United States: California Court Incorrectly Nips And Tucks At Implied Preemption

Last Updated: August 29 2018
Article by Steven Boranian

We understand that we write a lot about federal preemption. You might even be rolling your eyes at yet another post on this most powerful of defenses, but we just can't help ourselves. Federal regulation runs deep in the drug and medical device world, and the possibility that federal law might preempt state-law claims is an ever-present possibility. To be sure, there is no shortage of litigation alleging that drug and device companies have violated state law duties, so we don't want to overstate matters. Regardless, federal preemption remains the bright shiny object from which we cannot avert our gaze.

Federal preemption demands our attention also because it is so often misunderstood and/or misapplied. We have said at times that some judges are hostile to preemption, and that might be true for some of the obviously result-oriented opinions that we review. It is more likely that courts confront the many branches of preemption and the spider web of cases applying preemption in its various flavors, and they just get it wrong. God only knows that the authorities are not always clear.

This is a long lead-in to a recent case that got preemption wrong on so many levels that we're not completely sure what to make of it. In Tryan v. Ulthera, Inc., No. 2:17-cv-02036, 2018 U.S. Dist. LEXIS 140111 (E.D. Cal. Aug. 17, 2018), the plaintiffs sued the manufacturer of a medical device that uses ultrasound to tighten skin and reduce wrinkles on the face, neck, and chest. The FDA cleared the device for marketing through the 510(k) premarket notification process, which is different from the more rigorous premarket approval (or "PMA") process that some other devices go through. The plaintiffs' beef was that the manufacturer represented that the device was "FDA approved" (as opposed to "FDA cleared") in violation of FDA regulations. Id. at **2-4.

The case seems fairly straightforward. Plaintiffs based their claims on an alleged violation of the Food Drug & Cosmetic Act ("FDCA") and its regulations. Moreover, the plaintiffs did not allege any complication with their procedures, or even that the device did not work exactly as it was supposed to. Instead, they alleged that had they known the device was not FDA approved, and that it was merely FDA cleared, they would have paid less for the therapy or considered alternative treatments. Id. at *4.

Whatever you think of those allegations and the likelihood that any consumer would draw any distinction between "FDA cleared" and "FDA approved," these plaintiffs were suing because of a violation of the FDCA, which runs directly into implied preemption under Buckman and 28 U.S.C. § 337(a). Whether the device was FDA "approved," "cleared," or whatever, without the FDCA, there would be no FDA action at all. Buckman is the Supreme Court case that held that state-law claims conflicting with the FDCA are impliedly preempted, and Section 337 mandates that only the federal government can enforce the FDCA. Whenever a purported state-law cause of action includes as a "critical" element some sort of FDCA violation, it runs afoul of § 337(a) and is therefore impliedly preempted under Buckman. Buckman involved a 510(k) device, so device categories do not affect implied preemption.

The manufacturer therefore justifiable moved to dismiss on implied preemption, and in denying the motion, the district court got off on the wrong foot, and it got worse from there. The district court began its discussion with the express preemption clause of the Medical Device Amendments, which expressly preempts any state law requirement which is "different from or in addition to" federal requirements. Id. at *10. This is a valid legal principle as far as it goes, but it is completely irrelevant to this case: The defendant did not assert that federal law expressly preempted the plaintiffs' claims. The defendant asserted implied preemption, under which federal law preempts state law where the state law conflicts with federal law or stands as an obstacle.

You might ask what difference that would make? Well, it makes a big difference, because in its next breath, the district court invoked the questionable and often-misunderstood "parallel claim" exception to preemption. As the "exception" goes, because the MDA's express preemption clause preempts state-law requirements that are "different from or in addition to" federal requirements, claims based on state-law duties that "parallel" federal requirements are not preempted.

We can debate whether the "parallel claim" exception is a good idea or whether federal authorities actually support its existence. One thing, however, is certain:

There is no parallel claim exception to implied preemption.

The district court's introduction of express preemption at the outset of its opinion was therefore no harmless error. It started the opinion down a legal path from which the opinion would never recover, as the court forced the plaintiffs' allegations into an "exception" that does not exist. For example, the district court noted with approval that the plaintiffs alleged that California law "incorporates and mirrors the FDCA." Id. at *11. In the context of implied preemption, that observation alone should have been the death knell of this case because it acknowledged in plain terms that the plaintiffs were suing to enforce the FDCA. We know from Buckman and section 337(a) that such actions are not allowed. The "mirroring" of California law matters only in food cases, to which a statutory exception to section 337(a) applies. That exception does not apply to medical devices (or drugs), which we detailed here.

Unfortunately, the district court misapprehended this point again and again. It noted the "linkage" between state and federal law and cited the plaintiffs' use of federal "regulatory and statutory violations" as the predicates for their state-law claims. Id. The court noted that California statutes adopt federal regulations as state-law standards. Id. The court observed that California law prohibits false and misleading advertising. And why is it misleading to say a Class II medical device cleared through the premarket notification process is "FDA approved"? Because such a statement allegedly violates federal regulations. All paths lead back to the plaintiffs suing to enforce the FDCA, which is the epitome of implied preemption.

The district court also wrongly cited federal law in support of its opinion. It relied on Medtronic Inc. v. Lohr, 518 U.S. 470 (1996), to describe the FDA's 510(k) process. Id. at **5-6. The court certainly is not alone in citing Lohr on this point, but as we have explained here and here, Lohr understates and marginalizes the 510(k) process' focus on safety and efficacy and was outdated even before it was published. The district court also stated that "FDCA regulations appear to directly preclude preemption," but once again the cited regulation defines the scope of the Medical Device Amendment's express preemption provision. That provision did not apply, nor did the defendants argue that it should. Id. at *13.

Finally, the court observed that 510(k) clearance does not preempt "state statutes of general application." Id. at **13-14. Of course the mere fact of 510(k) clearance does not create a blanket of preemption over "statutes of general application," and we highly doubt the defendant argued that it did. However, when the plaintiffs is claiming that a medical device manufacturer violation a state statute of any kind because its conduct violated the FDCA, that's implied preemption, and that is exactly what the plaintiffs alleged here.

In the end, we have a class action alleging that "FDA approved" and "FDA cleared" are different enough to consumers that the law should require awarding damages to patients who allege no injury and for whom the device may have worked exactly as advertised. We are not so sure, nor are we sure that this order will survive an appeal.

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
 
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