United States: Checking Out The B-Side

Last Updated: September 22 2017
Article by Michelle Yeary

Search for Medtronic on this blog and you're going to find preemption cases. Lots of preemption cases. Mostly preemption victories for the defense. An overwhelming body of preemption law has been made by Medtronic. They've certainly led the charge. So, if we say today's post is a Medtronic case about a spinal implant, you're likely thinking more preemption. While that wouldn't be a bad thing, even here at the DDL blog we can get a little tired of beating the preemption drum (don't let Bexis know). Everyone once and a while we like to sing a different tune.

After all, if you never flipped over to the B-side, you may have missed some really good music. We'll now pause to explain B-sides to the iPod generation who may be completely unfamiliar with the old 45-rpm single. The single was meant to showcase an album's prospective hit on its A-side with an additional song on the B-side. The B-sides were typically throw away tracks. But sometimes, an equally good, and some may argue better, song could be found by flipping the single over. For example, 'I Am the Walrus' was on the B-side of the Beatles 'Hello Goodbye' (that was a John v. Paul thing). Pearl Jam's 'Yellow Ledbetter' was the B-side of 'Jeremy' until radio DJs made it a hit on its own. U2 originally only released 'The Sweetest Thing' as the B-side to 'Where the Streets Have No Name.' And, perhaps one of the best songs of all time (says this blogger and Sir Paul McCartney) – 'God Only Knows' was a B-side. To be fair it was the B-side to the Beach Boys 'Wouldn't It Be Nice?' so isn't that really like two A-sides?

In the case we're bringing you today, Medtronic had previously won a motion to dismiss plaintiff's fraud and consumer protection claims on the grounds of preemption (among other reasons). See our post here. So, you've already heard the A-side. But following that decision, plaintiff's design defect and manufacturing defect claims under the Louisiana Products Liability Act (LPLA) remained. So Medtronic moved for summary judgement. As to design defect, plaintiff had to concede that it had no evidence of an alternative design, so that claim was dismissed with prejudice. See Lyles v. Medtronic Sofamor Danek, USA, 2016 U.S. Dist. LEXIS 38550, at *15 (W.D.La. Mar. 23, 2016). On manufacturing defect, plaintiff alleged res ipsa loquitur — welcome to the B-side of this record. The district court granted summary judgment. See id. at *21-23. Plaintiff appealed. But the Fifth Circuit said the district court got it right. Like the Stones got it right with 'You Can't Always Get What You Want' on the flip side of 'Honky Tonk Women'.

Plaintiff had multiple medical device components implanted in his spine to treat his spinal stenosis and cervical cord compression. Lyles v. Medtronic Sofamor Danek, USA, 2017 U.S. App. LEXIS 17534, at *3 (5th Cir. Sept. 11, 2017). X-rays taken within the first day of surgery showed something amiss with one of the implanted plates (experts disagree regarding whether the plate was broken or just misaligned). Id. at *3-4. Plaintiff sought additional treatment and underwent a second surgery, but the plate was not explanted and remains in plaintiff's spine. Id. at *4-5.

To maintain a manufacturing defect claim under the LPLA, plaintiff has to prove that at the time the medical device left the manufacturer's control, it materially deviated from its specifications or from other identical products from the same manufacturer. Id. at *9. Plaintiff offered no proof of either the device's specifications or how the device used in his surgery deviated from those specifications. He relied instead on res ipsa loquitur – arguing that the only reasonable inference that would explain the device breaking was that there was a defect in how it was made. Id. at *10.

The Fifth Circuit does a nice job of explaining both how the doctrine is to be applied sparingly and then discussing those rare situations in which a plaintiff has been allowed and not allowed to use it in the products liability context. See id. at *10-13. In sum, "where there are other potential causes of injury, a plaintiff's inability to exclude all known potential causes other than a manufacturing defect preclude his reliance on the doctrine." Id. at *13.

In his opposition to defendant's motion for summary judgment, plaintiff relied exclusively on two things – the short time between implant and breakage and his expert's conclusion that he had no other reason for the breakage other than a defect. Id. at *13-15. What plaintiff failed to do was address any of the "multiple potential explanations," offered by the defendant. Id. at *14. Putting aside for a minute that plaintiff can't make an argument on appeal that he didn't make below, his new argument to the Fifth Circuit was that there was no evidence for defendant's alternative explanations. But plaintiff lost sight of his burden of proof:

[T]o succeed on the theory of res ipsa loquitur, [plaintiff] has the burden of producing evidence excluding other reasonable explanations. Though [plaintiff] argues that there is no evidence for any other cause for the [device's] breakage, there is no evidence for a manufacturing defect either, which is why he is invoking res ipsa loquitur. The other reasonable explanations for the [device's] breakage posited by [defendant] are equally as likely as a manufacturing defect. It is [plaintiff] who has the burden to adduce evidence excluding them.

Id. at *15-16. The issue isn't whether there is evidence to support the other reasonable explanations, but rather what evidence plaintiff has adduced to exclude the other reasonable explanations. Id. at *18.

Further, plaintiff didn't offer any evidence that any alleged defect existed when the device left the manufacturer's control. Prior to plaintiff's surgery, the device was stored at the hospital and any number of people had access to it. Id. at *16-17. The Fifth Circuit concluded that even if the district court had been wrong in not applying res ipsa loquitur, which it wasn't, plaintiff's manufacturing defect failed on this ground as well. Id. at *17.

Res ipsa loquitur is definitely a B-side to preemption but don't overlook the B-sides or you might miss out on a winner.

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 Topics
 
Related Articles
 
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
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