UK: The PIP Scandal – The Legal Context

Last Updated: 24 April 2012
Article by Ian Adamson

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.

Background

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?

Domestic Law

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 [2011] 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 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.

Defective Goods

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 [2006] ECR 1-223 and more recently Case 495/10 Centre Hospitalier Universsitaire de Besancon (Grand Chamber 21 December 2011)).

Moral Responsibility

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.

Conclusion

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.

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.

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
 
Some comments from our readers…
“The articles are extremely timely and highly applicable”
“I often find critical information not available elsewhere”
“As in-house counsel, Mondaq’s service is of great value”

Related Video
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert
Email Address
Company Name
Password
Confirm Password
Mondaq Topics -- Select your Interests
Accounting and Audit
Anti-trust/Competition Law
Consumer Protection
Corporate/Commercial Law
Criminal Law
Employment and HR
Energy and Natural Resources
Environment
Family and Matrimonial
Finance and Banking
Food, Drugs, Healthcare, Life Sciences
Government, Public Sector
Immigration
Insolvency/Bankruptcy, Re-structuring
Insurance
Intellectual Property
International Law
Law Practice Management
Litigation, Mediation & Arbitration
Media, Telecoms, IT, Entertainment
Privacy
Real Estate and Construction
Strategy
Tax
Transport
Wealth Management
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these terms & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.