Anthony Frederick Wilkes v Depuy International Ltd
| Jurisdiction | England & Wales |
| Judge | Mr Justice Hickinbottom |
| Judgment Date | 06 December 2016 |
| Neutral Citation | [2016] EWHC 3096 (QB) |
| Docket Number | Case No HQ15P02664 |
| Court | Queen's Bench Division |
| Date | 06 December 2016 |
[2016] EWHC 3096 (QB)
Mr Justice Hickinbottom
Case No HQ15P02664
IN THE HIGH COURT OF JUSTICE
QUEEN'S BENCH DIVISION
Royal Courts of Justice
Strand, London, WC2A 2LL
Timothy Trotman (instructed by Sheldon Davidson Solicitors) for the Claimant
David Myhill (instructed by Kennedys Law LLP) for the Defendant
Hearing dates: 21–23, and 25 November 2016
Further written submissions: 29 November 2016
Approved Judgment
Introduction
In January 2007, at the North Manchester General Hospital ("the NMG Hospital"), the Claimant underwent a surgical procedure to insert an artificial left hip made up of metal components manufactured by the Defendant, one of which was a steel femoral shaft called a "C-Stem". In January 2010, that stem fractured; and, when the artificial components were replaced, there was some evidence of metal debris having been shed around the joint.
In this claim, the Claimant alleges that the fracture and the metallosis were caused by the negligence of the Defendant: but a claim is also brought under the Consumer Protection Act 1987 ("the Act"), the Claimant contending that, when the C-Stem component was put into circulation by the Defendant, there was a "defect" in it, as defined in the Act, because its safety was not such as persons generally were entitled to expect. Damages are claimed on the basis of each cause of action.
On 28 April 2015, Master Cook ordered a trial of a preliminary issue, that was formulated in his Order of 16 December 2015, as follows:
"Having regard to the failure of the C-Stem by fracture (but excluding considerations of metallosis… and negligence….), is the Defendant liable to the Claimant by reason of the matters set out in the Particulars of Claim pursuant to section 3 of the [1987 Act]?"
At the trial of that issue, Timothy Trotman appeared for the Claimant, and David Myhill for the Defendant.
In respect of lay evidence, I heard from the Claimant, and several employees of the Defendant. The Claimant served a statement by the consultant orthopaedic surgeon who performed the procedure at the NMG Hospital in 2007, Mr (now Professor) David Sochart, as evidence upon which he proposed to rely; but, unfortunately, Professor Sochart was not timeously asked by the Claimant to attend court for the trial, and, when he was asked very shortly before the trial, he was unable to attend because of clinical commitments in Ireland. Despite these unhappy circumstances, I allowed his evidence to be admitted; although, as Mr Myhill emphasised, the fact that there was no opportunity to cross-examine Professor Sochart upon it inevitably affects the weight I am able to give it.
The majority of the evidence was from two experts, Mr Miles Hammersley instructed on behalf of the Claimant, and Professor Christina Doyle instructed in behalf of the Defendant. Both are Chartered Engineers. Mr Hammersley is a general forensic engineer, with a background in aerospace engineering, who has considerable experience in mechanical engineering, metallurgic and materials-based investigations. Professor Doyle has both commercial and academic experience, with particular experience and expertise in implanted medical devices and instruments.
The Regulatory Background
Medicinal products have been regulated in the United Kingdom since the Therapeutic Substances Act 1925; but the inadequacies of regulation became apparent in the early 1960s. The failings in respect of thalidomide led to demands for greater regulatory control, which was recognised in the United Kingdom in the Medicines Act 1968 and, later, in regulatory systems driven by European legislation. As a result, every aspect of the design, testing, promotion and marketing of medicines and medicinal products, including medical devices such as prosthetic components, is now closely regulated; and regulated on the basis of the precautionary principle. Broadly, the relevant regulatory authority, applying its own scientific and medical expertise, will only allow a product to be put (and, thereafter, maintained) on the market if it is satisfied that the product meets appropriate standards of safety, efficacy and quality.
For the purposes of this claim, it is unnecessary to bore deeply down into the regulatory scheme that applies to prosthetic components such as the C-Stem; but it will be helpful to describe the main planks of the scheme.
The Medicines and Healthcare products Regulatory Agency ("the MHRA") is the designated and competent authority in the UK for assessing whether manufacturers and their medical devices meet the relevant legislative requirements.
The C-Stem falls within the scope of the EC Council Directive 93/42/EEC ("the Medical Devices Directive"), as effectively implemented in the United Kingdom by the Medical Devices Regulations 2002 (SI 2002 No 618) ("the 2002 Regulations"), around which the regulatory scheme applying to the C-Stem is based. The scheme comprises the following strands, with which I will briefly deal in turn:
i) requirements for marketing approval (paragraphs 11–20 below);
ii) information requirements (paragraphs 21–22); and
iii) post-marketing surveillance obligations (paragraph 23).
By regulations 8 and 10 of the 2002 Regulations, a medical device cannot be marketed unless it meets the "Essential Requirements" set out in Annex I to the Medical Devices Directive, and has a CE (Conformité Européene) marking to that effect.
The General Requirements are set out in Part I of the Annex, and include, for example:
"1. The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety.
2. The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally accepted state of the art.
In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order:
• eliminate or reduce risks as far as possible (inherent safe design and construction).
