European Union: Product Liability For Medicines And Medical Devices In The European Union

Last Updated: 13 June 2016
Article by Wolfgang Rehmann and Diana Heimhalt

Across the European Union, medicines and medical devices are subject to the general product liability rules of the EU member states. An exception applies to Germany and, to a limited extent, to Spain and a few other jurisdictions, whose national laws provide for particularly strict liability regimes that specifically apply to medicines. Within the European Union, the general product liability laws are based on (i) a strict liability regime (without fault) under the national laws of the member states implementing the EU Product Liability Directive 85/374/EC ("the Directive"), and (ii) supplemental fault-based liability systems (negligence) under the national laws of torts of practically all EU member states. Both liability regimes apply in parallel. While it is generally easier for a claimant to establish a claim under the strict liability regime of the Directive, fault-based liability (negligence) continues to play a role in cases where a claimant seeks to recover damages beyond the limitations and liability caps that apply under the Directive (see below).

The strict product liability rules across all member states can nowadays be described as harmonized if not even as rather homogenous, in particular as the Directive does not allow for substantive deviations.

"Products" within the meaning of the Directive are "all movables even though incorporated into another moveable or into an immovable". This rather wide definition includes all finished goods as well as raw materials and components incorporated in a finished product. The product does not have to be a consumer product. Because of the wide scope of the definition, the standards established under the Directive apply to almost all medicines and medical devices. Yet, custom made drugs or devices do typically not fall within the scope of the Directive as the Directive only covers products that have been industrially produced.

Under the Directive, liability principally rests upon "the producer" of the defective product, component part or raw material. However, Article 3 of the Directive extends the definition of "the producer" to include:

  • any person who, by putting his/her name, trade mark or other distinguishing feature on the product, presents himself/herself as the producer;
  • any importer which has imported the defective product, component or raw material into the European Union market; and
  • any supplier (e.g. the retailer, distributor or a wholesaler) if the producer cannot be identified.

This broad definition of the "producer" seeks to ensure that, if the "producer" of the defective product (or a defective component part or raw material) is located outside the European Economic Area (EEA), an injured party will always be able to hold an EEA-based company responsible for his or her injury. The "producer" of the finished product and the "producer" of the defective component part or raw material can be held jointly and severally liable.

The strict liability regime imposed in the Directive sets out three core requirements for establishing liability on the part of the producer:

  • a product defect,
  • damage
  • and a causal link between these two.

To determine whether a product is defective a "reasonable safety expectation"-test applies under the Directive: A product is deemed to be defective if it does not provide the safety that consumers generally are entitled to expect taking all of the circumstances into account, including the presentation of the product, its use that could be reasonably expected and the time when the product was put into circulation (Article 6 of the Directive). In a decision of March 2015, the European Court of Justice has arguably significantly enlarged the concept of a "product defect" under the Directive with regard to implantable medical devices. The court held that a potential defect in pacemakers and implantable cardioverter defibrillators could lead to the conclusion that all devices of the same model/series are defective. In this case, the claimant only needs to prove that there was an increased number of device failures in the same batch or series and no longer needs to proof that the individual implant he or she had received suffered from a pertinent defect.

A product shall not be considered defective for the sole reason that a better (safer) product is subsequently put into circulation. This means that the defectiveness of a product is measured against an objective standard and it is irrelevant what level of safety the individual claimant expected. A key issue with medical devices is whether the way in which the product is presented, including the information and warnings given by the producer, provides consumers (and not only healthcare professionals) with adequate understanding of its inherent dangers.

The Directive applies to damages caused by death or by personal injuries. Liability is generally not capped. However, member states may set a limit for the total liability of a producer in the case of death or personal injury caused by identical items with the same defect. German law, for example, has set this total liability cap at 85 million EUR (higher caps apply with regard to drugs). Under the Directive, damage to property is only recoverable with regard to items of property other than the product itself, and to items intended for private use or consumption. The afore-mentioned limitations apply to claims under the strict liability regime of the Directive only. As the fault-based liability regimes under the respective national laws of torts apply in parallel, a claimant may seek to recover damages beyond these limitations under these fault-based liability regimes (negligence).

In general, the burden of proof is placed upon the injured party insofar as the damage, the defect and the causal relationship between the two is concerned (Article 4 of the Directive). The claimant needs to prove that the product is defective, that he or she has been injured and that there is a causal link between the defect and the injury.

The Directive contains a few defences which the producer can raise (Article 7 of the Directive). The burden of proof for these defences lies upon the producer. The producer may avoid liability if he can show that:

  • he did not put the product into circulation;
  • the circumstances of the respective case justify the assumption that the defect which caused the damage did not exist at the time when the product was put into circulation by the respective producer or that this defect came into being afterwards;
  • it did not manufacture the product for profit-making sale or any form of distribution with an economic intent;
  • the defect is due to compliance of the product with mandatory regulations issued by the public authorities;
  • the state of scientific and technical knowledge at the time when the respective producer put the product into circulation was not such as to enable the existence of the defect to be discovered ("state of the art"-defence); or
  • in the case of a manufacturer of a component part; that the defect is attributable to the design of the product in which the component has been fitted or to the instructions given by the producer of the product.

Furthermore, under both the Directive and in negligence the liability of the producer can be limited if the producer can prove that the consumer´s negligence caused or contributed to the damage.

Liability under the Directive will expire after three years starting from the date on which the claimant became aware or reasonably could have become aware of the damage and its cause, the defect and the identity of the producer. In addition, a long stop-halt applies: irrespective of knowledge or constructive knowledge, a producer´s liability expires ten years from the date on which the product was put in circulation (Article 10 of the Directive). Yet, again, different limitation periods can apply under the fault-based liability regimes of the laws of tort (negligence) of the Member States.

While the substantive product liability laws of all EU member states are largely harmonized under the EU Product Liability Directive, the national procedural laws and court practice of the members states which apply, among others, in product liability litigation can differ quite significantly. In particular, several features which may be considered as typical for U.S. litigation in this sector, do generally not exist in the European Union, e.g., outside the common law-jurisdictions (Ireland, and the UK) there is no pre-trial discovery, there are no jury trials, and no punitive damages are available. Also, there are no US-style class action procedures even if a few member states have recently introduced various other forms of collective consumer redress. Generally speaking, one can say that while European substantive product liability rules are largely similar to the substantive U.S. laws, the overall litigation risks of a producer are generally lower in most EU members states because of differences in the their procedural laws and practices.

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
 
In association with
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

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.

Emails

From time to time Mondaq may send you emails promoting Mondaq services including new services. You may opt out of receiving such emails by clicking below.

*** If you do not wish to receive any future announcements of services offered by Mondaq you may opt out by clicking here .

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.