems.”
[19] In Condescendence 2.8 the pursuers aver that on 1 February 2006 Pfizer made an admission to the New York Times as to the risks of heart problems associated with taking Celebrex and in particular that:
“[the 1999 CLASS study] found that the number of Celebrex patients suffering heart attacks was almost four times that of those taking a placebo.”
[20] The pleadings continue:
“2.9 On 7th April 2005, in the USA, Pfizer agreed to insert a ‘black box’ warning on the Celebrex label.
2.10 A ‘black box warning’ is the highest level of warning that can be inserted on such a product prior to requiring withdrawal from the market.
2.11 It stated ‘CELEBREX may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal.’
2.12 That warning and the acceptance by the defenders of the requirement that it be placed on the product, was based upon data known to the defenders and factually accurate information available.
2.13 The website of Pfizer currently states ‘Important Information: CELEBREX may increase the chance of a heart attack or stroke that can lead to death.’
2.14 The statement on the website of the defenders referred to in 2.13 is true and accurate.
2.15 The statement on the website of the defenders referred to in 2.13 has always been true and accurate.”
[21] In Condescendence 2.19 the pursuers aver that:
“In October 2004, the defenders said that no completed study had ever shown any increased cardiovascular risks arising from Celebrex. In an article by Andrew Pollack, published in the New York Times on 19 October 2004, Dr. Gail Cawkwell, the defenders’ medical team leader for Celebrex, made the claim Celebrex had been shown to reduce cardiovascular risk. That claim was misleading.”
and that;
“…the CLASS study was not published and the data was not sent to the FDA until June 2001, some 4 months after the FDA announced a major review of the safety of Vioxx and Celebrex. The FDA panel which carried out the review recommended that Vioxx carry a warning label about cardiovascular risk, but did not make the same recommendation for Celebrex. Dr Kenneth Brandt, one of the members of the review, subsequently said that he had not been aware of the CLASS study and would have made a different decision on the Celebrex warning label if he had.”
[22] In Condescendence 4, it is averred that use of Celebrex materially increases the risk of CV events such as heart attack and stroke and that the defenders did not warn of that risk on the PIL or in any other literature provided to prescribing doctors.
[23] In Condescendence 5, the pursuer Mr Richards avers that he has a history of soreness and stiffness in his joints and that he has taken a number of painkilling medicines. In July 2002, he was prescribed a dose of 200mg per day of Celebrex on the advice of his GP. It proved effective in treating his soreness and stiffness so that he took it each day. He suffered a heart attack on 12 May 2014 and on 27 January 2005 was advised by his GP to stop taking Celebrex because of reports that the drug caused heart attacks and strokes. The pursuer continues to take analgesics for soreness and stiffness in his joints.
[24] The pursuer Mr Jarvie avers at Condescendence 5 a history of cervical and lumbar spondylosis such that he took analgesia for back pain. Since he also had oesophagitis he was advised not to use the NSAID Diclofenac. In February 2001 he found that a side effect of his taking Vioxx on prescription was bloating. On 31 May 2002 he was prescribed a daily dose of 200mg of Celebrex having complained of pain in his left arm, elbow and shoulder. He took it daily until 3 December 2004. He suffered a stroke on 21 November 2003 and again on 11 May 2004
[25] In Condescendence 6, parts of which are quoted at paragraph [41] below, the pursuers make averments as to defects and dangers inherent in taking Celebrex; the defenders’ knowledge ; the duties said to be incumbent on them; failure to fulfil those duties and causation with reference to subsequent averments as to the medical events founded on.
[26] In Condescendence 7, the pursuers aver that the defenders are in breach of duties to the pursuers in terms of section 2 of the Consumer Protection Act 1987 and quote section 3 to the effect that 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 they were entitled to expect that it would not carry “the high risk of adverse CV events such as that which befell the pursuer” and that they were entitled to expect that Celebrex would not cause or materially contribute to the CV event suffered without a clear warning being given to that effect. They go on to aver that the defenders knew that their product was defective and that “had the warnings been provided from the outset few if any doctors in the UK would have prescribed the medication.”
[27] In Condescendence 8, Mr Richards avers that:
“As a consequence of the defenders’ fault, negligence and breach of statutory duty the pursuer suffered loss, injury and damage. On 12 May 2004, he suffered a myocardial infarction.”
[28] In Condescendence 8, Mr Jarvie avers that:
“As a consequence of the defenders’ fault, negligence and breach of statutory duty the pursuer suffered loss, injury and damage.”
He goes on to aver that he suffered strokes on 21 November 2003 and 11 May 2004 and the circumstances of those events.
The Debate
[29] The defenders intimated a single note of argument which senior counsel adopted in his submissions without rehearsing its entire content. Senior counsel for the pursuers had prepared a single note of argument on behalf of both pursuers. In the course of his submissions he lodged two tables containing detailed responses to the criticisms made of the pleadings. I have considered all of the written and oral submissions made and I do not intend to rehearse all of them at this stage. There were two principal lines of attack: first that the pursuers had not pled a relevant case, particularly having regard to the detailed averments made in answer; and, secondly, that in a case where there were averments of fraud and deceit, the pursuers had not met the high standard of specification required.