• where appropriate take adequate protection measures including alarms, if necessary, in relation to risks that cannot be eliminated.
• inform users of the residual risks due to any shortcomings of the protection methods adopted."
This requirement therefore involves an assessment of whether the "risks" of the medical device are "acceptable". "Risk" in this sense is the hazard or chance of the happening of a particular adverse event that will cause loss or damage: the greater the potential loss or damage, the smaller will be the acceptable chance of it occurring. The assessment of risks posed by a medical device involves the compound assessment of the chance of each such potential adverse event; but the acceptability of those risks taken as a whole can only be seen in the context of the potential benefits that the device will bring. As the text of this requirement makes clear, whether a product has an acceptable level of safety therefore necessarily involves some balancing of risks and potential benefits including, of course, potential utility. Given that no medicinal product is free from risk, and thus "safety" in this field is inherently and necessarily a relative concept, a medical device will only be allowed onto the market if the product is assessed as having a positive risk-benefit ratio, in this sense. In this judgment, otherwise required, I shall use the term "risk-benefit" rather than "risk-utility", on the basis that, for these purposes, "benefit" includes "utility".
Risk-benefit in this context is explained in the commendable consideration of the issues surrounding "Product liability for medicinal products" in the chapter of that name by Charles Gibson QC, Geraint Webb QC and James Purnell in "Clinical Negligence" (Michael Powers QC and Anthony Barton eds, 5th Edition (2015), Chapter 13) ("Powers & Barton"), at paragraph 13.29, as follows:
"Underpinning the continuous process of review of medicinal products throughout their lifecycle, is the recognition that all medicines carry risks as well as provide benefits to the patients. No medicine is 100 per cent safe, and all medicines have side effects. A licence will only be granted or renewed if there is deemed to be a positive balance of risks and benefits (in other words, the benefits of the product outweigh the risks) or the product is, in the [MHRA's] own words, 'acceptably safe'. 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…."
That passage is focused upon pharmaceutical products; but it applies to all medicinal products, including medical devices such as prostheses. As Professor Doyle explained, any medical device necessarily involves design compromises which seek to reduce...
To continue reading
Request your trial
-
Ethicon Sarl v Gill
...Vale v Sutherland [2009] HCA 26; (2009) 237 CLR 638 Wallace v Kam [2013] HCA 19; (2013) 250 CLR 375 Wilkes v DePuy International Ltd [2016] EWHC 3096 (QB); [2017] 3 All ER 589 Wyong Shire Council v Shirt [1980] HCA 12; (1980) 146 CLR 40 Young PW, Declaratory Orders (2nd ed, Butterworths, 19......
-
Dineen v Depuy International Ltd
...of Public Works [2003] I.R. 521; [2003] 2 I.L.R.M. 252. Wilkes v. Depuy International Ltd [2016] EWHC 3096, [2018] Q.B. 627; [2018] 2 W.L.R. 531; [2017] 3 All E.R. 589. Tort — Personal injuries — Defective products — State of knowledge defence — Liability for defective products — State of s......
-
Hastings v Finsbury Orthopaedics Ltd and another
...and means of proof are matters for national law, subject to the principle of effectiveness. (See Wilkes v DePuy International Ltd [2016] EWHC 3096 (QB); [2018] QB 627, paras 66, 76, 96 per Hickinbottom J; Gee v DePuy International Ltd, The DePuy Pinnacle Metal on Metal Hip Litigation [201......
-
Sandra Bailey & Others v Glaxosmithkline (UK) Ltd
...the parameters for the forthcoming trial have not changed. Reference has been made to the recent decision of Hickinbottom J in Wilkes v Depuy International Limited [2016] EWHC 3096 (QB). Without, I trust, doing any injustice to his lengthy judgment, all he did in the section of his judgment......
-
Product Liability Comparative Guide
...to case law in other jurisdictions - for example: A v National Blood Authority [2001] 3 AER 289; Wilkes v DePuy International Limited [2016] EWHC 3096 (QB); European Commission v United Kingdom [1997] AER (EC) 48). There have since been various other reported Irish cases involving claims re......
-
Wilkes v DePuy (2016)
...1987 and confirms no requirement of absolute safety in all circumstances Mr Justice Hickinbottom's seminal decision in Wilkes v DePuy (2016) EWHC 3096 (QB) marks a substantial departure from Burton J's controversial approach to "defect" under section 3 of the Consumer Protection Act 1987 in......
-
Wilkes V Depuy (2016) QBD Departs From Previous Authorities On 'Defect' Claims Under The Consumer Protection Act 1987 And Confirms No Requirement Of Absolute Safety In All Circumstances
...Justice Hickinbottom's seminal decision in Wilkes v DePuy (2016) EWHC 3096 (QB) marks a substantial departure from Burton J's controversial approach to "defect" under section 3 of the Consumer Protection Act 1987 in A v National Blood Authority (2001) 3 All E.R. The decision provides clarit......
-
UK Supreme Court Rules On Whether A Product Is Defective
...similar claims, particularly following on from recalls or other corrective action, in the near future. Footnotes 1. [2022] UKSC 19 2. [2016] EWHC 3096 (QB) 3. [2018] EWHC 1208 (QB) The content of this article is intended to provide a general guide to the subject matter. Specialist advice sh......