United States: U.S. Supreme Court Rules Judges Must Decide Whether Preemption Applies, And Clarifies When It Does

Last Updated: June 12 2019
Article by Hogan Lovells

On 20 May the U.S. Supreme Court unanimously ruled that federal preemption questions arising under the Federal Food, Drug, and Cosmetic Act (FD&C Act) are for a judge, not a jury, to decide. In doing so, the court reversed a March 2017 Third Circuit decision that had revived product liability litigation regarding Fosamax and remanded the case to that court for reconsideration. The opinion in Merck Sharpe & Dohme v. Albrecht addresses drugmakers' preemption defense to state law failure-to-warn claims. Since the Supreme Court's 2009 decision in Wyeth v. Levine, a defendant is not liable for alleged inadequate warnings if there was "clear evidence" that the U.S. Food and Drug Administration (FDA) would not have approved a labeling change to address the inadequacy. Per Albrecht, whether that defense is viable is the province of the judge. 

The Albrecht decision seems likely to benefit drug company defendants in two ways. One is procedural: because the decision is the province of the judge, the issue can be addressed in motions, perhaps leading to earlier resolution. The other is in avoiding the unpredictability of a jury decision on what is often a central issue in drug product failure-to-warn cases. At the same time, the decision might be seen as narrowing the circumstances under which the preemption defense will apply. The Albrecht decision says the "clear evidence" that FDA would not have approved the necessary labeling change must show that FDA was "fully informed" of an asserted need for the warning and rejected a proposed labeling change to address it.

The court decides viability of preemption defense  Writing for the majority, Justice Breyer offered four reasons why the preemption question is primarily an issue of law for a judge to decide without a jury:

  • The question "often involves the use of legal skills to determine whether agency disapproval fits facts that are not in dispute."
  • Judges are better equipped "to evaluate the nature and scope of an agency's determination" because they are experienced in "[t]he construction of written instruments," such as those normally produced by a federal agency to memorialize its considered judgments, pursuant to Markman v. Westview Instruments, Inc.
  • Judges are better suited than juries to understand and interpret agency decisions in light of the governing statutory and regulatory context, as they are familiar with principles of administrative law.
  • Courts may have to resolve subsidiary factual disputes "that are part and parcel of the broader legal question," pursuant to Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc.

Heading back to the Third Circuit, this case will now turn on the judges' determination on whether there is "clear evidence" that FDA would have rejected the subject warning.

"Clear evidence" of preemption narrowly defined

In Wyeth, the Supreme Court ruled that people injured by a drug product may file state failureto-warn suits against drug manufacturers, even though the drugs involved and their labels (which include warnings) had been approved by FDA. This weakened, but did not obliterate, the preemption defense, which was still available to a defendant who could provide "clear evidence" FDA would have rejected the additional warning that a plaintiff says was necessary. Albrecht puts a finer point on what constitutes such "clear evidence," clarifying that a drug manufacturer must show that it "fully informed the FDA of the justifications for the warning" and the agency "informed the drug manufacturer that the FDA would not approve changing the drug's label to include that warning."

The Albrecht decision defines "clear evidence" of preemption not "in terms of evidentiary standards, such as 'preponderance of the evidence' or 'clear and convincing evidence' and so forth," but "as a matter of law for the judge to decide." The court explained: "the judge must simply ask himself or herself whether the relevant federal and state laws 'irreconcilably conflic[t].'"

Implications for drug manufacturers

After the 2017 Third Circuit decision, we wrote that the "clear evidence" standard set by Wyeth might be impossible to meet, absent a "smoking gun" letter from FDA rejecting the proposed labeling change. This is likely even more true today, given the tightening of the standard. Justice Breyer acknowledged: "A drug manufacturer will not ordinarily be able to show that there is an actual conflict between state and federal law such that it was impossible to comply with both." In this light, the fact that a judge will be deciding whether the preemption defense succeeds may be of limited benefit, if the defendant must show an express rejection by FDA. That said, judges are unquestionably better equipped than juries to decide factual issues surrounding preemption.

Although the precise implications of the "fully informed" standard are not clear, it seems likely that a preemption defense will need more than evidence that FDA implied through informal communications that the agency would not have permitted a given labeling change. While it likely will remain difficult to prevail on a motion to dismiss, manufacturers should be able to argue for limited, targeted discovery on the issue of preemption to support a motion for summary judgment and will benefit from having judges, rather than juries, decide whether the defense applies. With this in mind, it will be increasingly important for there to be a clear written record of communications with FDA showing that specific warnings were proposed by the company and rejected by FDA. Doing so may be challenging, given the nature of labeling negotiations with FDA; the agency often provides feedback without expressly rejecting a proposal, leading the company to revise its proposal. Being prepared to later show that FDA was "fully informed" will require thinking ahead when negotiating labeling in the context of initial approval or postapproval labeling changes. 

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
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
 
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