United States: Guest Post – Design Defect Implied Preemption Is Not Just for Drugs

Last Updated: August 18 2017
Article by James Beck

Today's guest post is by long-time friend-of-the-blog, Dick Dean, of Tucker Ellis.  This post covers the preemption aspects of the recent (after remand from the Third Circuit) aviation decision in Sikkelee v. Avco.  If you're interested in this issue, we heartily commend the actual decision (which, we warn you, is quite lengthy), since in addition to its many significant legal rulings, it is studded with pungent language, mostly calling out and rejecting plaintiff's many off-the-wall arguments.  As always our guest poster deserves all the credit (and any blame) for the discussion that follows.

************

At times one can tell from the very first paragraph of an opinion that what follows will be an interesting read.  Such is the case with Sikkelee v. Avco Corp., Case. No. 4:07-CV-00886, 2017 WL 3317545(M.D. Pa. Aug. 3, 2017), a case involving the death of a pilot during a crash at take-off:

A weightless innocence so often attends our daydreams of flight. As the American aviator John Gillespie Magee, Jr., loftily described it, pilots "dance [ ] the skies on laughter-silvered wings," soaring "high in the sunlit silence."   Sadly, it would seem that Magee's "high untrespassed sanctity of space" must belong to a universe far away from the dark origins and convoluted history of this case.

Id. at *1. From this ephemeral beginning, we are soon transported to the detailed world of federal aviation regulations and their interaction with design defect and implied preemption.

This case is indeed "convoluted."  The crash occurred in 2005, and suit was filed in 2007, alleging different legal theories that distill to claims of a poorly designed carburetor.  There were two district court decisions (by two different district judges) dismissing plaintiff's state law torts claims on grounds of field preemption before the case reached the Third Circuit in 2015.  Field preemption occurs where the subject matter of the law suit is so occupied by the federal government that there is no room for state activity.  It is rarely invoked and hardly ever found. [ed. note: we know of only one FDCA field preemption decision]  The factual underpinnings of field preemption in the aviation field was best summarized in a concurring opinion of Justice Jackson in a tax dispute, quoted by the Sikkelee Court in its recent decision:

As the late Honorable Robert H. Jackson, Associate Justice of the Supreme Court, once remarked, "Planes do not wander about in the sky like vagrant clouds.  They move only by federal permission, subject to federal inspection, in the hands of federally certified personnel and under an intricate system of federal commands."  Northwest Airlines v. State of Minnesota, 322 U.S. 292, 303 (1944).  Justice Jackson's observation sprang from "the national responsibility for regulating air commerce" and reinforced the notion that the "air is too precious as an open highway to permit it to be owned" by local interests.  Id.  "Local exactions and barriers to free transit in the air would neutralize its indifference to space and its conquest of time."  Id.

Id. at *2.

Relying on the breadth of the Third Circuit's decision in Abdullah v. American Airlines, 181 F.3d 363 (3d Cir. 1999) (holding that federal law preempts the field of aviation safety in the context of federal in-flight seat belt regulations versus state law negligence claims), the Sikkelee Court found preemption first at 731 F. Supp.2d 429 (M.D. Pa. 2010) and most recently at 45 F. Supp. 3d 431 (M.D. Pa. 2014).  The Third Circuit reversed the later decision, finding that state law design claims were not covered by the decision in AbdullahSikkelee v. Precision Auotmotive Corp., 822 F.3d 680 (3d Cir. 2016).  But it is also observed that the claims might be barred by implied preemption—noting that the design changes advanced by plaintiff necessarily might have required FAA approval and thus would be barred under Pliva, Inc. v. Mensing, 564 U.S. 604 (2011) and Mutual Pharmaceutical Co. v. Bartlett, —U.S.—-, 133 S.Ct. 2466 (2013).  Indeed, it cited Mensing noting that where a party cannot "independently do under federal law what state law requires of it," the state law claim is preempted.  822 F.3d at 703.  It remanded for consideration of that issue. (See DDLaw April 22, 2016 post discussing the Third Circuit's suggestion that this claim might be conflict preempted).

