United States: "Stengel" Tangles MDA Preemption: Ninth Circuit Decision Creates Split On "Buckman" Preemption Of Post-Market Reporting Requirements

Last Updated: January 22 2013
Article by Erin M. Bosman, Joanna Simon and Julie Y. Park

Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: "failure to warn the FDA." The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S. 365 (9th Cir. 2013), delivered by Judge Fletcher, held that the Medical Device Amendments ("MDA") to the Food, Drug, and Cosmetic Act ("FDCA") did not preempt this claim because it parallels a federal-law duty imposed by the MDA. This new cause of action opens the door, at least in the Ninth Circuit, to claims against all medical device and drug manufacturers, and could defeat Mensing preemption of failure to warn claims against generic drug manufacturers.


In October 2000, Richard Stengel had a SynchroMed EL Pump and Catheter—manufactured by Medtronic—surgically implanted in his abdomen to deliver pain relief medication directly into his spine. In February 2005, Mr. Stengel collapsed, reporting heaviness and decreased sensation in his right leg. At the hospital, Mr. Stengel was diagnosed with ascending paralysis. The device was removed, but Mr. Stengel became a paraplegic. Mr. Stengel claimed the device caused his paralysis.

Plaintiffs alleged that Medtronic became aware of risks associated with the pain pump before Mr. Stengel was paralyzed in 2005, but it did not inform the FDA of the risks. The FDA discovered the risks—and that Medtronic knew about them—more than a year after Mr. Stengel's injury. In July 2007, the FDA sent a warning letter to Medtronic stating that Medtronic "misbranded" its pain pump by concealing known risks. In January 2008, Medtronic sent a Medical Device Correction Letter and in March 2008, it recalled the device.

Mr. Stengel and his wife sued Medtronic, alleging that it violated a state-law duty of care by failing to report the known risks associated with the pain pump to the FDA.


Congress enacted the MDA to extend coverage of the FDCA to medical devices. The MDA divides medical devices into three classes according to user risk. Class III devices are those deemed by the FDA to have the highest risk—they are those that "cannot be determined to provide a reasonable assurance of safety and effectiveness under Class I or II controls and are marketed either as life-supporting or possibly causing an unreasonable risk of illness or injury." Class III devices are subject to the pre-market approval ("PMA") process of the FDA. 21 U.S.C. § 360c(a)(1)(C).

During the pre-market approval process, the FDA performs a risk-benefit assessment and determines the adequacy of the manufacturer's label. The FDA can then approve the application, deny it, or approve it with conditions on distribution. Notably, the MDA contains an express preemption clause, which provides that no state may establish any requirement "which is different from, or in addition to, any requirement applicable" under the MDA. 21 U.S.C. § 360k(a). Under the Supreme Court's decision in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), many courts have found that state-law claims concerning PMA devices are preempted.

After the FDA approves a medical device (Class I, II, or III), the MDA imposes a duty on the manufacturer to report any information that reasonably suggests that the device (1) may have caused or contributed to a death or serious injury or (2) has malfunctioned and that any recurring malfunction would be likely to cause or contribute to a death or serious injury. 21 C.F.R. § 803.50(a); 21 U.S.C. § 360i(a). It is this reporting duty that formed the basis of the Stengels' state-law "failure to warn the FDA" claim.


The district court dismissed the Stengels' complaint and denied leave to amend, holding that the MDA preempted all of the Stengels' claims, including the negligence claim based on Medtronic's failure to report known risks of the pain pump to the FDA. Stengel v. Medtronic, No. CV 10-318-TUC-RCC, 2010 WL 4483970, at *3-4 (D. Ariz. Nov. 9, 2010). The Stengels appealed and the Ninth Circuit affirmed. 676 F.3d 1159 (9th Cir. 2012). The Ninth Circuit granted re-hearing en banc.


The en banc panel framed the issue as "whether the MDA preempts a state-law claim in which the state-law duty of care 'parallels' a federal-law duty imposed by the MDA." In other words, the court asked, do the MDA's federal reporting requirements preempt state-law claims based on a medical device manufacturer's duty to report known risks to the FDA? The answer: a resounding "no."

