(first) Ronald Richards; And (second) John Jarvie Against Pharmacia Limited C/o Pfizer Limited
| Jurisdiction | Scotland |
| Judge | Lord Beckett |
| Neutral Citation | [2017] CSOH 77 |
| Published date | 12 May 2017 |
| Date | 12 May 2017 |
| Court | Court of Session |
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...
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