United States: How Might A Trump Administration Affect Our Sandbox?

Last Updated: November 17 2016
Article by James Beck

No, we're not here to muse about how our lack of contact with advanced extra-terrestrial civilizations might be due to an unfortunate proclivity for "intelligent" life to invent technology that destroys their home planets before developing technology that permits the colonization of other planets. We limit ourselves to the drug and medical device product liability space.

First, we reiterate our belief that under a Trump administration, the FDA's proposed – and oft-postponed − final rule, the one that seeks to abolish generic preemption by enacting regulations that likely violate the FDCA's "sameness" requirement for generic drugs, is kaput. When we learned earlier this year that the FDA had postponed the finalization date until after the election, we immediately pronounced it dead. We still believe that. We find it difficult to believe that a Trump FDA would continue a controversial Obama FDA proposal that has always been pursued as a sop to the plaintiffs' bar, a major supporter of the outgoing president. If there's one thing we know Donald Trump believes in, it is getting revenge.

Second, the odds of another pro-tort-preemption Supreme Court justice to fill the vacant seat created by Justice Scalia's death have increased significantly. The stark fact is that tort preemption has become a distinctly partisan issue on the Supreme Court. The two most recent drug/device Supreme Court decisions, PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 246 (2013), were both decided by five Republican appointees favoring preemption and four Democratic appointees opposing it. Had the outcome been different, we would have considered the ultimate survival of Mensing/Bartlett unlikely.

During the campaign, candidate Trump offered lists of over twenty possible United States Supreme Court appointees he might consider. That's too unwieldy for us to evaluate, but this recent 360 article identified four judges supposedly on a Trump shortlist: Hon. Don Willett (Texas Supreme Court); Hon. Diane Sykes (Seventh Circuit); Hon. Frederico (S.D. Fla.), and Hon. Joan Larsen (Michigan Supreme Court).


Justice Willett wrote one tort preemption opinion for the Texas Supreme Court, and it did not involve any of the usual suspects. In In re GlobalSanteFe Corp., 275 S.W.3d 477 (Tex. 2008), Judge Willett held that the Jones Act (involving ocean-going ships), did not preempt Texas statutes requiring, essentially, a Lone Pine-type order in silica injury cases, but did preempt state law concerning what was sufficient "injury." Preemption applied seemingly backwards in this case, with a non-preemption ruling actually benefitting the defense. None of Justice Willis' other preemption decisions involved federal preemption of state-law tort actions.


Judge Sykes has recognized federal preemption in a personal injury case. Fifth Third Bank v. CSX Corp., 415 F.3d 741 (7th Cir. 2005) (tort claims regarding railroad crossing injury preempted by federal railroad legislation). Otherwise, Judge Sykes' preemption cases have mostly involved ERISA, which is like shooting fish in a barrel because of ERISA's strong preemption clause.


As a district court judge, we thought it more likely that Judge Moreno would actually have encountered the kind of preemption decisions that DDLaw discusses. We were right. Not long ago, in Ward v. St. Jude Medical, Inc., 2016 WL 1208789 (S.D. Fla. March 28, 2016), appeal dismissed (June 23, 2016), threw out a PMA medical device case as entirely preempted. On the other hand, in a gun injury case, he found no complete preemption by the Commerce Clause and other federal enactments. Penelas v. Arms Technology, Inc., 71 F. Supp.2d 1251 (S.D. Fla. 1999). Judge Moreno also had a raft of ERISA preemption cases.


Justice Larsen of the Michigan Supreme Court does not appear to have written any preemption decisions.

With a Trump win, we're thus more optimistic now about the long-term survival of the "independence principle" and, indeed, it's logical extension to medical devices and beyond. Had the result been otherwise, we thought that the other side would abandon FDA proceedings and seek to overrule that principle outright after a new justice had been confirmed. For those of you not inclined to sort through the linked post, the independence principle was the Supreme Court's impossibility preemption definition in Mensing:

[W]hen a party cannot satisfy its state duties without the Federal Government's special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.

563 U.S. at 623-24. The president-elect has, of course, not made any policy statements concerning tort preemption, but given his business background, we suspect he would be more likely to respond favorably to a position backed by business than by business opponents, such as the Mensing/Bartlett dissenters.

Third, it is not likely that a President Trump likes California all that much. The state single-handedly is very likely to make him a popular-vote minority president, and even before that he wasn't cut much slack by most of the Hollywood crowd. Revenge, again – if nothing else. Thus, we doubt he would be in favor of California's effort to set itself up as the nationwide jurisdiction of last (or even first) resort for product liability litigation involving businesses anywhere in the country. Thus, we think it is a good bet that the new administration might support the recently filed Supreme Court petition for review in Bristol-Myers Squibb Co. v. Superior Court, 377 P.3d 874 (Cal. 2016).

Fourth, a number of the president-elect's supporters have either been proponents, or beneficiaries, of applications of First Amendment rights to corporate entities. A couple of examples of such decisions – rather far afield from drug/device − are Citizens United v. FEC, 558 U.S. 310 (2010), and Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751 (2014). Whatever their substantive merits, or lack of same, their logical extension to the truthful promotion of off-label uses, would also seem to be a development that the new administration could be convinced to stand behind. Thus, either internally (via the administrative procedure that the FDA just undertook) or externally (via litigation under United States v. Caronia, 703 F.3d 149 (2d Cir. 2012), and progeny), we see a more favorable prospect for the quicker demise of the FDA's longstanding prohibition against truthful off-label promotion.

On the other hand, president-elect Trump has not evinced particular support for First Amendment protections for the press (statements about libel laws) or for individuals (encouraging the ejection of protestors from meetings), so maybe a new administration would support restrictions on attorney advertising. The First Amendment could cut either way (or even both ways), and our side of the "v." should be ready to take full advantage.

Fifth, and more globally, this would seem like an auspicious time for the Chamber of Commerce to dust off some of their product liability-related legislative proposals – not necessarily limited to the drug/device – concerning product liability litigation. A uniform set of federalized defect standards worthy of a national economy, bringing an end to the eternal weight of asbestos litigation on American industry, express preemption for prescription drugs – any one of these may be possible. While product liability was certainly not one of the Trump campaign's top priorities, if given the opportunity, we doubt a Trump Administration would veto such measures, if passed by a more receptive Congress.

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.

James Beck
In association with
Related Video
Up-coming Events Search
Font Size:
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
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
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.


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.


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.


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.


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.


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.


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.