Submissions on Relevancy
Defenders
[30] In his written and oral submissions, senior counsel repeatedly drew attention to the detailed answers made to the pursuers’ averments which include references to studies which have found no significant risk of CV events associated with Celebrex. Counsel suggested that in the light of the answers, the court must give particularly close scrutiny to the pursuers’ averments which would then be found wanting. Counsel was unable to provide any authority vouching this approach and ultimately changed tack by suggesting that the value of the answers when assessing relevancy was that they highlighted intrinsic deficiencies in the pursuers’ pleadings. He accepted that on the issue of relevancy it was the pursuers’ pleadings themselves which should be examined and that they should be taken pro veritate.
[31] He argued that the pursuers were basing their case on proving an increased risk of adverse serious CV events. Even if they could do so, their task in proving that Celebrex is a defective product is a difficult one since it continues to be licensed for use in both the UK and the USA. The pursuers’ averments as to the level of increased risk were inconsistent, varying between a risk ratio of less than 2 and 3.4. They may not be sufficient because, as Lord Toulson noted in Williams v Bermuda Hospitals Board (NHS Litigation Authority intervening) [2016] AC 888, a tiny risk doubled will still be very small.
[32] It was insufficient for the pursuers to rely on studies which compared the use of Celebrex against taking a placebo because that was not the position of the two pursuers. In each case they suffered ongoing symptoms such that both before and after they were prescribed Celebrex, they were prescribed other NSAIDs.
[33] Since in Scotland the highest prescription ever allowed was 400mg per day of Celebrex, and both of the pursuers had been prescribed 200mg, it was irrelevant to plead the consequences of taking more than 400mg per day which was the focus of some of the studies averred.
[34] Senior counsel apprehended that the pursuers seek to prove causation on an analysis comparable to that approved by the House of Lords in Fairchild v Glenhaven Funeral Services Ltd and Others [2003] 1 AC 32 and submitted that the averments were insufficient for that purpose.
[35] In Sienkiwicz v Greif (UK) Ltd [2011] 2 AC 229, at paragraph 170, Lady Hale stated, obiter, that in cases where the Fairchild exception does not apply, “doubling the risk” is not an appropriate test of causation. The pursuers’ averments might be considered to take that illegitimate approach.
Pursuers
[36] Senior counsel submitted that it was only the pursuers’ pleadings which ought to be examined to determine relevancy. The pursuers sought to demonstrate essential parts of their cases by two routes. First by inferences to be drawn, supported by expert opinion to be adduced at proof, from the various studies about which the pursuers had made averments; and secondly by proving extra-judicial admissions made by or on behalf of the defenders and actions taken by them from which inferences could be drawn as to dangers associated with Celebrex which had been present from the outset. Warnings later issued by the defenders could be relevant both to the common law case and the statutory case.
[37] It was not essential to list studies in order to plead a relevant case but the pursuers had sought to give notice of lines to be pursued. The court could not resolve the value of the studies pled on either side at debate. The pursuers have expert opinion available to them to support the pleadings and it was a matter for proof to determine the value of the various studies founded on by each side. The relevant expert report was lodged, despite the defenders suggesting otherwise. Whilst it was accepted that the pursuers were only ever prescribed 200mg per day, experts could make judgments and draw inferences from the whole range of studies averred.
[38] Statistical probabilities may have a part to play in expert opinion which would be adduced, but that was not the basis of the claim. What conclusions could be reached from different surveys and the value of placebo or alternative therapy tests were complex matters on which the pursuers relied on statisticians and epidemiologists and these were matters for proof.
[39] The pursuers were not seeking to suggest that the use of Celebrex increased one risk amongst a number of risks on an analogy with the principle expounded in Fairchild. It was the defenders who had introduced suggestions of other possible causes. The pursuers’ case was that the heart attack and the strokes were caused by the ingestion of Celebrex over a significant period of time. In order to prove that, the pursuers would have to prove that consumption of Celebrex caused or made a material contribution to the episodes founded on, that test recently being endorsed by the Supreme Court in Williams. The pursuers made their position clear in Condescendence 6 in each case. It was a matter for proof whether the pursuers could prove causation and not a matter of relevancy.
Decision on Relevancy
The Common Law Case
[40] Whilst 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.
[41] The pursuer Mr Richards avers in Condescendence 8 that as a consequence of the defenders’ fault and negligence [and breach of statutory duty] he suffered injury and damage, specified as being a myocardial infarction on 12 May 2004 causing him certain losses specified in Condescendence 8. He avers in Condescendence 5 that he had been taking Celebrex on prescription from July 2002 until January 2005. He makes averments in Condescendence 6 as to causation, fault and negligence, the defenders’ state of knowledge, the duties which he maintains were incumbent on the defenders and avers that but for their failure to fulfil those duties he would not have suffered loss, injury and damage:
“6. The pursuer’s injuries were caused by the fault and negligence on the part of the defenders. In prescribing Celebrex the pursuer’s GP reasonably relied upon the defenders or their agents to disclose information of any known defects, risks, dangers or side effects. In using the drug the pursuer reasonably relied upon the defenders and their agents to disclose information of any known defects, risks, dangers or side effects and to disclose that to his GP and to him. The defenders knew or ought to have known that GPs and patients like the pursuer would rely on them to provide sufficient and clear warning of any side effects or risks associated with the taking of the drug (such as the ‘black box’ warning and the warning on their website publicly disseminated but not until after the pursuer had taken the said medication). They knew or ought to have known that Celebrex carried the risk of increased cardiovascular events for long term users of the drug.”