The Ninth Circuit started with the usual "presumption against preemption." The court then considered the three Supreme Court MDA preemption cases: Medtronic Inc. v. Lohr, 518 U.S. 470 (1996); Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001); and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008). The Ninth Circuit found support for its conclusion in all three cases.

First, the court noted that, in Lohr, the Supreme Court found Florida could impose a state-law duty to warn patients and physicians regarding the risks of a particular pacemaker, despite parallel federal warning requirements under the MDA. The Stengels alleged a similar concurrent duty—violation of the MDA's post-marketing reporting requirements.

With regards to Buckman, the Ninth Circuit noted that plaintiffs there—unlike the Stengels—alleged no state-law claims, and instead "were concerned exclusively with alleged fraud on the FDA that had occurred as part of th[e] [pre-market] approval process." Because the Stengels did not allege fraud during the pre-market approval process, their state-law claims were not preempted under Buckman. The Ninth Circuit's rationale contradicts years of jurisprudence finding that all claims alleging violation of disclosure requirements to the FDA are preempted. See, e.g., Marsh v. Genentech, Inc., 693 F.3d 546 (6th Cir. 2012) (under Buckman, courts should not determine adequacy of post-marketing disclosures to FDA); In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig., 623 F.3d 1200 (8th Cir. 2010) (Buckman preempts allegation that defendant "failed to provide the FDA with sufficient information and did not timely file adverse event reports, as required by federal regulations").

Finally, concerning Riegel, the Ninth Circuit found that contrary to the Stengels' allegations, the state-law duty alleged by the plaintiffs there directly conflicted with, as opposed to paralleled, the federal duty set forth under the MDA. Therefore, Riegel was easily reconciled with the Ninth Circuit's present holding. In fact, the Ninth Circuit's decision creates an end-run around Riegel, which held that similar failure-to-warn claims for PMA devices were preempted by the MDA. 552 U.S. at 329.

The court found further support in other circuit court opinions, noting "[o]ur sister circuits have uniformly held that, in cases dealing with violations of the MDA outside the pre-market approval process, the MDA does not preempt state-law causes of action for damages in which the state-law duty 'parallels' the federal-law duty under the MDA." See Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011); Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) cert denied 132 S. Ct. 498 (2011).

These authorities bolstered the court's holding that the Stengels' state-law negligence claim based on Medtronic's failure to report known risks to the FDA was not preempted "insofar as the state-law duty parallels a federal law duty under the MDA." Judge Watford further emphasized this point in his concurrence, noting that "the Stengels' negligence claim is not expressly preempted because it seeks to hold Medtronic accountable only for failing to do what federal law mandated—nothing more. The state law duty, as alleged by the Stengels, is precisely parallel to the duties imposed by federal law."

Judge Watford also noted that the Stengels, who framed their claim "as they must to avoid express preemption," will likely face a "causation hurdle" as their case progresses. He noted, "[t]o prevail, they will ultimately have to prove that if Medtronic had properly reported the adverse events to the FDA as required under federal law, that information would have reached Mr. Stengel's doctors in time to prevent his injuries."


Under Stengel, the MDA preemption analysis will turn on whether the state-law duty at issue parallels the MDA-imposed federal duty or conflicts with the MDA-imposed federal duty. Manufacturers should be prepared—this decision effectively allows plaintiffs to bring state-law negligence claims premised on federal standards, so long as the plaintiffs frame the state-law duties as mirroring or "parallel to" those of the MDA. Even though the Buckman court rejected the notion that "any violation of the FDCA will support a state-law claim," Stengel suggests otherwise for cases in the Ninth Circuit. The broad reach of this newly created "failure to warn the FDA" claim should not be underestimated—particularly for its potential to breathe new life into claims against generic drug manufacturers. The decision will likely aid plaintiffs in overcoming motions to dismiss and may result in manufacturers being flooded with a wave of failure to warn the FDA-type cases.

Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Morrison & Foerster LLP. All rights reserved

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.

Erin M. Bosman
Joanna Simon
Julie Y. Park
In association with
Related Video
Up-coming Events Search
Font Size:
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
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
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.


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.


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.


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.


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.


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.


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 .


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.