Introduction

August T. Horvath*

FDLI’s Top Food and Drug Cases contributor team is proud to present our 2024 edition. In this volume, we report on twelve significant lawsuits and legal issues from 2024 that we expect to have a significant impact on food and drug law practitioners for years to come. Our coverage includes government enforcement actions, civil and criminal cases, and significant appeals.

Appellate cases, with their precedential reach, are almost shoo-ins for inclusion in this volume, and we start at the top with the Supreme Court’s rare ruling in an FDA case, FDA v. Wages and White Lion; Ralph Hall reviews the Court’s holding on the limits of FDA’s policymaking authority and its implications. Ginger Pigott discusses the impact of the Fifth Circuit’s decision in Hickey v. Hospira on the implied preemption of failure-to-warn cases. Andrew Wasson describes Ipsen Biopharmaceuticals v. Becerra, a D.C. Circuit decision on the classification of products as between drugs and biological products. In the food sphere, Mital Patel and Danit Halberstein analyze In Re Beech-Nut Nutrition Company Baby Food Litigation, an important Second Circuit decision in class action litigation about heavy metal contamination in baby food. Another Circuit Court food case is chewed on by Rene Befurt, Anne Cai, and Sai Sindhura Gundavarapu, who discuss the Ninth Circuit’s Bryan v. Del Monte Foods decision regarding the reasonable consumer’s duty to read the entirety of food labels before filing suit for alleged deception. Anand Agneshar, Jocelyn Wiesner, and Tommy Huynh discuss how the procedural device of case management orders in multidistrict litigation has been used to weed out meritless claims in these large, multi-plaintiff cases.

The demise of Chevron deference continues to hang over the food and drug sphere, and James Beck discusses the Supreme Court’s decision in Loper Bright Enterprises v. Raimondo, a fisheries case with important implications for FDA’s authority. Tina Papagiannopoulos picks up this ball and discusses Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration, exemplifying how Loper Bright and related cases impact our practice area. Loper Bright also casts its shadow on Ohio v. Environmental Protection Agency, which Neal Fortin covers in this volume, defining the limits of government agency authority in air pollution rulemaking.

In another non-food-and-drug Supreme Court decision that nevertheless has important implications for FDLI’s members, Andrew Bentz, Colleen Heisey, and Matthew Krsacok discuss Corner Post, Inc. v. Board of Governors of the Federal Reserve System, in which the Court determined that the six-year statute of limitations under the Administrative Procedure Act runs not from when the challenged regulation is promulgated, but from when the individual plaintiff is injured.

In the criminal realm, Steve Johnson covers a trio of cases, United States v. Winslow, United States v. Malekina, and United States v. Daoust, all against individual executives of Magellan Diagnostics, and its implications for personal criminal liability of corporate officers for marketing misbranded devices.

For the second year, the National Advertising Division of the BBB National Programs weighs in with a discussion of an important decision from NAD’s 2024 docket, Lily of the Desert Nutraceuticals, relating to the marketing of the authenticity, quality, and purity of avocado oil, contributed by William Frazier.

Bill Janssen offers a Kubrickian take on Park v. Kim, one of the high-profile recent cases about the disastrous use of insufficiently supervised AI in litigation writing, which is sure to affect the practice of litigators in the food and drug sphere. And finally, Vanessa Fulton takes us through several significant settlements with government agencies in the food and drug space in 2024.

It is a fascinating, informative, and eclectic assortment of cases as always, and I thank our contributors for their diligent efforts and valuable insights. The year 2025 promises to continue to be chaotic in almost every way, and we look forward to future developments while wishing our readers the best in their various practices. We hope that you all enjoy the Annual Conference at which this ebook is being distributed, and the balance of FDLI events through the rest of the year.

*   August T. Horvath chairs the Advertising and Marketing Practice at Foley Hoag LLP in New York. August’s litigation, counseling, government enforcement, and self-regulatory practice spans all sectors of consumer products and services, with a particular focus on food and beverage labeling.