Top Food and Drug Cases, 2019, & Cases to Watch, 2020

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

“May you live in interesting times” is often said to be an ancient curse from China. This is untrue; the expression appears to have originated with British politicians in the 1930s. False designation of origin aside, however, the year 2020 has been interesting in precisely the ill-favored sense meant by the expression. Interesting circumstances forced the postponement of much of the work done by many organizations, including FDLI, and including specifically this volume. Most of the chapter manuscripts for the 2019 volume of FDLI’s annual roundup of the most important and interesting legal controversies affecting the food and drug industries had been submitted by March, when so much in U.S. society suddenly changed. After a hiatus of work on this volume and careful consideration, we decided, when FDLI’s 2020 Annual Meeting was rescheduled to October, that despite most of a year having passed since the end of 2019, the excellent contributions of our team of knowledgeable and experienced practitioners still deserved publication, at least in electronic form. Updated where necessary, they will be of immediate interest to practitioners and, we hope, like past volumes, will earn a permanent place on food and drug attorneys’ bookshelves—even if only their virtual shelves—as a permanent record of cases whose influence will endure.

As in the past, contributors from diverse backgrounds have each nominated and described a chosen case for this book. FDA enforcement actions usually figure prominently in our roundup, and this year, Anne Walsh and Sara Koblitz describe the D.C. District Court’s ruling limiting the FDA’s freedom to designate a product as either a “drug” or “device” in accordance with its enforcement preferences. James Beck covers an important new preemption case in pharmaceutical product liability, a subject that seems to come up reliably in issues of this volume. Lynn Tyler covers the first case in which the Federal Trade Commission sought judicial relief for an alleged abuse of the citizen petition process as a tactic for delaying generic entry. Dan Logan discusses a landmark Supreme Court ruling that appears to lower the bar for resisting Freedom of Information Act requests by demonstrating that the information sought is confidential. Ralph Hall reports on an important appellate decision on the Trump administration’s attempt to require disclosure of wholesale prescription drug prices in television advertisements. Jacqueline Chan describes a food company’s challenge to a state law seeking to define the meaning of a traditional meat so as to restrict its use by marketers of plant-based alternatives. Mital Patel discusses the Ninth Circuit’s en banc review of a First Amendment challenge to a California ordinance mandating large health warnings on outdoor signage advertising sugar-sweetened beverages. On the private class-action side, Bill Janssen covers an important ruling on causation in product liability cases, and I describe the Ninth Circuit’s elucidation of the “reasonable consumer” standard as it pertains to the likelihood of consumers being misled by beverage labels.

We welcome Justine Johnson to our crew of authors with her summary of significant settlements in 2019, and Lauren Farruggia and Jonathan Havens describe important regulatory and enforcement developments from the past year. In recognition that not much of the year 2020 is left as this volume goes to press, we have curtailed our joint coverage of cases to watch in 2020 for this volume, but we do cover two important appellate cases on which action is expected in what remains of 2020 or in early 2021.

We hope this belated roundup of the most important 2019 decisions in the food and drug area provides you with the same education and enjoyment as our previous volumes, and we look forward, hopefully without excessive optimism, to a return to our traditional format and publication timetable in 2021. Unlike many activities in society, activity in many legal and regulatory arenas was not much reduced in 2020, so we expect to have much more to fill you in on.

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.


Genus Medical Technologies, LLC v. U.S. Food and Drug Administration
Anne K. Walsh and Sara W. Koblitz, Hyman, Phelps & McNamara, P.C.

Merck Sharp & Dohme Corp. v. Albrecht
James M. Beck, Reed Smith LLP

FTC v. Shire ViroPharma: Start with a Bang, Finish with a Whimper
Lynn C. Tyler, Barnes & Thornburg LLP

Food Marketing Institute v. Argus Leader Media 
T. Daniel Logan, Kleinfeld, Kaplan & Becker LLP

Merck, et al. v. United States Department of Health and Human Services
Ralph F. Hall, Leavitt Partners LLC and University of
Minnesota Law School

Turtle Island Foods SPC d/b/a Tofurky Company v. Soman
Jacqueline Chan, Kleinfeld, Kaplan & Becker LLP

American Beverage Association v. City and County of San Francisco
Mital Patel, Foley Hoag LLP

In re: Mirena IUS Levonorgestrel-Regulated Products Liability Litigation (No. II)
William M. Janssen, Charleston School of Law

Becerra v. Dr Pepper/Seven Up, Inc.
August T. Horvath, Foley Hoag LLP

2019 Significant Settlements
Justine Johnson, Kleinfeld, Kaplan & Becker LLP

Significant Regulatory, Policy, and Enforcement Developments, 2019
Lauren Farruggia and Jonathan Havens, Saul Ewing Arnstein & Lehr LLP

Food and Drug Cases to Watch in 2020
William M. Janssen, Charleston School of Law, and Lynn C. Tyler,
Barnes & Thornburg LLP