He goes on to aver that:
“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 adverse cardiovascular events including heart attacks, strokes and myocardial infarction associated with long terms use of Celebrex. They did not do so until after the pursuer had ceased taking the medication,”
and that
“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…”
[42] The pursuer Mr Jarvie avers in Condescendence 5 that cervical and lumbar spondylosis caused him to retire from working as a coal miner in 1990 and that he regularly took analgesia. On or about 3 May 2002 he was suffering from pain in his left arm and he took Celebrex on prescription from May 2002 until December 2004. Mr Jarvie makes the same averments at Condescendence 6 as those quoted in in the preceding paragraph. Mr Jarvie avers in Condescendence 8 that as a consequence of the defenders’ fault and negligence [and breach of statutory duty] he suffered injury and damage, specified as being strokes which he suffered on 21 November 2003 and 11 May 2004 causing him certain losses specified in Condescendence 8.
[43] Whilst the route taken is not as direct as it might have been, ultimately, the pursuers identify the medical events founded on and the associated losses. 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, ie it made a material contribution to, the medical event(s) on which he founds. Nowhere in their pleadings do they seek to establish causation on the principle discussed in Fairchild or by some analogy with it and Mr Smith confirmed that they will not seek to do so. In my view 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 Statutory Case
[44] It is not in controversy that Celebrex falls within the definition of product in section 1 of the Act. Sections 2, 3 and 4 are in these terms
“2.— Liability for defective products.
(1) Subject to the following provisions of this Part, where any damage is caused wholly or partly by a defect in a product, every person to whom subsection (2) applies shall be liable for the damage.
(2) This subsection applies to—
(a) the producer of the product;
(b) any person who, by putting his name on the product or using a trade mark or other distinguishing mark in relation to the product, has held himself out to be the producer of the product;
(c) any person who has imported the product into a member State from a place outside the member States in order, in the course of any business of his, to supply it to another.
(3) Subject as aforesaid, where any damage is caused wholly or partly by a defect in a product, any person who supplied the product (whether to the person who suffered the damage, to the producer of any product in which the product in question is comprised or to any other person) shall be liable for the damage if—
(a) the person who suffered the damage requests the supplier to identify one or more of the persons (whether still in existence or not) to whom subsection (2) above applies in relation to the product;
(b) that request is made within a reasonable period after the damage occurs and at a time when it is not reasonably practicable for the person making the request to identify all those persons; and
(c) the supplier fails, within a reasonable period after receiving the request, either to comply with the request or to identify the person who supplied the product to him.
(5) Where two or more persons are liable by virtue of this Part for the same damage, their liability shall be joint and several.
(6) This section shall be without prejudice to any liability arising otherwise than by virtue of this Part.
3.— Meaning of ‘defect’.
(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.
4.— Defences.
(1) In any civil proceedings by virtue of this Part against any person (‘the person proceeded against’) in respect of a defect in a product it shall be a defence for him to show—
…
(e) that the state of scientific and technical knowledge at the relevant time was not such that a producer of products of the same description as the product in question might be expected to have discovered the defect if it had existed in his products while they were under his control; or
…
(2) In this section ‘the relevant time’ ...means—
(a) if the person proceeded against is a person to whom subsection (2) of section 2 above applies in relation to the product, the time when he supplied the product to another;
(b) if that subsection does not apply to that person in relation to the product, the time when the product was last supplied by a person to whom that subsection does apply in relation to the product.”
[45] The pursuers aver in Condescendence 8 that as a consequence of the defenders’ breach of statutory duty they suffered the injury and damage specified. The averments discussed in the context of the common law case are also relevant to the statutory case and the pursuers seek to establish the statutory case by averring in Condescendence 7 that Celebrex is a defective product within the meaning of the 1987 Act such that the defenders are liable under section 2 for damage caused having regard to the definition of a defect in a product provided in section 3. They go on to aver that consumers of Celebrex:
“…were entitled to expect that it would not carry the high risk of adverse cardiovascular events, such as that which befell the pursuer …”
and that each pursuer was entitled to expect that:
“…Celebrex would not cause or materially contribute to the cardiovascular event suffered without a clear warning being given to that effect”
They go on to aver that:
“… the defenders are liable for the loss, injury and damage suffered as a consequence of the said defect in Celebrex”
and that:
“Not only was the product defective, the defenders knew it to be so.”
In the remainder of Condescendence 7 the pursuers make averments giving notice of the basis on which they will seek to prove that Celebrex was a defective product at the time when they were taking it on prescription.
[46] Having examined the pursuers’ pleadings in the light of all the submissions advanced, both orally and in writing, I do not find it necessary individually to address each of the detailed points set out at paragraphs 4-17 of the defenders’ note of argument. Many of the points proceed on a misunderstanding of the case being pled. Averments concerning the defenders’ application for marketing in the USA are potentially relevant to rebut the statutory defence under section 4 (1) (e).
