Austria: "Failure To Warn" In Pharmaceutical Product Liability Cases

Last Updated: 19 November 2018
Article by Katrin Hanschitz
Most Popular Article in Austria, November 2018

Recent case law from the Austrian Supreme Court has helped clarify the role of the prescribing physician in pharmaceutical product liability cases.

In the absence of clear guidance from the European Court of Justice , there has been some uncertainty in Austria – and in many EU Member States – on whether, in pharmaceutical product liability cases turning on "failure to warn", the information and warnings supplied directly to health care professionals are to be taken into account.

In its ruling of 18 February 2018 (10 Ob 8/18a ) the Austrian Supreme Court confirmed a decision of the Higher Regional Court of Vienna which clarified that, with prescription-only medication, the task of assessing the risks, deciding on the suitability of this (type of) medication and warning the patient about side effects, fall primarily upon the physician. The court viewed the manufacturer's package information leaflet as additional information provided to the patient at a later date, following the obligatory, critical, information provided by the prescribing physician.

Background

In Austria, as is generally the case among EU Member States, the EU Product Liability Directive 85/374/EEC extends to cover pharmaceutical product liability. Defects that may give rise to product liability are manufacturing defects, design defects and failure to warn.

In view of the rigorous testing and benefit-risk analysis in the course of the drug approval process and the extremely strict manufacturing regimes in play, drugs are considered to be less likely to show manufacturing and design defects than other products.

Pharmaceutical product liability cases, instead, often tend to turn on whether the patients were sufficiently informed about the risks of side effects, once causality has been established.

For prescription-only drugs, scrutiny of two types of product information can be applied:

  1. the summary of product characteristics, which contains information for the prescribing physician, and
  2. the package information leaflet, i.e. the information leaflet contained in the packaging for the pharmaceutical product that is directed at the patient.

Despite several important medical product liability rulings of the European Court of Justice in recent years, uncertainty remains as to whether the information and warnings given to physicians are to be taken into account by the court, as well as the information supplied directly to consumers.

Interestingly, in Austrian product liability cases regarding prescription-only drugs, judges in courts of first instance tend to focus exclusively on the information given to the patient in the package information leaflet. Far less attention is paid to the contents of the summary of product characteristics and the behavior of the prescribing physician. This may be because the prescribing doctors are rarely directly involved in such cases; they may be called as witnesses but are rarely named as co-defendants. Another reason for this may well be the lack of pertinent legal literature and case law covering the interrelationship between warnings provided to consumers and product information provided to the physicians prescribing the drugs.

New Case Law

Recent case law of the Higher Regional Court of Vienna (5 R 129/17b) takes a closer look at how and in what way patients purchasing prescription-only drugs receive warnings on potential side effects:

In one such case, the claimant suffered a thrombosis, a known side-effect of the combined hormone contraceptive ("anti-baby pill") she was using. She argued that she had been insufficiently warned in the package information leaflet, where the risk had been trivialized and was, moreover, not comprehensible to a lay person.

The court did not find claimant's arguments persuasive: It held that because the contraceptive was prescription-only, the task of assessing the risks, deciding on the suitability of this (type of) contraceptive and warning the patient about side effects fell primarily to the physician. The court found that, after examining the client, taking the medical history and assessing the medical risks, the physician is required to discuss the risks with the patient. The court viewed the producer's package information leaflet, on the other hand, as supplemental information provided to the patient at a later date, following the critical information the patient must be given and explained by the prescribing physician. In the case at hand, the court determined that the information provided in the package information leaflet was sufficient to absolve the producer from liability.

Following this line of argument, the question of how clearly and – to a lay person – understandably these complex medical risks must be set out in the package information leaflet should be of secondary relevance, since the patient must already have been alerted to the pertinent risks in the course of the consultation with the prescribing doctor.

The Supreme Court (10 Ob 8/18a) upheld the appellate court's ruling but did not take the opportunity to consider this line of argument. Implicit in its ruling, however, is that for prescription-only drugs patients who have already received the benefit of a consultation with their physician on the risks of side effects only a briefer, if "realistic" and sufficiently emphatical warning is required, commensurate with the gravity of the potential side effect.

A more thorough and edited version of the article is anticipated to appear in the ABA 2018 Year in Review.

https://www.linkedin.com/company/knoetzl/

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 Topics
 
Related Articles
 
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Sign Up
Gain free access to lawyers expertise from more than 250 countries.
 
Email Address
Company Name
Password
Confirm Password
Position
Industry
Mondaq Newsalert
Select Topics
Select Regions
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

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 or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq 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 of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions