United States: No Duty To Report To FDA In North Carolina, No "Parallel" Claim

Last Updated: June 13 2019
Article by Steven Boranian

We take every chance we can get to drive nails into the coffin of the Ninth Circuit's spectacularly wrong opinion in Stengel v. Medtronic. That's the case where the court held that federal law did not preempt negligence claims alleging that the defendant medical device manufacturer failed adequately to report adverse events to the FDA. Of course, the Arizona Supreme Court later held that the Ninth Circuit was dead wrong: There is no such duty to report under Arizona law, making this so-called "parallel claim" no claim at all, which we reported here.

A recent order from the Eastern District of North Carolina has further exposed Stengel as the fraud that it was, and, in the process, the district court presented a particularly clear-minded application of express and implied preemption in the medical device context. If you ever wondered about our references to the "narrow gap" between express and implied preemption, then this is the order for you. It explains it all exceptionally well and comes to the correct result.

The case is McNeil-Williams v. DePuy Orthopaedics, No. 5:18-cv-220, 2019 WL 2179217 (E.D.N.C. May 20, 2019), and the facts are straightforward: The plaintiff was treated with the defendant's prosthetic knee device and later sued claiming that the device caused her pain. Id. at *1. Because the FDA approved the device through the rigorous Premarket Approval process, the manufacturer justifiably moved for summary judgment on the basis that federal law preempted the plaintiff's claims—both expressly and impliedly. Id. at *2.

As faithful readers know, the analysis begins with the Medical Device Amendments of 1976 ("MDA") and the Supreme Court's opinion in Reigel v. Medtronic, 552 U.S. 312 (2008). The following quotes are kind of long, but if you read them, you will know all you need to know to discuss express and implied preemption at most any cocktail party (provided you frequent parties attended by drug and medical device lawyers):

Against [the] backdrop of rigorous premarket approval, the MDA preempts state law claims in two respects. First, the MDA expressly preempts any state law "requirement . . . which is different from, or in addition to, any requirement applicable under [the MDA] to the device." The United States Supreme Court has interpreted this provision to mean that "common-law causes of action for negligence and strict liability. . . impose 'requirements' and would be pre-empted by federal requirements . . . ." Reigel, 552 U.S. at 323-24. Accordingly, "[s]tate requirements are pre-empted under the MDA only to the extent that they are different from, or in addition to the requirements imposed by federal law."

Second, the MDA "impliedly" preempts additional types of state law claims. Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 347 (2001). . . . [S]tate law claims not arising from "traditional state tort law which . . . predated the federal enactments in question . . . , but rather "solely from the violation of [MDA] requirements, " are impliedly preempted because "Congress intended that the MDA be enforced exclusively by the Federal Government."

McNeil-Williams, at *3 (citing Reigel and Buckman, emphasis added). This is where the "narrow gap" comes in: A plaintiff's state-law claims have to allege conduct that violates federal law, but the conduct also must violate a separate and independent state requirement. In other words,

[T]hese two types of preemption, operating in tandem, have created . . . a "narrow gap" for pleadings in a medical device products liability case. . . . To make it through, a plaintiff has to sue for conduct that violates a federal requirement (avoid express preemption), but cannot sue only because the conduct violated that federal requirement (avoiding implied preemption).

Id. at *4 (quoting Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1327 (11th Cir. 2017)). So the trick for plaintiffs is to allege a breach of a state-law duty that mimics (or "parallels") a federal requirement, and that is where the district court in McNeil-Williams got it so right and the Ninth Circuit in Stengel got it so wrong.

The plaintiff in McNeil-Williams attempted to plead a "parallel" claim by alleging (like the plaintiff in Stengel) that the defendant failed adequately to report adverse events to the FDA. The problem for the plaintiff is that there is no such duty to report under North Carolina law. See Our prior post on state law reporting-based claims, here. Thus, the plaintiff was suing only for violations of federal requirements, a claim which was clearly preempted:

Plaintiff's primary asserted theory of negligence liability fails, however, because North Carolina law does not recognize a parallel duty on manufacturers to report to the FDA as plaintiff asserts. Rather, North Carolina law recognizes a duty to warn only users or medical practitioners in certain circumstances.

. . . .

Plaintiff cites no case, and the court has found none, where North Carolina courts have recognized a duty under North Carolina law to inform the FDA of adverse reactions, defects, and other injury information.

Id. at *4. Does this sound familiar? It should, because it is on this precise basis that the Arizona Supreme Court skewered the Ninth Circuit's treatment of Arizona law in Stengel. As the district judge explained, "Notably, after Stengel, the Arizona Supreme Court expressly disavowed the reasoning of Stengel on the very proposition that is at issue in this case." Id. at *5 (citing Conklin v. Medtronic, Inc., 431 P.3d 571 (Ariz. 2018)).

No duty to report under North Carolina law means no "parallel" claim (of course, that also means no claim under state law, either). The plaintiff's claims were therefore preempted.

The plaintiff attempted to recast her claims as "duty to warranty" claims, but she could not explain how that duty was different from a garden variety duty to warn. Nor could she identify any warranties that ran parallel to federal requirements. McNeil-Williams, at *5. The plaintiff also asked for discovery, but the district court rejected that too because the "court's preemption determination herein turns upon the simple undisputed fact that the Product is a medical device granted premarket approval by the FDA." Id., at *6. The plaintiff could not describe discovery that would provide a basis to dispute that fact.

In the end, the discovery ruling might be the most uniquely valuable part of this order. We have seen the "narrow gap" applied correctly before, but plaintiffs will continue to try to keep cases alive, including by conducting time-consuming, but ultimately useless discovery. This district court saw through that, and correctly so.

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
Similar Articles
Relevancy Powered by MondaqAI
Hughes Hubbard & Reed LLP
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Hughes Hubbard & Reed LLP
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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