Contrary to some assertions in the media, the issues surrounding PIP implants are not straightforward. There seems to be a strong case that those who, pursuant to a patient contract, used PIP implants in breast enhancement surgery may be liable under domestic laws. However, in the absence of voluntary action, it is only likely to be litigation which clarifies the position. This article considers some of the relevant legal issues.
The French firm Poly Implant Prothese (PIP) manufactured and supplied silicone breast implants worldwide. Since 2000 more than 300,000 PIP implants have been sold in 65 countries and approximately 40,000 women in Great Britain have been treated using the implants, mainly for breast augmentation. Private clinics / hospitals performed 95% of the related operations; the remainder were carried out by the National Health Service. The French authorities have confirmed recently that PIP implants made before 2001 may contain industrial silicone. This means that an estimated 7000 additional women who were treated using PIP implants prior to 2001 may also be affected.
A problem arises because, as is now well known, the implants contain industrial rather than medical grade silicone. In addition it has been alleged that the implants were not treated with a protective coating to minimise the risk of rupture and the leakage of their contents into the surrounding tissue.
Following the recall of the implants by the French medical regulatory authority, PIP went into liquidation.
The rupture rate of PIP implants is a matter of controversy. The French authorities state that it is 5%. The UK's Medicines and Healthcare Products Regulatory Agency (MHRA) claim that the rate is 1%. Other bodies claim other rates.
The issue, for patients and their legal advisers is, however, a more pressing one of what is to be done and who is to pay. In the UK the Health Secretary has stated that the NHS will remove and replace implants inserted into women by the NHS and remove, but not replace, implants fitted privately if the company concerned is unwilling to do so itself. So for patients treated privately who, if anyone, is legally responsible for the predicament in which they now find themselves?
Breast argumentation surgery is a works and materials contract and is governed by The Supply of Goods and Services Act 1982 (SGSA), which requires goods supplied under such contracts to be of satisfactory quality (SGSA section 2). This requirement will be met if the goods supplied comply with the standards "that a reasonable person would regard as satisfactory taking account of any description of the goods, the price (if relevant) and all other relevant circumstances." (SGSA section 2A).
The question of the safety of the products supplied under the contract is relevant both to the SGSA and to the Medical Devices Directive (93/42 / EEC) pursuant to which specific attention must be given to whether the product is potentially toxic and whether steps have been taken to reduce to a minimum the health dangers that could arise from leakage from them. If such steps have not been taken then the related product could be argued to be potentially unsafe with the consequence that its sale would be unlawful.
In relation to the question of whether a product is not of satisfactory quality a claimant would need to show:
- that a reasonable person would consider it to be of unsatisfactory quality, ie (in respect of the PIP implants) would a person who knows that PIP implants contained non-medical grade products risk them being used as part of their medical treatment; and
- that the claimant relied upon the defendant's skill and judgment in choosing which product to use from all of those available.
The SGSA gives the consumer (the patient in this case) the right to require the repair and replacement of the goods in question (SGSA section 11M(2)(a)). This right would be unavailable only if repair or replacement would be impossible or the cost disproportionate (SGSA section 11N(3)).
There would seem little likelihood in relation to PIP implants of a court accepting that repair or replacement would be disproportionate. The SGSA provides that the cost would be disproportionate only if it was unreasonable taking into account either the "value which the goods would have" if they had conformed to the contract or if any other (cheaper) remedy "could be effected without significant inconvenience" to the patient (SGSA section 11(4)).
In addition, recent authority (Weber v Wittmer  3 CMLR) has confirmed that the objective of the Directive is to give consumers a high level of protection and, where the remedy of repair or replacement is available, the supplier may not refuse "the only remedy which allows the goods to be brought into conformity with the contract".
The remedies referred to above will be exercisable against the person with whom the patient had entered into the contract for the supply of goods and services.
Usually this will be with the medical institution which either performed or (if different) arranged for the treatment to be carried out. In some cases the claim may be made against the surgeon who performed the surgery, if that person had both a separate contract with the patient and sole judgment as to the choice of prosthesis to be used.
In some cases where the patient had an exclusive contract with a third party who then sub-contracted to purchase theatre facilities and nursing care from a hospital or clinic and surgical skills from a surgeon it is likely that only the third party contractor could be claimed against since in such circumstances the patient is unlikely to have had a contract with the sub-contractors. Much will, however, depend upon the precise facts and in particular whether either of the other two parties played a material role in choosing the prosthesis used in the surgery. A party which has not participated in the choice of the implants or their insertion is unlikely to be in breach of a contract to supply goods required to comply with domestic and European Safety Standards even if that party has made theatre space and nursing care available to assist the surgery to take place.
A negligence claim can be an alternative, as it is not necessary for there to be a contractual link between the parties to the action: one need only show that the defendant owed the claimant a duty of care, and such duty has been breached. For instance a surgeon would certainly owe a duty of care to the patient, even without a contract between them. However it would not be easy to prove a breach of that duty where the act complained of is the selection of a product licensed for use throughout the European Union.
It has been suggested that hospitals or clinics who are found to have infringed the SGSA will be able to sue the organisation which supplied the defective product to them even if they are unable to sue the ultimate manufacturer, PIP, which has gone into liquidation.
This seems unlikely as the Product Liability Directive (85/374/EEC) states that primary liability rests with the producer (or producers) of a product. If the producer cannot be identified liability might attach to the supplier of the product but only if the supplier fails to notify the injured person within a reasonable time of the identity of the producer or of the person who supplied him with the product. Liability for defective products does not transfer to a supplier merely because the producer has gone into liquidation. Attempts to extend producer's liability for defective products to participators in the supply chain has been resisted by the European Court of Justice (see Case C-302/03 Skov  ECR 1-223 and more recently Case 495/10 Centre Hospitalier Universsitaire de Besancon (Grand Chamber 21 December 2011)).
The Secretary of State for Health has suggested that all hospitals / clinics which have used PIP products in breast enhancement treatment have a "moral responsibility" to remove and replace them. Moral responsibilities are not contractually enforceable but even this obligation has a legal context.
Several clinics have not only denied having a moral responsibility but have suggested that if anyone does have such a responsibility it is the government for allowing defective products to be licensed for use in the UK for almost ten years. Having lawfully utilised a product permitted for use by the regulator and being faced with costs of repair and replacement which could destroy their business, some hospitals/clinics have stated that if they are not required by law to take such steps they will not be driven to it by a moral obligation they do not recognise.
With action against the manufacturer probably futile, the most likely means of redress for an affected patient is a claim against the person with whom she had the contract for her treatment. Who this is will vary from case to case, and will not necessarily be the hospital where the procedure was carried out or the surgeon who performed it.
We note that a group action involving more than fifty law firms on behalf of the 40,000 women who received PIP implants is currently being organised which will have, as one of its aims, the clarification of the issues discussed in this article.