United States: A Banner Week For Buckman Preemption

Last Updated: September 2 2016
Article by James Beck

There used to be a TV show called "That Was the Week That Was." It was a satirical look at the news of the prior week, but perhaps it's most lasting accomplishment was to launch David Frost's career. Without an ounce of satire, however, we have to say that the business week of August 15 through 19, 2016 was a heck of a week for implied preemption utilizing Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). We've already blogged about the Ninth Circuit's decision in DeBons v. Globus Medical, Inc., ___ F. Appx. ___, 2016 WL 4363171 (9th Cir. Aug. 16, 2016), which invoked Buckman preemption to affirm dismissal of a consumer protection class action that was seeking to recover based on allegations that a medical device wasn't properly "approved" (but rather cleared under §510(k)) by the FDA.

But DeBons was only one part of that week's Buckman hat trick.

On the same day, the Fifth Circuit got into the act, affirming a preemption-based dismissal of another medical device product liability suit in Estes v. Lanx, Inc., ___ F. Appx. ___, 2016 WL 4375644 (5th Cir. Aug. 16, 2016). We've already blogged about favorable district court results in the Estes case three times. The Fifth Circuit affirmed all of them. Estes involved a spinal fixation system anchored with bone screws, some of which broke under the intense pressures of holding the human body upright. The screws were explanted and replaced, but "neither the hospital nor [defendant] retained" them. Id. at *1.

Plaintiff first screamed "spoliation" – he lost. Id. ("we find no basis for disturbing the district court's finding of no bad faith").

Unable to establish a conventional defect without the product, plaintiff tried "fraudulent concealment" instead. That's where his claim collided with Buckman. The alleged "fraud" involved how the defendant allegedly presented the device to the FDA:

[Plaintiff's] claim for fraudulent concealment was premised on the allegation that by submitting component-based applications (rather than a single application) for 510(k) approval for the [device] system, [defendant] violated the Federal Food, Drug, and Cosmetic Act ("FDCA").

Estes, 2016 WL 4375644, at *2. Buckman, of course, famously held that there can't be a private right of action for enforcing FDCA violations, and this claim plainly failed the Buckman preemption test because it could not exist without the FDCA – since there wouldn't have been an FDA application process at all unless statute existed. Id. (plaintiff's "claim is based on the allegation that the system lacked, to use his words, 'the requisite FDA approval'"; thus, it 'exist[s] solely by virtue of the FDCA disclosure requirements'") (citation and quotation marks omitted).

Our non-preemption Estes post praised a discovery ruling that refused to require production of documents about other devices that the defendant made that were never prescribed for, or used by, the plaintiff. The Fifth Circuit affirmed that as well:

[Plaintiff] also sought all consumer complaints for any [a different] device. . . . To the extent this discovery would even matter with the dismissal of the fraudulent concealment claim that we have just affirmed, we conclude that the trial court did not abuse its discretion in denying the discovery request.

Id.

Two days later, Elliott v. Sandoz, Inc., 2016 WL 4398407 (N.D. Ala. Aug. 18, 2016), completed the week's Buckman Trifecta. Elliott involved a generic drug, so the plaintiff's immediate problem was to gin up some sort of claim that stood a prayer of getting around Mensing/Bartlett preemption. This particular drug was approved only as a "last resort" for patients suffering from a life-threatening condition. However, since the physician prescribed it off-label for a non-life-threatening condition, plaintiff made off-label promotion allegations against the both the defendant and the manufacturer of the branded reference drug (not a defendant). 2016 WL 4398407, at *2.

Plaintiff also alleged that the defendant (indeed, any seller of this drug) had to supply pharmacies with FDA-mandated "Medication Guidelines," which were in turn supposed to be given directly to patients by pharmacies. Id. Plaintiff claimed that the defendant didn't supply enough of these guides, the decedent (this was a wrongful death case) never received it, and wouldn't have taken the drug if he had, because of the off-label use issue – that is, that the decedent would not have followed his doctor's prescription. Id.

These allegations in Elliott formed the basis for warning and fraudulent marketing claims. Also included throughout the complaint were vague allegations that the defendant failed to warn "physicians" generally about the risks of off-label use. No go. Buckman, combined with TwIqbal, did them in.

First, Buckman. Plaintiff was trying for the hypothetical "parallel claim" exception to generic drug preemption, alluded to in Bartlett, footnote 4 (we discussed that in more detail here). Plaintiff argued that the medication-guide-based claims were "parallel" claims – alleging conduct violative both of state and federal law − and thus were not preempted.

Fail!

In her attempt to run away from Mensing/Bartlett, plaintiff ran headlong into Buckman.

The court finds the argument in favor of preemption is persuasive. Plaintiff seeks to sue Defendant for an alleged violation of federal law and regulations − that is, Defendant's failure to provide the Medication Guide. The duty of Defendant to provide Medication Guides to pharmacies . . . arises solely under federal law. See 21 C.F.R. §208.24(b). Even if Mensing and its progeny do not apply in this case (which is doubtful because Plaintiff is ultimately arguing a "failure to communicate" theory . . .), Plaintiff's claim that Defendant was negligent for failing to provide Medication Guides to Decedent is preempted by section 337(a).

2016 WL 4398407, at *6 (other citations and quotations omitted). Section 337(a), of course, is the foundation of Buckman preemption. "The Supreme Court has held that 'that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions." Id. at *5 (quoting Buckman, 531 U.S. at 349 n.4 (which, in turn, cites §337(a)).

Nor could plaintiff point to any analogous state-law duty. A medication guide goes to the plaintiff-patient. The learned intermediary rule (adopted in Alabama, like everywhere else) bars warning claims based on direct-to-patient allegations. Id. at *6-7 ("the manufacturer has no further duty to warn the patient directly") (citation and quotation marks omitted) (emphasis original). TwIqbal then nailed plaintiff's "conclusory statement" that the defendant failed to warn "physicians." Id. at *7.

Nor did plaintiff's warning claims plausibly allege causation. Employing judicial notice, the court observed that multiple companies manufactured this generic drug, id., and the prescribing physician could have relied on any (or indeed, none) of their warnings. Id. ("any one of the [manufacturers] may (or may not) have influenced or warned [the prescriber] (adequately or inadequately) concerning off-label use of [the drug]"). Finally, since plaintiff couldn't plead enough to satisfy TwIqbal, she certainly couldn't plead fraud-based claims with the specificity needed to satisfy Fed. R. Civ. P. 9(b). Id. at *8 (allegations were "quintessential examples of the 'naked assertion[s] devoid of further enhancement'") (citation omitted).

That makes three nifty Buckman-based wins – two of them appellate – in one week. Keep up the good work.

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
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.

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.