Top Food and Drug Cases, 2020, & Cases to Watch, 2021

FDLI’s Top Food and Drug Cases is the companion volume to the popular panel at our Annual Conference.

As a general matter, “looking back at 2020” is a singularly unpleasant prospect for the vast majority of us. It is also a preoccupation that, many of us are increasingly suspecting with dread, we may not be entirely able to jettison for the foreseeable future, if not for the rest of our lives. Certainly from the viewpoint of mid-2021, that star-crossed year is very much still with us, upending everything from the Food and Drug Law Institute’s usual practice of publishing this volume in hard copy and distributing it at a face-to-face Annual Meeting to much broader aspects of our personal and professional lives. For those working in and around the pharmaceutical and health care industries, obviously, the impact of the global medical crisis of COVID-19 was even more profound. Efforts that, without too much exaggeration, could be called “heroic” were made in these communities and ultimately will have saved countless lives. The health, medical, and pharmaceutical industries have never been more important, nor the focus of more attention. The American legal and regulatory apparatus did its part to facilitate the response to the pandemic, including, where necessary, by stepping out of the way.

And yet, life goes on, after a fashion. In this year’s review of the most significant food and drug law cases and regulatory matters from 2020, COVID-19 does not play a major role. For the most part, the cases we cover here were controversies that began in previous years, and only in 2020 reached the point of a court decision or other outcome. As in prior years, the cases and developments covered by our estimable team of contributors range broadly across different aspects of food and drug law, and we even include some developments not strictly from food and drug law that we expect to have an impact on our areas of focus. We hope that FDLI’s members continue to find our volume informative, interesting, and worth archiving for future reference. Be sure to keep an eye on our Cases to Watch at the end of the book, as well, and see how we do on predicting the impact of what appear to our contributors to be the most important cases currently in progress.

As the wellspring of food and drug law, the FDA and related federal enforcement is always a subject of our chapters. This year, James Beck addresses the agency’s response to the COVID crisis through its invocation of the Public Readiness and Emergency Preparedness (PREP) Act, and the consequences for private litigation. Contributors Niall MacMenamin, Rene Befurt, and Genna Liu cover a D.C. Circuit decision that new FDA health warnings required on cigar products violated the Tobacco Control Act and the Administrative Procedure Act. Lynn Tyler describes the latest developments in a closely watched federal criminal prosecution for alleged off-label medical device promotion. Dan Logan and Jackie Chan report on a Supreme Court case that was argued in 2020 but decided shortly before we went to press in April 2021, limiting the Federal Trade Commission’s authority to seek restitution in actions under Section 13(b) of the FTC Act, with far-reaching implications for the powers of federal enforcement agencies, such as FDA, that have similarly worded enforcement authority.

We never neglect private litigation in these pages, and in this year’s volume, we cover important developments across the food and drug spectrum. Ralph Hall describes a key Ninth Circuit ruling on the parameters under which medical device product liability litigation can be preempted by FDA’s regulatory activities, with potential implications for drugs and biologics. Ginger Pigott and Michael Goodman cover a series of recent cases that have shaped the development of failure-to-warn claims in the prescription drug and device arena during 2020. Mital Patel and Jennifer Yoo discuss a recent spate of consumer class actions challenging flavor designators on a variety of food products such as ice cream and non-dairy milk beverages. Sara Koblitz explains an important Federal Circuit decision in the “skinny label” or “carveout” provisions of Hatch-Waxman in the context of pharmaceutical patent litigation. Bill Janssen discusses a key development in innovator liability theory in pharmaceutical product liability cases.

Our annual volume is never complete without our three roundup chapters. Lauren Farruggia and Jonathan Havens return to describe important regulatory and enforcement developments from the past year, and Justine Lenehan covers significant settlements between federal enforcement agencies and their targets over the course of 2020. And the chorus of authors weighs in, as noted above, on in-progress cases that we think are worth watching for the balance of 2021. As always, there is more than a little to interest any active practitioner in the food, drug, and related spaces in these pages.

We hope this summary of important 2020 decisions in the food and drug area provides you with the same education and enjoyment as our previous volumes. Last year, we wrote in this introduction that we looked forward “hopefully without excessive optimism, to a return to our traditional format and publication timetable in 2020.” Our optimism was slightly excessive, but we achieved the timetable part, and are happy to be back on schedule for both this volume and the FDLI Annual Meeting at which it will be released. We wish our audience the best for the next year, and look forward to our summary of next year’s top cases.

August T. Horvath is a partner and co-chair of the Advertising & Marketing Law Practice Group at Foley Hoag LLP. He litigates, counsels, and defends regulatory actions in false advertising and deceptive practices matters for clients in the food and drug as well as other industries.


AMG Capital Management, LLC v. Federal Trade Commission
Daniel Logan & Jaqueline J. Chan, Kleinfeld, Kaplan & Becker LLP

Department of Health and Human Services PREP Act Declaration and Amendments  
James M. Beck, Reed Smith LLP

Cigar Association of America et al. v. United States Food and Drug Administration et al.
Niall MacMenamin, Rene Befurt & Genna Liu, Analysis Group

Morris v. Biomet, Inc., Ebert v. C.R. Bard, Inc., and Zitney v. Wyeth LLC 
Ginger Pigott & Michael Goodman, Greenberg Traurig LLP              

In re Bard IVC Filters Product Liability Litigation 
Ralph F. Hall, Leavitt Partners LLC and University of Minnesota Law School

In re Zantac (Ranitidine) Products Liability Litigation
William M. Janssen, Charleston School of Law

GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc.
Sara W. Koblitz, Hyman, Phelps & McNamara, P.C.

U.S. v. Facteau: District Court Finally Upholds Misdemeanor Convictions for Off-Label Promotion
Lynn C. Tyler, Barnes & Thornburg LLP

The Scoop on the “Vanilla” Class Action Jurisprudence
Mital Patel & Jennifer Yoo, Foley Hoag LLP

2020 Significant Settlements
Justine E. Lenehan, Kleinfeld, Kaplan & Becker LLP

Significant Regulatory, Policy, and Enforcement Developments, 2020
Lauren Farruggia & Jonathan Havens, Saul Ewing Arnstein & Lehr LLP

Food and Drug Cases to Watch in 2021
James M. Beck, August T. Horvath, William M. Janssen, Sara W. Koblitz, Lynn C. Tyler & Anne Walsh