The recent furore over the rupture of breast implants containing regulatorily unapproved clinically untested industrial grade silicone has understandably raised serious questions about the adequacy of the European regulatory legislation of products for cosmetic surgery.
Here, we review the relevant European legislation on medical devices. This note will not review the current status of the clinical and toxicological issues with these implants, suffice it to say that women implanted with these prostheses manufactured by the French company PIP are now very concerned that rupture and release into breast tissue of potentially toxic silicone may cause cancer. Although there is no evidence as yet of any long term harm from such rupture and tissue deposition, there is insufficient knowledge of the long term safety of this industrial grade product. It therefore remains to be seen with litigation under consumer protection and/ or the general consumer safety legislation will be successful.
Medical Devices Regulatory Legislation
The onus of satisfying conformity to the essential legal requirements of safety and fitness for purpose of a medical device lies with the producer, subject in most cases to the approval an independent 'notified body'. The manufacturer must apply an appropriate conformity assessment procedure and complete a declaration of conformity. The choice of conformity assessment procedure depends on a risk based classification either on a total quality management system audited to ISO 9000 series as customised for medical devices with EN4600 series standard, or individual product assessment.
The essential requirements relate to the safety of the device, including labelling requirements expressed in terms of scientific and technical performance characteristics. This should include evaluation of clinical data but not necessarily in terms of efficacy. Also manufacturers have post marketing safety surveillance and vigilance requirements. In parallel, Member States have market surveillance obligations. The national regulatory authority has the power to effect the withdrawal of the product in its jurisdiction and the matter is then referred to the Commission for coordination with other Member states.
Medical devices are defined as:
any instrument, apparatus, appliance or other article, whether used alone or in combination, including the software necessary for its proper application by the manufacturer, to be used for human beings for the purpose of
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- investigation, replacement or modification of the anatomy or of a physiological process...
Marketing of medical devices in the EU is governed by three principal Directives: Directive 90/385/EEC on active implantable medical devices, Directive 93/42/EEC on medical devices, and Directive 98/79/EEC on in vitro diagnostics.
All these Directives were implemented into UK law as from 13 June 2002 by the Medical Devices Regulations 20021. The basic structure, concepts and terminology are identical across all three. Ultimate authority for their interpretation rests with the Court of Justice of the European Community, to which questions of interpretation of Community law may be referred by national courts.
There are also a sequence of guidance notes issued by the Commission (MEDDEV series) arising out of meetings with notified bodies, etc.
Member State competent authorities, whilst not involved in the assessment or authorisation for placing on the market, do have the responsibility to oversee the competence and performance of notified bodies within their jurisdiction. However the legal responsibility for safety, fitness for purpose and general product liability and duties under the general product safety legislation rests with the manufacturer.
Medical devices are categorised on the basis of the potential degree of risk they represent. Class IIa and IIb are invasive or implantable devices or those which do interact with the body; whereas Class III is for devices which affect the function of vital organs. Breast implants, in common with devices such as contact lenses, urinary catheters, dental bridges and crowns, would be classified as Class II.
For all products in Class II a full quality assurance system, audited periodically by a notified body including examination and certification of the design dossier of each product, must be carried out.
As regards legal liability, a manufacturer is defined as a natural or legal person with the responsibility for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name, regardless of whether these operations were carried out by himself or on his behalf by a third party2. The Regulations require a manufacturer to observe the manufacturers obligations set out in the relevant conformity procedure and to take account of the results of any assessment or verification operations carried out at an intermediate stage of manufacture3.
Product liability under the Consumer Protection Act 1987
The main legislation dealing with liability of producers for defective products is the Consumer Protection Act 1987 (the CPA). Part 1 of the CPA implements EC Directive 85/374 on Liability for Defective Products. The introductory wording of the CPA and European Court of Justice jurisprudence4 make it clear that where there are textual differences between the CPA and the Directive, the Directive should prevail and the CPA should be interpreted in light of the purpose of the Directive. Furthermore, the ECJ has held that a producer's liability for defective products must be identical throughout EC member states.
The CPA confers strict liability on the "producer" of a defective product for damage caused by the defect5. Any claim brought under this Act would be brought by the consumer of the product, who must demonstrate that the product is defective and that the defect caused the damage.
The burden of proof is on the claimant. The legal test that the Court will apply is the "but for" and "balance of probabilities" test, i.e. but for the use of the product, the claimant's actual damage would not have occurred on the balance of probabilities.
Damages awards in the UK are not intended to be punitive. The claimant must prove the loss he has suffered and will be awarded damages to compensate him for this loss. In addition the CPA excludes claims not exceeding Ł2756. The CPA defines damage as "death or personal injuries or any loss of or damage to any property (including land)"7. Whilst the CPA appears to exclude pure economic loss, e.g. loss of earnings, the Directive does not. Given that the CPA needs to be interpreted in light of the Directive, the scope for damages is, therefore, exceedingly broad.
The limitation period for bringing a claim under the CPA is three years from the later of (a) the cause of the personal injury by the defective product or (b) the date of knowledge of the defect by the claimant. The Court has discretion to exclude this limitation period with respect to personal injury cases only8. There is also a long-stop limitation period under the CPA and Directive9, stating that the rights conferred upon the injured person will be extinguished if an action is not brought within 10 years of the date on which the producer put the product into circulation.
Liability will not attach if the defect came into existence after the product left the defendant. However products with latent defects are defective as at the date of supply.
A producer has a defence if it proves that the state of the scientific and technical knowledge at the time when it put the product into circulation was not such as to enable the defect to be discovered.
The scope of this defence has been circumscribed in the UK by the decision of A v National Blood Authority10 and, under the principles laid out in that judgment, it would be difficult to prove one fell within this defence. Certainly once the existence of a defect is known and there is a risk that it will materialise in any product, it is immaterial that the known risk was unavoidable in the defective product.
It appears then that the current status of liability for defective breast implants would lie primarily with the manufacturer who put the product(s) into circulation; the notified body responsible for issuing the CE mark and the national competent authority would not engage liability under the consumer protection legislation. However both organisations could be held liable in negligence.
1 SI 2002/618. Part 1 deals with introductory measures common to all devices, general medical devices Part II, active implantable devices Part III,in vitro diagnostics Part IV, notified bodies, conformity assessment bodies and marking of products Part V, fees Part VI and general and enforcement measures Part VII.
2 Directive (EEC) 93/42, Art 1.2 (f); the Regulations, reg 2 (1)
3 The Regulations, reg 17 (2)
4 Case C-300/95 Commission v UK
5 section 2(1) CPA
6 section 5(4) CPA
7 section 5(1) CPA
8 s33 Limitation Act 1980
9 Art 11 Directive
10  EWHC QB 446 (26th March 2001)
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.