United States: No Causation, No Claim

Last Updated: January 6 2014
Article by Steven Boranian

Most Read Contributor in United States, October 2017

Today we feature a case that exemplifies two principles that we routinely encounter in our practices, but rarely at the same time. First, there is no more sympathetic plaintiff than a disabled military veteran. We come across and write on cases involving sad facts with some regularity, which is an occupational hazard of our practice in the drug and medical device arena. The most compelling cases we see involve patients who have experienced actual injuries, a fact that we always bear in mind as we report on what the law is and what we believe the law should be. Moreover, while everyone has a point of view on what kinds of cases provoke the greatest sympathy, we have learned in our many years on Reed Smith's Pro Bono Committee that disabled veterans garner the broadest imaginable support. Some people champion children's issues; others promote immigration reform, or perhaps they favor housing rights. But everyone gets behind programs supporting disabled veterans. And rightfully so. Today's veterans are young men and women who have completed their service and have their whole lives ahead of them, often with significant challenges.

The second principle that today's case brings to mind is that civil litigation cannot and should not provide a remedy if the law and facts are not there to support one, no matter how sympathetic the plaintiff may be. The district court's order granting summary judgment in Carnes v. Eli Lilly& Co., No. 0:13-591-CMC, 2013 U.S. Dist. LEXIS 176201 (D.S.C. Dec. 16, 2013), brings together these two principles by presenting a disabled Army veteran and physicians who prescribed prescription drugs with full knowledge of all the relevant risks. In Carnes, the plaintiff injured his spinal cord while attempting to rescue fellow soldiers in Iraq, and as a result he is wheelchair bound, has significant physical limitations, and suffers from chronic pain. Id. at *1. One physician prescribed Lyrica, an antiepileptic drug indicated for treating pain associated with spinal cord injury, but after about three years on the drug, the plaintiff asked to stop. Id. at *2. The doctor therefore prescribed Cymbalta, which is a serotonin and norepinephrine reuptake inhibitor that is also indicated for treatment of chronic pain. After a few months, the plaintiff changed doctors and asked to switch his medication again because he thought the drug was causing him to gain weight. Id. at *2. The new doctor therefore tapered the plaintiff off Cymbalta and restarted Lyrica. Id. at **2-3. According to the doctor, she tapered the plaintiff's dose "to avoid potential side effects from stopping Cymbalta suddenly." Id. at *3.

As the second doctor's remarks suggest, discontinuing Cymbalta can result in withdrawal-like symptoms, which the doctor knew about and which the product's label disclosed at all relevant times. Id. at **4-5. The physician who first prescribed the drug similarly was aware of the risk of withdrawal symptoms "having learned about them in medical school, during his residency, and from patients who experienced withdrawal symptoms." Id. at *16. Alas, the plaintiff experienced post-discontinuation symptoms that he attributed to the drug, including sharp headaches, nightmares, anger, and shaking. He therefore sued the drug's manufacturer, who moved for summary judgment under South Carolina's learned intermediary doctrine.

The district court's order granting summary judgment is useful on multiple levels. To start, the court observed that "[p]rescription drugs are neither defective nor unreasonably dangerous if accompanied by proper direction and warnings," which reiterates to us that South Carolina applies comment k across the board to all prescription drug cases. Id. at *9. In addition, the court confirmed that South Carolina applies the learned intermediary doctrine in prescription drug cases and that "a plaintiff must not only show that the drug manufacturer's warning was inadequate, but 'also that the inadequacy of the warning was the proximate cause of the plaintiff's injury.'" Id. at *10. Lots of courts have made statements like this under various states' laws, and our readers will find the statement a familiar truth. This court, however, went a helpful step further and explained exactly what warnings causation means, i.e., that different or additional information would have changed the physician's prescribing decision. As the court put it,

In light of the learned intermediary doctrine, 'the burden remains on the plaintiff to demonstrate that the additional non-disclosed risk was sufficiently high that it would have changed the treating physician's decision to prescribe the product for the plaintiff.'"

Id at *10. This is not an extraordinary holding, but it is reassuring to see a court lay out the rule so clearly and completely. We have often said that warnings causation is a powerful element because it forecloses liability for failure to warn in the abstract. Maybe the labeling could reasonably have been stronger or more complete in some conceivable way. Or maybe it could not have. We have no reason to believe that the warnings at issue in Carnes were in any way less than adequate, but either way, we do know that the court asked the correct question: Would additional warnings have made any difference for this actual plaintiff vis-à-vis his physician's decision to prescribe the drug?

This court clearly understood the law and properly placed the burden on the plaintiff. With regard to the doctor who initially prescribed the drug, the plaintiff argued that certain study results should have been disclosed in the label, but the doctor "testified that had he been provided the warning Plaintiffs allege would have been adequate, he still would have prescribed." Id. at *14. There is no more clear break in the causal chain than this, particularly where the plaintiff has set forth specific information that the alternate "adequate" label allegedly should have included. We think every plaintiff claiming inadequate warnings should have to set forth a proposed alternative, but many get away with leveling only vague criticisms.

Nor was the plaintiff able to salvage his warnings-based claims by taking the doctor out of the equation. The plaintiff argued that he as a patient would not have taken the drug if he personally had known about the risk of withdrawal, thus attempting "[w]ithout any legal authority . . . to displace the learned intermediary doctrine." Id. at *14. But the court correctly ruled that the law "requires the court to focus on the physician's decision to prescribe the drug." Id. at *15 (emphasis added). With regard to the doctor who tapered the plaintiff off Cymbalta, she too testified that even if the label had included information that the plaintiff said should have been there, she still would have gradually reduced his dose, just as she did when she made her actual treating decisions. Id. at *21. Case closed.

The court's disciplined order is all the more admirable because it was filed nine days before Christmas, a time of year when the sympathy toward a disabled war hero might have been heightened. However, in light of the evidence as the court described it, this is the correct result based on correct reasoning, and the court's very clear restatement and application of the learned intermediary doctrine is a good example to file away for future use.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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
Related Video
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.