Introduction

August T. Horvath*

Welcome to the 2023 edition of FDLI’s annual roundup of Top Food and Drug Cases. This year, we have a bumper crop of thirteen chapters on individual cases or topics that got our attention during the past year, and we welcome several new contributors to the volume. As always, we span government enforcement, civil and criminal lawsuits, and significant appeals. This year we also introduce a chapter on a significant case in the industry self-regulatory sphere. We conclude with a summary of key 2023 FDA regulatory initiatives and sketch a few cases to watch in the coming months.

When the Supreme Court rules on cases in the food and drug space, it naturally gets our attention and makes this year’s list. Andrew Wasson describes the Supreme Court’s ruling in Amgen v. Sanofi, an important patent case with implications well beyond the biologics products that are the subject of the ruling. Bryant Godfrey and Tina Papagiannopoulos discuss the high-profile mifepristone approval case argued before the Court in March, Alliance for Hippocratic Medicine v. FDA.

The stakes are always high in criminal matters. This year, Lynn Tyler describes United States v. Facteau, an important First Circuit ruling on the First Amendment as a defense to criminal charges relating to off-label drug promotion. Steve Johnson reports on the criminal case United States v. Stoll, with its important ruling on individual criminal liability even at the non-executive level.

If you thought you might escape social media by opening this ebook, we have bad news for you. Three of our cases this year concern this topic. Brigid Bondoc and Atiq Chowdhury discuss Murthy v. Missouri, a high-profile case in which FDA and federal officials were alleged to have violated the First Amendment by “coercing” social media platforms to limit the spread of misinformation about COVID treatments and other issues. Somewhat relatedly, Jonathan Berman and Colleen Heisey look at Apter v. Dep’t of Health & Human Servs., in which plaintiffs successfully challenged FDA’s authority to combat the spread of misinformation regarding ivermectin as a COVID remedy by tweeting its own positions on appropriate treatment. Bill Janssen covers a key decision about the discoverability of social media activity in a New Jersey appellate court, and explains why the ruling is important to food and drug practitioners.

Other cases span the realm of pharmaceutical-related disputes. Justine Lenehan and Dan Logan cover one of the hottest legal issues of the past few years, the potential demise of Chevron deference via the case Relentless v. Dep’t of Commerce, and its implications for food and drug law. Ginger Pigott and Richard Tabura discuss Shikada v. Bristol-Myers Squibb, a state enforcement action alleging a deceptive practice in failure to disclose the differential efficacy of a drug across ethnic populations. Anand Agneshwar, Jocelyn Wiesner, and Tommy Huynh report on the Gilead Tenofovir Cases, in which the California Court of Appeal addressed the theory that a drug manufacturer can be negligent by not advising consumers that it knows of a different, not-yet-approved, medication that might be better for the same indication.

Food labeling class actions continue to litter the national litigation docket, and two chapters deal with aspects of these cases. Rene Befurt, Anne Cai, Sean Flanagan, and Tom Rahr discuss Horti v. Nestle Nutrition, concerning whether the placement of a protein drink on the shelf adjacent to other products for the treatment of diabetes contributed to a false impression that the protein drink is a diabetes treatment. Mital Patel covers the Ninth Circuit’s ruling in McGinity v. Procter & Gamble, clarifying the circumstances under which a reasonable consumer is expected to have reviewed a food’s ingredient statement before lodging a claim of deceptive advertising based on the package’s front panel.

This year we welcome Melissa Brown from the National Advertising Division of the Better Business Bureau National Programs, who describes a self-regulatory challenge to Novartis’ promotion of its Kisqali cancer drug.

I again express my heartfelt gratitude to our contributors for their diligent efforts and valuable insights as reflected in their contributions. Some of our authors have been contributing to this volume for longer than the seven years that I have been editing it, while others have joined at various times and some are brand new. To all regardless, I am equally indebted for making my job painless and for providing the heart and soul of this important and always eagerly anticipated FDLI publication.

On behalf of the entire team, we wish all of our gentle readers a happy and productive balance of 2024 and hope to see you at FDLI’s events.

* August T. Horvath is a partner and 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.