It was the tragedy of thalidomide in the 1960’s that first brought to the public attention the problems faced by victims in the UK in obtaining compensation from large drug companies with unlimited resources to litigate. Following thalidomide, across Europe governments recognised that there was a need to protect the medical consumer. This provided the stimulus for the Medicines Act 1968, and the Pearson Commission which looked into a system for compensation for personal injuries.
The most common form of medicinal product claim is for defective drugs, but there have been claims for defective heart valves [1], breast implants, contaminated blood products [2], the MMR vaccine [3], the contrast dye Myodil and hip joints [4]. Many other products could provoke litigation if defective, and it is not uncommon to see defective product actions outwith medicinal product claims.
Despite the terms of the Consumer Protection Act 1987 [5], when cases have been litigated in the UK the story does appear to be one of remarkably limited success [6]. The cases are complex and expensive. Where claims have succeeded it has been against the government in some shape or form, such as the successful litigation in the High Court and Court of Appeal in 1997 in the Human Growth Hormone group action and the aforementioned blood products litigation. Relatively few cases have proceeded to final judgment, and there is no reported case in this country where courts have made a finding against a drug manufacturer although there have been a handful of confidential settlements.
The group actions in the benzodiazepine litigation gave rise to numerous procedural difficulties and were eventually struck out as an abuse of process and for want of prosecution [7] 2002 saw the claimants who alleged they had suffered a stroke as a result of the oral contraceptive pill defeated after a 44 day trial, and in 2012 the legal action involving 100 families seeking compensation on behalf of their children against the anti-convulsant Epilim came to a premature end when public funding was withdrawn two weeks before trial [8].
More recently in 2018, claimants in England lost their long battle against DePuy a subsidiary of Johnston and Johnston [9]. They had argued that DePuy International’s Pinnacle Ultamet hip replacement released metal debris into the surrounding tissue and was a defective product under the UK’s product liability law. This led to the abandonment of several actions in the courts of England and Wales against other metal hip manufacturers.
In 2019 in Scotland the Outer House of the Court of Session heard one of a number of actions against Finsbury Orthopaedics and Stryker UK by way of a restricted proof [10]. The claimant had undergone a left and rights sided metal on metal (MoM) total hip replacement. The claim was that the products were defective because their safety was not such as persons were generally entitled to expect in terms of the Act. A preliminary hearing was restricted only to the question of the propensities and risks inherent in the MoM total hip replacements, and whether the product was defective in terms of the act. The case failed, and an appeal has recently been heard by the Scottish Appeal court. The decision was issued on 26 January 2020 and the claimant failed. It is likely that leave will be sought to take the case to the Supreme Court.
A huge number of claims have been raised on behalf of woman dreadfully harmed by the use of vaginal mesh. In 2018 the Scottish courts also heard a legal debate in product cases relating to pelvic mesh products [11]. This followed an earlier decision by Lord Boyd of Duncansby in 2017 [12]. These cases have not yet proceeded to a court hearing.
A significant number of medicinal product cases are brought as group actions with all the problems of complex-multi party litigation. Until recently Scotland did not have a facility to bring group actions although this has recently been rectified. Obtaining funding for medicinal product claims has never been easy for claimants given the vast expense involved in bringing these actions. Access to legal aid has become increasingly difficult over the years and has ceased to be available for most clinical negligence claims in England being replaced by Conditional Fee Agreements (CFA). Most firms have reservations about entering into CFA’s in medicinal product claims given the high risk involved in these claims with one notable exception in England being the Ultamet Pinnacle Litigation.
Previously, funding was closely reviewed and could be withdrawn. One example of this was the group litigation in relation to the MMR vaccine where the Legal Aid Board had initially provided funding but withdrew it seven months before the trial was due to commence. The cost of the failed litigation was estimated to be in the region of 15 million pounds. Funding problems were also experienced in the 1990’s in the benzodiazepine litigation and the Paroxetine/Seroxat litigation also faced funding issues. There had been an order made that the litigation funder give security for the defendant’s costs up to trial of £1.75 million [13]. In the Epilim cases [14] (also known as the Fetal Anticonvulsant Litigation) legal aid funding was withdrawn in 2006 to be reinstated and then withdrawn in 2010 just weeks before the trial on the grounds of insufficient prospects of success. The estimated cost to the public purse was over 3 million pounds.
Product liability claims require specialist expertise and lay people often struggle to understand the provisions of the Act. It is important that those harmed by medicinal products have access to information. I had promised to put something online explaining the law on product liability and I am so pleased that Mark Harvey [15] has agreed to prepare a guest post in this area. The post is the first of a series of posts we hope to produce specific to product liability.
I first met Mark many years ago when I heard him lecture on product liability. He is a partner in the Individual Client Services division of Hugh James. He has vast experience litigating and teaching in the area of product liability. He is the court appointed lead solicitor who coordinated over 1,000 claimants in a group litigation order arising out of the health alert relating to PIP silicone breast implants. He was also the lead solicitor in the Wright Medical Conserve metal on metal hip GLO as well as a member of the claimant’s steering committees in both Pinnacle and Zimmer metal on metal hip GLOs. He negotiated a settlement protocol for patients who alleged they had visual problems from cataract remedial intraocular lenses. He currently represents Mesh victims and those alleging injuries from the Oculentis intraocular lenses. He represents PEOPIL on the European Commission’s Experts Group which is reviewing the scope and currency of the Product Liability Directive.
Thank you to Mark for giving up his valuable time to prepare what is the first post in the area of product liability.
[1] Bjork-Shiley valve manufactured by a subsidiary of Pfizer
[2] A v National Blood Authority [2001] 3 All ER 289; Re HIV Haemophiliac Litigation (1990), [1996] P.I.Q.R P220
[3] Sayers v Smith Kline Beechham Plc [2007] EWHC 1346 (QB) also known as the MMR/MR Vaccine Litigation
[4] Wilkes v Depuy International Ltd [2016] EWHC 3096 (QB)
[5] Implementing the Product Liability Directive 85/374 EEC
[6] Ferguson, P, Pharmaceutical products liablity; 30 years of law reform? [1992] J.R. 226; Ferguson, P,An ill for every pill (1995) 145 N.L.J. 845
[7] AB v John Wyeth & Brother Ltd and Roche Products Ltd [1992] 3 Med L.R 190; AB v John Wyeth & Brother Ltd [1993] 4 Med LR 1; AB v John Wyeth & Brother Ltd [1994] P.I.Q.R p385; AB v John Wyeth & Brother Ltd [1997] 8 Med.L.R. 57
[8] Multiple Claimants v Sanifo-Synthelabo Ltd [2007] EWHC 1860 (QB)
[9] Gee and Others v Depuy International Limited [2018] EWHC 1208 (QB)
[10] John Hastings v Finsbury Orthopaedics and Stryker UK Ltd [2019] CSOH 96
[11] GR v Greater Glasgow Health Board and Johnston and Johnson Medical [2018] CSOH 109
[12] AH v Greater Glasgow Health Board [2017] CSOH 57
[13] Bailey v GlaxoSmithKline (UK) Ltd [2017] EWHC 3195 (QB)
[14] Multiple Claimants v Sanifo-Synthelabo Ltd [2007] EWHC 1860 (QB)
[15] mark.harvey@hughjames.com