[47] Neither on the statutory case nor that of common law fault do I consider that even if the pursuers succeed in proving all that they aver still their case must fail. As I was invited to do by Mr Smith for the pursuers, I will allow parties proof before answer on their respective averments and reserve the first plea in law for the defenders and repel the third and fourth pleas in law for the pursuers.
Submissions on Specification
Defenders
[48] Senior counsel for the defenders referred to text books and case-law concerning the particular pleading requirements where fraud is averred:
Lees, “A Handbook of Written and Oral Pleading in the Sheriff Court” at paragraph 93; Maclaren, “Court of Session Practice” at page 390; Milne & Co v Aberdeen District Committee and Another 1899 (1899) 7 SLT 259; Thomson (R H) & Co v Pattison, Elder & Co (1895)22 R 432; Royal Bank of Scotland v Holmes 1999 SLT 563; Kidd v Paull & Williamsons LLP [2017] CSOH 16; Semple Cochrane Plc v Clark 2003 SLT 532; Buchanan (Stewart) Gauges Ltd v BEC (Scotland) Ltd (2001 GWD 3-126); Parks of Hamilton (Holdings) Ltd v Campbell [2013] CSOH 67. He also referred to cases which were founded on by the pursuers; Derry v Peek (1889) 14 App Cas 337; Mair v Riogrande 1913 SC HL 74; Bile Bean Manufacturing Co Ltd v Davidson (1906) 8 F 1181.
[49] The decision in Thomson demonstrated that fraud was a personal act such that fraud by one partner did not necessarily render the whole partnership liable for the consequences of a fraud and the same principle applied to a company. Accordingly it was necessary when averring fraud to identify the person who made the representation or committed the fraudulent act.
[50] The defenders founded particularly on the opinion of Lord Macfadyen in Royal Bank of Scotland and on paragraph 14 of Lord Macfadyen’s unreported opinion in Buchanan (quoted by Judge Thomson QC in Semple at paragraph 39) which support the view that a high standard of specification is required in any circumstance where fraud was alleged for any purpose. It was accepted that the underlying principle was fair notice but, nevertheless, what was required was specification of the matters enumerated by Lord Macfadyen and the cases founded on by the defenders did not demonstrate the contrary. Counsel accepted that it was possible to raise an action of fraud against a corporation which could be found liable (Derry) but in that case, the directors issued a false prospectus and were sued in their own names. The position in that case was similar to Lord Macfadyen’s example of false representations being made in a signed letter. In Mair, the individual concerned and the representation were identified in the pleadings. Nothing could be taken from Bile Bean which simply vouched that the court would not grant interdict to protect a fraudulent enterprise.
[51] Senior counsel contended that the pursuers are averring a deliberate delict, a malicious wrong, and that they seek to prove fraud on the part of the defenders for which the averments were insufficiently specific in particulars which were set out in detail in the defenders’ note of argument. When averring fraud, it was necessary to specify the fraudulent act or fraudulent representation; the occasion of its doing or making; the circumstances relied on as yielding the inference that that act, omission or representation was fraudulent; and the identity of the person responsible for the act, omission or fraudulent representation. For the most part counsel proceeded by adopting the specific examples contained in his note of argument and inviting the court to examine them.
Submissions for the Pursuers
[52] The court should bear in mind that the pursuers’ grounds of action are common law fault and liability under the Consumer Protection Act 1987 for a defective product. Their ground of action is not fraud. It may not be necessary to prove fraud, but proving knowledge and representations may be pertinent to rebut the statutory defence under section 4(1)(e) of the 1987 Act. Further, if it could be shown that the defenders knowingly made false representations, then that may serve to undermine the value which the court might attribute to the studies on which the defenders seek to rely.
[53] In Royal Bank of Scotland, the allegation of fraud was the only defence stated. The principle underpinning the line of authority founded on by the defenders was identified by Lord Macfadyen in that case and in Buchanan: it was all about giving fair notice and that the nature of the representations could in some cases themselves provide sufficient specification. In this case, the defenders knew perfectly well what representations they had made through their website, to newspapers, to the FDA and EMEA and who made them. In the circumstances of this case, the identification of an individual was sometimes impossible for the pursuers, but it did not matter because the representations were made on behalf of the company. Where there were omissions it would be almost impossible to attribute an omission to a particular person. The pursuers had given as much notice as they were able to in a case where fraud was not the ground of action. In the circumstances of this case, fair notice had been given to the defenders and there was no material prejudice to them arising from the manner in which the case was pled.
Decision on Specification
[54] The cases of Derry, Mair and Bile Bean turn on their own circumstances and do not appear to me to undermine the general requirements of specification where fraud is averred. However, in considering the respective submissions otherwise, it is useful to identify just what the pursuers’ grounds of action are and how the averments complained of relate to them. They are common law fault and a defective product claim under the Consumer Protection Act 1987. The pursuers are not seeking to prove their claim on the ground of fraud and whilst that is not the end of the matter, it is important to keep in view that in many of the cases founded upon, it was sought to prove fraud either as a ground of action for the pursuer or as a defence. In Royal Bank of Scotland, a sufficiently averred fraud on the part of a third party could have founded a defence in the particular circumstances of that case. It is against that background that the various dicta should be understood.
