United States: FDCA-Based California Case Preempted As Private Enforcement

Last Updated: August 1 2019
Article by James Beck

In a significant preemption decision clipping the wings of California consumer protection plaintiffs, two identical decisions: Borchenko v. L'Oreal USA, Inc., ___ F. Supp.3d ___, 2019 WL 3315288 (C.D. Cal. July 18, 2019), and Borchenko v. L'Oreal USA, Inc., 2019 WL 3315289 (C.D. Cal. July 18, 2019) (differing only by docket number, as far as we can tell), have held that preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), precludes all of the plaintiff's UCL claims. For simplicity, henceforth we'll only refer to the first, to-be-published, decision.

The claim in Borchenko richly deserved preemption, as it attempted to second-guess the classification of several FDA-regulated products. These products were all being marketed as "cosmetics" under the FDCA, but plaintiff claimed that they were really "skin structure altering drugs" that could not be sold unless the FDA approved new drug applications for them. 2019 WL 3315288, at *1. This was a classic " money for nothing" California-style strike suit, as "Plaintiff [took] no position on whether the skin structural representations are true or false." Id. Plaintiff was simply trying to second guess the FDA's classification of these products.

Under federal law, private plaintiffs cannot do this. "21 U.S.C. § 337(a) implicitly preempts any private right of action to enforce the FDCA, providing in relevant part, 'proceedings for the enforcement, or to restrain violations, of this Act shall be by and in the name of the United States.'" 2019 WL 3315288, at *2.

In order to escape preemption by the FDCA, "[t]he plaintiff must be suing for conduct that violates the FDCA . . ., but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman)."

Id. (quoting Perez v. Nidek Co., 711 F.3d 1109, 1120 (9th Cir. 2013)). Thus, Buckman prohibits state-law plaintiffs from seeking to relitigate the proper classification of products under the FDCA.

Plaintiff also claimed that, because "California's Sherman Law parallels the FDCA in material part and adopts all nonprescription drug regulations," she could evade Buckman's prohibition, because she was only bringing a state-law action. Borchenko, 2019 WL 3315288, at *2. The court blew away this largely transparent smokescreen. First:

The provisions of the Sherman Law cited by Plaintiff each rely on and essentially mirror parallel provisions of the FDCA.

Id. Second:

In addition to referencing the Sherman Law, Plaintiff relies heavily on FDA warning letters and informal guidance to argue that Defendant's products make "drug claims" and, therefore, must receive federal premarket approval.

Id. at *3. Third:

The fact that Plaintiff's claim is technically brought under the UCL and the Sherman Law does not override the fact that Plaintiff explicitly requests relief which lies squarely within the province of the FDA. There can be no state law cause of action if a plaintiff's true goal is to privately enforce alleged violations of the FDCA.

Id. (citations and quotation marks omitted). Indeed, since plaintiff sought to enjoin the defendant from selling its cosmetics until it received NDAs from the FDA, the suit's "true goal" was unmistakable. Id.

Further, by demanding withdrawal from the market, plaintiff was also trenching upon the FDA's discretionary enforcement authority:

Plaintiff's UCL claim interferes with the FDA's enforcement and regulatory authority as set out in §336 of the FDCA, which provides as follows: "Nothing in this Act shall be construed as requiring the [FDA] to report for prosecution . . ., minor violations of this Act whenever [it] believes that the public interest will be adequately served by a suitable written notice or warning." Plaintiff's claim, like any private cause of action to enforce the FDCA, conflicts with this explicit grant of discretionary authority.

2019 WL 3315288, at *3 (emphasis added). We used §336 as a one-two punch in combination with §337(a) back in the Bone Screw litigation before Buckman was decided. Borchenko demonstrates that it still has considerable appeal in the right case. We recommend that other defendants add it to their preemption armamentarium in appropriate cases.

Finally, California has become a food litigation hotbed because Farm Raised Salmon Cases, 175 P.3d 1170 (Cal. 2008), allowed the UCL-Sherman Act dodge of FDA enforcement exclusivity in food cases – but only because of a food-specific exception to the FDCA's prohibition on private enforcement – something we discussed here. Borchenko recognized that Farm Raised Salmon had no application to drugs (or alleged drugs). "[T]his Court is bound by Ninth Circuit precedent, including Perez, and not by Farm Raised Salmon or other California case law concerning preemption." 2019 WL 3315288, at *3. That's another nice holding, since other California courts occasionally need reminding.

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
 
In association with
Related Topics
 
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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