United States: The Preemption Pendulum: The Supreme Court Punts Stengel V. Medtronic

Last Updated: June 25 2014
Article by Michael A. Walsh

Drug and Medical Device Manufacturers Beware; State-law Parallel Claims Threaten

As failure-to-warn claims, the decades-old staple of medical products liability, are relegated to the trash bin of tort jurisprudence, a new and more potent approach—parallel claims—has emerged. What are parallel claims, where did they come from, why did they emerge, and when will the Supreme Court clear up the issue?

With the advent of mass tort litigation for claims involving Food and Drug Administration (FDA) approved products in the 1980's, the defensive doctrine of federal preemption emerged in fits and starts and, since the mid 1990's, has gradually swung the pendulum toward dismissal of claims, relegating claimants to those few venues where jurists, flummoxed by the lack of a remedy, forged a tenuous path forward. Whether Congress has intentionally refused, or simply neglected to provide a private remedy for tort claimants is unclear. What is increasingly clear is that trial courts are finding room in Supreme Court rulings to permit state-law tort claims to proceed. Claimants are also finding a willing advocate in the FDA itself, which has flip-flopped from its prior view favoring preemption to its position that now assists private litigants in pursuing private tort and Lanham Act "labeling" claims under the Food Drug and Cosmetic Act (FDCA).

Parallel Claims: What Are They And Where Did They Come From?

A triumvirate of Supreme Court cases forms the foundation for federal preemption and parallel claims for medical devices under the FDCA (See Medtronic, Inc. v. Lohr,518 U.S.470 (1996), Buckman v. Plaintiffs' Legal Comm.,531 U.S. 341 (2001)and Reigel v. Medtronic, Inc.,552 U.S. 312 (2008)). These opinions gave birth to another trio of Supreme Court cases addressing preemption in the context of approved drugs (See Wyeth v. Levine, 555 U.S. 555 (2009), Pliva v. Mensing, 131 S. Ct. 2567 (2011)and Mut. Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013)).

In Lohr, the Supreme Court stated that the FDCA does not preempt "a traditional damages remedy for violations of common-law duties when those duties parallel federal requirements." Lohr, 518 U.S. at 495. Buckman purports to allow tort claims where the plaintiff is "relying on traditional state tort law" but not where the FDCA "is a critical element in their case." Buckman, 531 U.S. at 353. In Riegel, the Court established a two-prong test for determining if a state-law tort claim could proceed: 1) has the FDA established applicable "requirements"; and 2) does state law create a requirement related to safety or effectiveness that is "different from or in addition to the federal requirement." Reigel, 552 U.S. at 322. While the precise contour of purported "parallel claims" is uncertain, no court allows claims that seek to impose liability despite compliance with the applicable FDCA.

Something Odd in the (5th, 7th and 9th) Circuits: Out of the shadows of these Supreme Court opinions, a trilogy of Circuit Court opinions have arisen that threaten to up-end medical products liability. See Bausch v. Stryker Corp., 630 F.2d 546 (7th Cir. 2010), Hughes v. Boston Scientific, 631 F.3d 762 (5th Cir. 2011), and Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. en banc 2013), cert. denied (U.S. June 23, 2014) (No. 12-1351). In Bausch v. Stryker Corp., the Seventh Circuit noted:

The idea that Congress would have granted civil immunity to medical device manufacturers for their violations of federal law that hurt patients is, to say the least, counter-intuitive. That protection does not apply where the patient can prove that she was hurt by the manufacturer's violation of federal law.

Bausch, 630 F.2d at 549. This claim's permissive sentiment is echoed in Hughes v. Boston Scientific Corp., where the Fifth Circuit stated that Riegel and Lohr "make clear" that a manufacturer is not protected from state tort liability when the claim is based on the manufacturer's violation of applicable federal requirements. Hughes, 631 F.3d at 765. The court in Hughes further observed: "[w]e are persuaded that any additional 'formal' finding or enforcement action by the FDA is not an 'implicit precondition' to suit under the facts of this case.") Id. at 762.

The Supreme Court and Stengel: With Stengel v. Medtronic, a significant stepchild was poised to join the triumvirate of Supreme Court cases that gave birth to parallel claims. In Stengel, the Ninth Circuit reinstated purported state-law failure-to-warn claims, stating that the "[Medical Device] Amendments do not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty." Citing Lohr the Court stated:

Given the ambiguities in the statute and the scope of the preclusion that would occur otherwise, we cannot accept [the manufacturer's] argument that by using the term 'requirement,' Congress clearly signaled its intent to deprive the States of any role in protecting consumers from the dangers inherent in many medical devices.

Lohr, 518 U.S. at 489. The government filed an amicus brief in the Supreme Court asserting that all the Circuit Courts are wrong concerning parallel claims yet arguing for denial of certiorari. The government's newly minted view is:

Section 360k(a) does not preempt respondents' straightforward claim that petitioner should have brought new safety information to physicians' attention through a CBE revision to the device's labeling, because such a claim implicates no preemptive device-specific federal requirement.

On June 23, 2014 the Supreme Court denied certiorari in Stengel leaving intact the Ninth Circuit's reversal of the District Court decision denying plaintiffs' motion to assert a parallel state-law failure-to-warn claim. With the denial of cert by the Supreme Court, the case is remanded to the district court to determine whether the plaintiffs should be permitted to further amend their complaint in light of the Ninth Circuit's opinion.

Further feeding the fire of private claims under the FDCA, private tort claimants have a peculiar bedfellow in three curious Lanham Act cases brought by manufacturers asserting claims that parallel the FDCA. See Allergan et al. v Athena, No. 2013-1286, 2013 U.S. App. LEXIS 25746 (Fed. Cir. Dec. 30, 2013); POM v. Coca Cola, 2014 U.S. Lexis 4165 (2014), and GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., 2:13-CV-00726 –ER (ED PA Mar. 2014).

In a curious juxtaposition, the government's newly minted support of private litigation under the FDCA allows ample room for state law to meddle, yet the same government retains a possessive hand on its own power to regulate. With the Supreme Court tied in knots over if, why, when and how to reign in the ever expansive Fourth Branch of government (See generally Chevron v. Natural Resources Defense Council, 467 U.S. 837 (1987), Decker v. Northwest Envtl. Def. Ctr., 2013 LEXIS 2373 (2013), Christopher v. SKB2012 U.S. LEXIS 4657 (2012) and Util. Air Regulatory Group v. EPA, 2014 U.S. LEXIS 4377 (2014), perhaps the only issue more confounding than preemption is the deference to be given governmental agencies in the first instance.

Manufacturers of FDA regulated products have enjoyed a decade of generally favorable rulings on the issue of federal preemption and deference to the primacy of FDA jurisdiction limiting or dismissing claims, but the political climate, the courts' emerging approaches and the government are reshaping the litigation landscape. While it is unclear if or when the Supreme Court will rule on the diverging views in the Circuits on state-law parallel claims, it is evident that tort claimants will look to the Ninth Circuit opinion in Stengel as the talisman for their medical products liability claims.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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
Michael A. Walsh
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Related Articles
 
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
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