[55] Lord Macfadyen wrote the following in Royal Bank of Scotland, at 569K -570E:
“The issue thus comes to be whether the defender has pled the fraud exception with sufficient specification. I am in no doubt that Professor McBryde is correct in stating that it is settled law that there must be specific averments of fraud. That is amply borne out by the authorities cited in the course of the debate. It is in my view essential for the party alleging fraud clearly and specifically to identify the act or representation founded upon, the occasion on which the act was committed or the representation made, and the circumstances relied on as yielding the inference that that act or representation was fraudulent. It is also, in my view, essential that the person who committed the fraudulent act or made the fraudulent misrepresentation be identified. Counsel for the defender suggested that what was said in Thomson & Co v Pattison, Elder & Co. about the need to identify the individual was said in the context of partnership, where questions of relief between the innocent partners and the guilty partner might arise, and did not apply in other circumstances. It seems to me, however, that it will not do to say that a fraud has been perpetrated by Lloyd's, without further specification. The Society of *570 Lloyd's, like a partnership or company or other corporate body, must, if it commits a fraud, do so through the medium of one or more individuals. It seems to me that the need to give fair notice of the identity of the alleged perpetrator is as great when the fraud is said to have been committed by Lloyd's as it is when the fraud is alleged against a partnership.
There may be circumstances in which identification of the specific act founded on operates as sufficient identification of the perpetrator (for example, where a fraudulent statement is said to have been made in a specified letter), but in principle identification of the alleged perpetrator is in my view essential. I do not consider that counsel for the defenders was well founded in his attempt to distinguish the authorities about the need for specific pleadings of fraud on the basis that they were developed in cases in which the person allegedly responsible for the fraud was a party to the proceedings, whereas here Lloyd's are not a party to the present action. It is no doubt correct that that was the context in which the line of authority developed, but in my opinion the need for specification is present a fortiori in a case where the party against whom the fraud is pled as a defence to his claim is not the person alleged to have been responsible for the fraud. In such a situation the pursuers are in at least as much need of fair notice of precisely what is alleged against Lloyd's as Lloyd's would be if the point were pled directly against them. …. I am therefore satisfied that in judging the adequacy of the specification of the defender's averments of fraud on the part of Lloyd's, it is appropriate to apply the rigorous standards laid down in the authorities.”
Paragraph 14 of Lord Macfadyen’s unreported opinion in Buchanan (as quoted by Judge Thomson QC in Semple at paragraph 39) was to this effect:
“It seems to me that, in identifying the tests which averments of fraudulent misrepresentation must pass, it is worth making the distinction between relevancy and specification. So far as relevancy is concerned, to make a case that a contract was induced by fraudulent misrepresentation, the pursuer must in my opinion set out in averment (i) the representation that was made, (ii) that the representation was false, (iii) that the maker of the representation knew when he made it that it was false (or acted recklessly, in that he did not know and was indifferent to whether it was true or false), (iv) that the maker of the representation, if not the defender, was one for whose actings the defender was in law answerable, and (v) that the pursuer was induced by the representation to enter into the contract in question. So far as specification is concerned, the authorities in my view justify the conclusion that when fraud is alleged, a high standard of specification is required. It seems to me that it is appropriate to bear in mind that the rule requiring pleadings to be specific is founded in fairness. 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. Subject to that point, however, it must in my view be borne in mind that the strict standard of specification will be applied to each of the essential elements of the case identified above.”
Judge Thomson, having quoted this passage, stated:
“I agree. In my opinion the same considerations of fairness, which are related to the gravity of the charge, apply to averments of fraud in the context of an action based on breach of contract as they do in an action based on delict…”
[56] In the passage quoted from Buchanan, Lord Macfadyen both endorsed and expanded upon the import of his opinion in Royal Bank of Scotland explaining that it is considerations of fairness and fair notice which generally require a high standard of specification in cases where fraud is averred. What fair notice requires generally is that the defenders are not put in a position where they do not know the case to be made against them and are at risk of being taken by surprise at the proof. It is not difficult to see that the defenders’ averments in Royal Bank of Scotland would have left the pursuers in that position where the averments of fraud related to a third party and there was little or no specification. Enough specification must be given to enable the defenders to identify what is being alleged against them and to prepare their case. On this issue counsel for the pursuers referred to some of the answers given as providing an indication that the defenders were not in ignorance of the case made against them and were well able to meet it. Counsel for the defenders did not suggest that for this purpose the court could not consider the answers. I also bear in mind in considering each of the specific complaints made by the defenders, that if the pursuers seek to lead evidence in relation to which no fair notice has been given, the defenders can object and seek to have the evidence excluded.
[57] Twenty‑one enumerated points were taken under the banner of specification where fraud is averred in the defenders’ note of argument and I have examined each specified complaint. At most points the defender asks for 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 points appear at paragraph 19 of the defenders’ Note of Argument, and I number them accordingly.