On remand, the district court first examined the relevant FAA regulations noting "the FAA has littered the books with a maze of regulations not readily traversed by most laypersons."  2017 WL 3317545 at *2.  It observed that the first step in production of a new aircraft or aircraft engine is a "type certificate" confirming that the aircraft or its component is properly designed and manufactured.  Id. at *3.  It is an "onerous process requiring numerous submissions that precisely detail the specifications."  Id.  A type certificate holder may not independently change a type certificate's design details without first obtaining FAA approval.  Id. at *5-*6 (citing 14 C.F.R. §21.31).  The district court observed that the relevant test was whether federal regulations prevented the defendant from unilaterally doing what state law required, citing the Mensing test of independent action.  The court found that the alternate design theory advocated by plaintiff would have required approval by the FAA and was therefore conflict preempted.  It specifically cited the key language from Mensing establishing that the mere fact that defendant could have asked the agency to change its rules does not defeat preemption.

"To decide these cases," the PLIVA Court concluded, "it is enough to hold that when a party cannot satisfy its state duties without the Federal Government's special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for preemption purposes."  Id. at 623–24.  Justice Thomas then noted that in regulatory preemption cases such as these, "the possibility of possibility"—that is, the possibility that the agency will approve a requested change—does not defeat conflict preemption.  Id. at 624.

2017 WL 3317545 at *24. More colloquially, if you have to ask, it is preempted.

The Sikkelee Court also made two other points familiar to the readers of this blog.  First, it noted that impossibility conflict preemption may be found even in the absence of express preemption.  Id. at *22.  Second, it recognized that impossibility preemption requires no inquiry into congressional intent.  Id.  The only question is whether there is a conflict between state and federal law.

When Mensing was decided, the first argument of the plaintiffs' bar (and one that is still run today) was that it was limited to generics.  That was clearly wrong based on the "any party" language of Mensing.  Cases like Yates v. Ortho-McNeil-Janssen Pharmaceutical, Inc., 808 F.3d 281 (6th Cir. 2015) and In re Celexa and Lexapro Marketing and Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015), and many others [ed. note: see our preemption cheat sheet for the citations] have expanded the Mensing test to brand drug manufacturers' where regulatory approval was a predicate of the claim alleged.  Now the Mensing test has been appropriately applied to the federal aviation context.  With this decision, it can be said that Mensing applies generally—not just to generic drugs, or even just drugs at all.  In Mensing and Bartlett, "[c]onflict preemption did not turn on a drug maker's status as a brand-name or generic manufacturer per se."  Sikkelee, 2017 WL 3317545 at *31 n.26.  That is not a surprising conclusion, since this is how implied preemption is supposed to work, but it is nice to have this solid opinion building upon the Third Circuit's observations actually finding implied preemption in the aviation context.  Going forward, one needs to read any complaint involving relevant federal regulations with an eye on preemption: if the relief sought could not be undertaken unilaterally by the defendant in light of federal law or regulations the claim is preempted.

[Ed. note: we'd like to add one final point – about proximate cause. Sikkelee also recognized something we've observed about design changes too "minor" to require FDA pre-approval:  that such changes can't be causal in a product liability action. The same is true of "minor" design changes under the FAA:

If the alleged omission was a minor one, then by definition, it had no effect on the aircraft engine's structural strength, reliability, operational characteristics, or airworthiness. . . .  [T]he underlying claims are nothing more than state law tort actions, which require proximate causation.  If the alleged breach of duty had no appreciable effect on the engine's reliability, airworthiness, structure, or operation, then proximate cause cannot be met.

2017 WL 3317545 at *28 . Likewise, design changes too "minor" to affect a product's safety and effectiveness (the corresponding FDA standard), could not possibly be causal in a product liability action.]

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
James Beck
 
In association with
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.

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.