Top Food and Drug Cases, 2022, & Cases to Watch, 2023

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

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Welcome, readers, to the 2023 edition of the Food and Drug Law Institute’s Top Food and Drug Cases volume, covering a selection of the most important decisions and other developments in the food and drug sector. Given the spirit of these times, it seems worth boasting that this introduction, and indeed the whole volume to the best of our knowledge, is “All Natural”—that is, created without any artificial colors, flavors, or intelligence. One almost suspects that any brief or publication that one reads without at least a partial contribution by generative AI may be the last. For now, though, although we retain the ebook format for this year’s publication, we are still firmly old-school in relying on the unique, meatware-generated insights of our roster of exceptional authors from law firms, industry, and academe to bring you the key cases of 2022 and the controversies to keep an eye on for the balance of 2023 and beyond.

The eleven chapters of this volume on specific legal developments, as always, range across all aspects of the food, drug, and medical device sectors, including those in other areas of law that have significant implications for the food and drug community. On behalf of the book’s panel of authors, we hope that the FDLI membership continues to find this volume informative, interesting, and worth archiving for future reference. As far afield as we sometimes wander, we inevitably return to FDA as the wellspring of law and guidance on food and drug issues. In this volume, Brigid DeCoursey Bondoc and KB Do tell us about Vanda Pharmaceuticals v. FDA, a case challenging FDA’s ability to shield review records relating to pending or unapproved drug applications from Freedom of Information Act disclosure. Anne Walsh reports on FDA’s efforts to stop a clinic from performing certain stem cell treatments by characterizing stem cells as drugs subject to premarket review and approval.

Other chapters report on cases where FDA is not a party, but that directly implicate industry’s relations with the agency. Sara Koblitz reviews the Jazz Pharmaceuticals v. Avadel CNS Pharmaceuticals case, a challenge to the types of patents that can be listed in the Orange Book that plays a central role in the Hatch-Waxman system of balancing the interest between innovator and generic pharmaceutical producers. Lynn Tyler analyzes limitations that can apply in False Claims Act whistleblower cases accusing a company of falsifying records in connection with pre-approval inspection of a pharmaceutical manufacturing facility. Mital Patel and Francisco Cabrera Lopez cover a case about the extent of preemption of consumer class action suits involving FDA-regulated labeling and packaging elements. And James Beck deserves special mention for not only taking on the important and controversial Supreme Court decision in Dobbs v. Jackson Women’s Health Organization, but for updating the chapter to account for frequent developments in the litigation challenges to FDA’s authority to approve abortifacient drugs in the wake of Dobbs in the weeks immediately prior to publication of this volume.

Dobbs is not the only high-profile 2022 case discussed in this year’s volume. Justine Lenehan and Dan Logan walk us through the implications of the Supreme Court’s use of the Major Question Doctrine in West Virginia v. EPA for its imminent review of Chevron deference, a question of major importance for all government agencies, including FDA. Bryant Godfrey and Tina Papagiannopoulos report on the criminal convictions of the executives of the now-infamous Theranos medical device company. Several of our chapters always cover private litigation in the food and drug areas.

Bill Janssen covers a class action alleging that a drugstore misleadingly implied that homeopathic products are comparable in efficacy to OTC drugs by shelving them in the same area. Rene Befurt, Anne Cai, Rebecca Kirk Fair, and Helene Rowland explore private class action litigation asserting “greenwashing” claims against major food and beverage companies. Anand Agneshwar and Jocelyn Wiesner describe an important Circuit Court development in the burdens of proof in private medical device product liability suits.

Our two perennial composite chapters summarizing important non-court-decision developments have plenty to report as always. Lauren Farruggia is joined by Stephanie Philbin and Steven Tjoe to describe this year’s important regulatory and enforcement developments from the past year, and Vanessa Fulton covers significant settlements negotiated with enforcement agencies in 2022. For our final chapter, our author team nominated in-progress cases that we think are worth watching for the balance of 2023. As always, there is more than a little to interest any active practitioner in the food, drug, and related spaces in these pages.

Not only are our chapters purely human-intelligence derived, there is also nothing artificial about the appreciation I and FDLI express for the contributions of our 2023 authors, some veteran, some new to this volume. We hope this summary of important 2022 matters in the food and drug area provides you with the same education and enjoyment as our previous volumes. On behalf of the entire Top Cases team, we wish our audience a happy, healthy, and safe year.

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.


Vanda Pharmaceuticals, Inc. v. Food and Drug Administration                     
Brigid DeCoursey Bondoc & Keunbong Do, Morrison & Foerster LLP

United States v. California Stem Cell Treatment Center
Anne K. Walsh, Hyman, Phelps & McNamara, P.C.

Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC
Sara W. Koblitz, Hyman, Phelps & McNamara, P.C.

(Alleged) False Statements to FDA Do Not Necessarily a False Claim Make 
Lynn C. Tyler, Barnes & Thornburg LLP

The Rapid Dissolution of Sapienza v. Albertson’s Companies, Inc.
Mital Patel & Francisco Cabrera López, Foley Hoag LLP                   

Dobbs v. Jackson Women’s Health Organization
James M. Beck, Reed Smith LLP

West Virginia v. Environmental Protection Agency
Justine E. Lenehan & T. Daniel Logan, Kleinfeld, Kaplan & Becker LLP

United States v. Elizabeth Holmes and Ramesh Balwani
Bryant Godfrey & Tina Papagiannopoulos, Foley Hoag LLP

Center for Inquiry Inc. v. Walmart, Inc. 
William M. Janssen, Charleston School of Law

Recent Cases on “Green” Messaging in Food and Beverage Company Advertising                               
Rene Befurt, Anne Cai, Rebecca Kirk Fair & Helene Rowland, Analysis Group

Defendants Beware: Did the Sixth Circuit Just Make Prescriber Testimony Irrelevant in Failure to Warn Cases?
Anand Agneshwar & Jocelyn Wiesner, Arnold & Porter LLP

Significant Digital Health and Cybersecurity Regulatory Developments, 2022                              
Stephanie Philbin, Steven Tjoe & Lauren Farruggia, Goodwin Procter LLP

2022 Significant Settlements 
Vanessa K. Fulton, Kleinfeld, Kaplan & Becker LLP

Food and Drug Cases to Watch in 2023