[58] 19(i) [Condescendence 2.3] In the preparation of the SPC for Celebrex, material information was omitted by the defenders. It is true that it is not specified which person or people was or were responsible for this omission, but the pursuers aver what was omitted four sentences later:
“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, such as myocardial infarction, stroke or sudden cardiac death.”
Earlier averments in Condescendence 2.3 were in these terms:
“The SPC proposed by the defenders made no reference to increased risk of adverse serious cardiovascular events caused by Celebrex.”
[59] 19(ii) [Condescendence 2.3] The defenders omitted to provide data from the CLASS study to the EMEA when it became available to the defenders. Again it is not specified which person or people was or were responsible for this omission, but from averments which follow, it becomes clear that what is said to have been omitted is averred at lines 22-26 of Condescendence 2.4:
“…the defenders commissioned a study, the Celecoxib Long Term Arthritis Safety Study (“CLASS”) study number N49-98-02-035. By 1999, the defenders were aware of the significant risks to patients taking Celebrex. That knowledge was derived from the results of studies carried out by them and on their behalf, which studies were designed to obtain data to establish the safety of the medication.”
[60] 19(iii) [Condescendence 2.3] They omitted to include other data and studies (hereinafter averred) indicating a statistically significant increased risk of cardiovascular events. Again it is not specified which person or people was or were responsible for this omission, but the subsequent averments signalled are found at lines 1-18 of Condescendence 2.4 where reference is made to a number of studies which provide specification relating to the averment complained of.
[61] I would observe relative to each of the three preceding specification points that it must be known to the defenders who prepared their proposed SPC and passed it on to regulatory authorities. At answer 6.3 they are able to aver the contents of the SPC at different points in time. At the end of answer 6.5 they aver that they will produce tables showing the SMC and PIL information applicable to Celebrex from time to time. Their answers at 2.3, 2.5.1 and 6 provide substantial detail in response and demonstrate that the defenders understand the points being made and how to counter them.
[62] 19 (iv) [Condescendence 2.3] It was maintained by the defenders that Celebrex was safer than Vioxx in respect of CV safety, despite their knowing from their own and other studies that there were significant CV risks. It is not specified which person or people was or were responsible for this representation, but it is later averred with reference to 30 September 2004, at condescendence 2.7 that:
“The FDA warned of the potential problems of Vioxx. The defenders, however, maintained that Celebrex had shown no CV risk and so stated in public statements”
and again at 2.18 that:
“Following withdrawal by Merck of Vioxx from the market, in 2005, the defenders consistently (and falsely) stated that not only was Celebrex fundamentally different in its composition, but there were data indicating that there was in fact evidence of cardio protection from the use of Celebrex”
and in 2.19 the pursuers make the averments first quoted in paragraph [21] above. The pursuers have averred the studies on which they base their contentions generally. The defenders are likely to know what statements were made on their behalf. However, if the pursuers seek to lead evidence at proof which truly catches them by surprise, the defenders can object and seek to have it excluded.
[63] 19 (v) [Condescendence 2.3] [As is hereinafter averred, as a pharmaceutical product, Celebrex was defective;] and the defects in its function were known to the defenders but concealed from the public and those who were responsible for sanctioning it release on to the market. It is believed and averred that that concealment was motivated by the desire to maximise the commercial value of the product. This appears to refer back to averments complained of at points 19(i) and 19(ii) – the omissions were from the proposed SPC and an averred failure to update EMEA. The 18 lines at the start of Condescendence 2.4 provide specification of defects. Reference to the CLASS study in Condescendence 2.6 and 2.19 provides further specification:
“2.6 …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. The authors of the study reported a statistically significant increased risk of CV problems. That conclusion was concealed by the defenders from the public, the FDA and GPs. It was not made publicly available until 2005.
2.19 The defenders released the CLASS study into the public domain on the United States based website ‘www.clinicaltrials.gov’ in around January 2005, some 5 years following its conclusion and nearly 4 years after the data was belatedly presented to the FDA. There was no public announcement by the defenders, for example in the media or on their own website, that the CLASS study was released into the public domain.”
[64] The final sentence of the averments complained of signals that the court may be invited to draw an inference from other proved facts. Whether the court is able to draw such an inference, and whether it feels it necessary to do so in order to resolve the central issues between the parties, can be determined once the facts have been established at proof.
[65] 19(vi) [Condescendence 2.3] As in fact occurred, once the true effects were disclosed, the profits from that medication fell dramatically Once again, it appears to me that the “true effects” which the pursuers hope to prove are those alluded to in Condescendence 2.4
[66] 19(vii) [Condescendence 2.4] The results were falsified and manipulated to present a false picture to the regulators and to the public [and as a consequence the defenders profited from that deceit] Read in context, I consider that what is intended is an allegation that the defenders misrepresented results to others and I do not understand that, for the most part, the pursuers are averring that those conducting research falsified or manipulated results. As the defenders’ acknowledge in their note of argument there is at least specification of the “CLASS” study N49‑98‑02‑35. There is a reference to benefits proved in that study being published in JAMA but that data relating to “increased CV problems” is said not to have been published until several years later. It is averred that only part of the trial was used to demonstrate gastro-intestinal benefits.
[67] The last six lines of Condescendence 2.4 provide further specification:
“A further study in June 2003 indicated that another COX 2 type product manufactured by the defenders (Bextra) was harmful from a CV perspective, but concealed from the public. The defenders sent only part of the data to the FDA, seeking to support their position that the GI advantages of Celebrex were superior to traditional NSAIDs, but did not disclose the part of the study that showed an increased risk of CV problems.”
These appear to be the manipulations and/or falsifications being alluded to.
[68] In the averments complained of at 19(vii) the pursuers are essentially alleging fraud and it is reasonable to expect sufficiently precise specification so as to give fair notice. In so far as the CLASS study is concerned, there is no date specified for the publication in JAMA at this point and no employee is named, but I consider that sufficient is averred for the defenders to have fair notice of the case made against them. They are able to identify the precise article in answer 2.4 and to make a specific denial that any data relevant to increased CV events was omitted and to make detailed averments about it at answer 2.4.2.
[69] Another passage complained of under 19(vii) comes later in Condescendence 2.4:
In particular, the senior management of the defenders were aware of the results of the studies that indicated a positive CV risk.
It is true that no specific member of the management is identified, but given what has been averred about studies made known to the defenders and commissioned by them, I consider that, if these matters are proved, the court could infer that those controlling the company must have been aware of them. The defenders’ management must know or be able to ascertain what was known about the studies referred to and I am not persuaded that they will necessarily suffer material prejudice. It remains open to them to object to the eliciting of evidence at proof if matters emerge of which there is insufficient notice, but I am not at this stage persuaded to exclude these averments from probation even allowing for the import of the cases founded on by the defenders.
[70] 19(viii) The defenders accordingly showed a willingness to manipulate raw data to influence the ultimate opinion in the studies. [the emphasis is mine.] This is a serious allegation. I can identify little justification for it in the pleadings and no obvious source of specification. It is so vague that I am not satisfied that the defenders have fair notice. It could be that this is a typographical error and that what is really meant is the perception by others of the results of the studies and the use of the word “accordingly” may support that construction, but that is not what is averred in this sentence as it stands. Hitherto the pleadings complained of seem to relate to the manner in which study results and data were presented to others, but this sentence currently avers something different. I shall exclude from probation the sentence in Condescendence 2.4:
“The defenders accordingly showed a willingness to manipulate raw data to influence the ultimate opinion in the studies.”
[71] 19(ix) [Condescendence 2.4] It is believed and averred that this selective release of data was effected inter alia by the defenders on account of the fact that they knew at that stage that it revealed significant cardio vascular risk. For the reasons previously discussed, the CLASS study is specified and averments are made as to selective release of data. The pursuers signal that they invite the inference of knowledge, which would be relevant both to their statutory case and their case at common law.
[72] 19 (x) [Condescendence 2.4] From 2005, Dr Reuben, an anaesthesiologist funded by the defenders wrote substantially fraudulent articles in the medical press, commending use of Celebrex. On the face of it, there is very little specification given here which could raise a sharp issue of fair notice. The averment complained of is made in Condescendence 2.4(a) and is met with a non-specific denial at page 29 of the Richards record. Whilst questions of fair notice ought, in principle, to be resolved in the light of the current record in the case of the pursuer Mr Richards, the averments in both his record and that of Mr Jarvie were treated as interchangeable in the course of the debate. It would be wholly artificial to ignore what is averred in answer to Condescendence 2.4(a) in the case brought by Mr Jarvie.
“2.4(a) Admitted that the defenders conducted certain studies. Reference is made to the document ‘Clinical Trials Investigating Celebrex Referenced by the Pursuers’, the terms of which are incorporated herein for the sake of brevity. Quoad ultra denied. Explained and averred that, with respect to the averments about Dr Reuben, he was an American anaesthesiologist. He was Professor of Anaesthesiology and Pain Medicine at Tufts University, Boston and Chief of Acute Pain at Baystate Medical Center, Springfield. Dr Reuben wrote a number of research papers and journal articles in relation to pain management. He has subsequently admitted that many of the data underlying his research were fabricated. Dr Reuben’s fraudulent activity was directed towards Pfizer as well as other pharmaceutical companies and other researchers. Five Independent investigator-initiated research grant agreements were executed between Pfizer and Baystate Medical Center in relation to Dr Reuben’s work between 2002 and 2007, when Pfizer was unaware of his fraudulent activities. He was subsequently ordered to make restitution payments to Pfizer as a result of the harm done to Pfizer through his fraud.”
The defenders plainly know all about Dr Reuben and are able to respond. Accordingly I do not consider them to be at any disadvantage by virtue of a lack of specification, notwithstanding the use of the term “fraudulent.”
[73] 19(xi) [Condescendence 2.5] The marketing of Celebrex was aggressive and persistent. Those employed as sales representatives. This is not an averment of fraud and in any event the defenders must be aware of their marketing strategy and the role and methods of sales representatives, for what it is worth.
[74] 19(xii) [Condescendence 2.5] The warning labels (when introduced) were obscure and lacked specification. There can be no doubt as to what the labels say if they are produced and spoken to by clinicians and I consider this simply to be notice of a line of evidence. This is not an averment of fraud but viewed in isolation it might be seen to lack specification. I consider that it should be read with preceding and subsequent averments which becomes apparent on reading further into Condescendence 2.5 which refers back, as I understand it, to Condescendence 2.4:
“Had they been clear, GPs would have been alert to the potential problems and would not have prescribed the medication at all, or at least would have fully explained the risks to patients. Patients in the UK generally expect, and reasonably expect, that GPs who prescribe medication to them have taken proper account of their medical history and considered all relevant warnings of adverse effects. As is averred above, 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 significant increased CV risk to patients.”
[75] 19(xiii) [Condescendence 2.5] From 1999 to 2004, the defenders maintained to the public (and GPs) that Celebrex (and indeed Bextra) were wholly safe painkillers without side effects. That claim was false as the defenders well knew. That averment goes most of the way to averring fraud, and a later averment in Condescendence 2.5, to the effect that this was designed to mislead the public and prescribers, goes at least as far as averring attempted fraud.
[76] There is an undated reference to a press release by Pfizer in the Journal of Clinical Pharmacology the essence of which is quoted but the defenders are able to supply the date in their answer at 2.5.4: 15 February 2000. There is reference to a press release by Pfizer dated 17 April 2000 the essence of which is quoted; and a reference to an article in JAMA dated 13 September 2000. It is averred that the authors of the JAMA study were employees of the defenders.
[77] Even though not every detail which might be necessary for full specification is present, I am satisfied that the defenders have fair notice of the case they have to meet. Their answers at 2.5.5 and 2.5.6 make it abundantly clear that the defenders know all about these articles and can respond to them. Their answer at 2.5.6 demonstrates that they know who the sixteen authors were.
[78] 19(xiv) [Condescendence 2.6] [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. Whether or not there is inconsistency with any prior averment I am not persuaded that it can be said that there is a lack of specification such that the defenders cannot know the case they have to meet.
[79] 19(xv) [Condescendence 2.7] The defenders, however, maintained that Celebrex had shown no CV risk and so stated in public statements. Whilst there is no clear specification at this point, it is apparent that the relevant time frame is in or after September 2004 and the averments at Condescendence 2.18 and 2.19 provide specification.
[80] 19(xvi) [Condescendence 2.18] Following withdrawal by Merck of Vioxx from the market, in 2005, the defenders consistently (and falsely) stated that not only was Celebrex fundamentally different in its composition. Condescendence 19(xvii) [Condescendence 2.19] In October 2004, the defenders said that no completed study had ever shown any increased cardiovascular risks arising from Celebrex. Whilst the averments are not as clear as they might be, I take the passage in Condescendence 18 to be a reference to the article referred to in Condescendence 2.19 by Andrew Pollack in the New York Times on 19 October 2004 quoting Dr Gail Cawkwell, an employee of the defenders which is also specification of the general proposition about October 2004 contained in Condescendence 2.19. I note also that in answer 2.18 the defenders aver that Celebrex is fundamentally different in composition from Vioxx.
[81] 19(xviii) [Condescendence 2.19] The defenders subsequently admitted that the CLASS study showed a statistically significant increase in cardiovascular risk from Celebrex. This is not an averment of fraud and whilst there is a lack of specification at this point, it could be a reference to the averments in the last two sentences of Condescendence 2.6 or the terms of Condescendence 2.9. I consider that the defenders must know whether or not they made such an admission and, if so, in what circumstances they did so. If they do not, and evidence is sought led which is not foreshadowed in the pleadings to which I have referred, it is open to the defenders to object to it at proof.
[82] 19(xix) [Condescendence 4] The marketing by the defenders of Celebrex and Bextra would have led any reasonable consumer to believe that it was safe and effective, without any dramatic side effects. This appears to me to be an attempt to encapsulate what has already been pled and so the defenders have notice. If the pursuers seek to lead evidence on this point which seeks to go beyond the scope of the specification in the pleadings, the defenders can object. The defenders have not been disabled from making the detailed averments in their answers 2.2, 2.18 and 2.19 to which they refer in their answer 4.
[83] 20. Efforts were made by the defenders to have their product on the market before Vioxx… could do so on account of the very significant profits that could be expected from the manufacture of a new medication. This is not an allegation of fraud and it is in any event admitted in answer 2.3 that the FDA approved the marketing of Celebrex before Vioxx. What is being driven at is motivation and if the pursuers try to elicit evidence of any specific effort of which notice has not been given and which puts the defenders at an unfair disadvantage, they can object.
[84] Point 21 contains a general suggestion that it is not specified how the studies referred to in Condescendence 2.3 and 2.4 relate to allegations of withholding information. I consider that the purpose of those references is simply giving notice of evidence which may be adduced.
[85] For the foregoing reasons, I am not persuaded that there is such a lack of fair notice that I should exclude the averments complained of from probation, with the one exception identified in paragraph [70] above.
Disposal
[86] I shall exclude from probation the sentence in Condescendence 2.4 which states:
“The defenders accordingly showed a willingness to manipulate raw data to influence the ultimate opinion in the studies.”
[87] I shall otherwise repel the pursuers’ third and fourth pleas in law, reserve the defenders’ first plea in law and before answer allow parties a proof of their respective averments.
[88] I shall reserve meantime all questions of expenses.